|Year : 2021 | Volume
| Issue : 2 | Page : 118-127
A randomized controlled trial to assess the efficacy and safety of children’s health supplement with micronutrient fortification to promote growth, health, and wellbeing in children
Priya Khare1, Omkar Kulkarni1, Anuj Agrawal1, Gayatri Ganu2, Madhavi Deodas3
1 Netsurf Research Labs Pvt. Ltd, Pune, Maharashtra, India
2 Clinical Research Unit, Mprex Healthcare, Pune, Maharashtra, India
3 Pune District Education Association, Pune College of Ayurveda and Sterling Hospital Research Center, Pune, Maharashtra, India
|Date of Submission||20-Nov-2020|
|Date of Decision||26-Nov-2020|
|Date of Acceptance||01-Mar-2021|
|Date of Web Publication||22-Apr-2021|
Senior Manager, R&D (Healthcare), Netsurf Research Labs Pvt. Ltd, Baner, Pune 411045, Maharashtra
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Background: Proteins are one of the strong pillars of sound physical health and cognitive abilities. Protein and micronutrient deficiency can hamper the health and growth of many children globally, delaying their physical and mental improvement and increase proneness to infections. The current research depicts the efficacy and safety of the children’s health supplement with micronutrient fortification to promote growth, health, and wellbeing in children. A multicenter randomized controlled trial. Material and Methods: Two centers one being a teaching institute with a hospital and the second one private hospital. Total 105 subjects visiting the out patient department (OPD) section participated of which 100 completed the trial with five being dropped out as lost to follow-up. Children’s health supplement (NRL/2019/5PNK) contains essential vitamins, minerals, herbal extracts together with a blend of whey, soy, pea, rice proteins, and milk solids. It was consumed as 90 days’ treatment in a dose of 10 g daily with 150 mL milk. Children’s health supplements improved anthropometric parameters and growth of children indicated by height-to-age and weight-to-age z-scores defined by world health organization (WHO). Results: There was a 45.70% increased physical endurance by children’s health supplement. Enhanced immunity status indicated by reduced illness episodes and missed school days. Children’s health supplements improved child’s eating behavior and cognitive performance better than the marketed product. It was found better in improving digestive behavior in children. Conclusion: Children’s health supplement found safe and effective in promoting growth, health, and wellbeing in healthy children.
Keywords: Nutrition, physical endurance, wellbeing, z-score
|How to cite this article:|
Khare P, Kulkarni O, Agrawal A, Ganu G, Deodas M. A randomized controlled trial to assess the efficacy and safety of children’s health supplement with micronutrient fortification to promote growth, health, and wellbeing in children. Int J Nutr Pharmacol Neurol Dis 2021;11:118-27
|How to cite this URL:|
Khare P, Kulkarni O, Agrawal A, Ganu G, Deodas M. A randomized controlled trial to assess the efficacy and safety of children’s health supplement with micronutrient fortification to promote growth, health, and wellbeing in children. Int J Nutr Pharmacol Neurol Dis [serial online] 2021 [cited 2022 May 18];11:118-27. Available from: https://www.ijnpnd.com/text.asp?2021/11/2/118/314379
| Introduction|| |
Scientific background and rationale
Protein and micronutrient deficiency can impede the health and growth of many children globally. It can delay their physical and mental improvement and increase proneness to infections. Protein deficiency could result in a negative nitrogen balance. Essential amino acids contribute the most to the mental and physical health of the child. There are several symptoms of protein deficiency that often are overlooked such as fatigue, lack of concentration, slowed growth, and lowered immunity. As per a study conducted by Abbott Laboratories, one in seven school-aged children in the US is not consuming enough protein; the numbers are almost double in developing countries like India. Protein nutrition is one of the strong pillars of sound physical health and cognitive abilities. Undernutrition with proteins and infection is a vicious cycle, along with deteriorating illness and declining nutritional status. Protein undernutrition could be the main cause of the immunocompromised state, such children are more prone to gastrointestinal (GI) and respiratory infections, and it is important to consider opportunistic infections such as viruses, gram-negative bacteria, fungal, and parasitic infestations. Undernutrition, low growth rate, overweight, micronutrient deficiencies, and osteopenia are nutritional confounders that affect the impairment neurologically.
The stage of growth in children is defined by the attributes of height and weight. For attaining the same, all nutrients must be ingested, absorbed, metabolized, and excreted properly since better assimilation translates to nutritional sufficiency. In the case of children, their metabolism is a constantly evolving mechanism and not a fixed combination that could work, but easy digestibility will make difference in better assimilation. Families with a low socioeconomic status often have little access to micronutrient-rich foods like fruits, vegetables, meat, fish, and dairy. In affluent profile families, protein malnourishment can result from excessive ingestion of fatty, carbohydrate, and sugar-rich food. A wide range of traditional as well as contemporary health products is available for children and the pressure is on the homemaker to keep the health of the children up to the mark. There is a great need for a researched product with proven safety and effectiveness to completely rely on the product for child consumption.
Netsurf Communications Pvt. Ltd. has developed children’s nutraceutical supplement (NRL/2019/5PNK, henceforth will be termed as test product) containing protein with micronutrients fortification, with a natural product designed to promote general health and wellbeing of children, to support the optimum natural growth and development of children, enhanced immunity, and to the maintenance of adequate natural cognitive function. It contains essential vitamins, minerals, herbal extracts together with a blend of whey, soy, pea, rice, and milk solids. It is in powder form, 10 g of it is mixed in water or milk for consumption. The current research depicts the efficacy and safety of the test product with micronutrient fortification to promote growth, health, and wellbeing in children.
The hypothesis of the research was “Was test product as effective as the marketed comparator in safety and efficacy and were there any additional benefits of test product against the marketed product to promote growth, health, and wellbeing in children?”
| Material and methods|| |
The study was a randomized, double-blind, parallel-arm, controlled clinical trial. The subjects were randomized to test the product or marketed product (market comparator) group (comparator is the leading brand of protein supplement for children) in a 1:1 ratio.
The study was initiated only after written approval is obtained from the Independent Ethics Committee (IEC) and subsequent registration of the study on the clinical trial registry of India (CTRI) website. The study was conducted as per approved protocol and as per Good Clinical Practices guidelines.
Data availability and CTRI registration
After getting approval from the ethics committee, the study was registered on the CTRI website. Patients were enrolled in the study only after registration of study on the CTRI website. The Registration details of the study are: CTRI/2019/11/021993 (registered on November 13, 2019) − Trial Registered Prospectively.
Selection criteria of subjects
The subjects along with their guardians/parents visiting out patient department (OPD) of the two trial sites were screened for the inclusion and exclusion criteria for the said trial. The subjects who fulfilled inclusion criteria and did not meet any exclusion criteria had been selected to participate in the trial.
Inclusion criteria for the study were: children aged 6 to 11 years inclusive (both gender), providing consent by an understanding of the study and willingness to participate as evidenced by subject’s parents and/or legal guardian’s voluntary written informed consent; ready for compliance; and is willing, able, and likely to comply with all study procedures and restrictions.
Exclusion criteria for the study
Following were the exclusion criteria: the subject with a known allergy or intolerance to the study product or ingredients, on a special diet and cannot consume the study product, subject with a current illness requiring hospitalization, subject with a GI infection and/or acute diarrhea at the time of inclusion in the study, and the subject on medication that could affect absorption/metabolism of study product. The subject is diagnosed with recurrent respiratory infections due to cystic fibrosis, active tuberculosis, acute hepatitis B or C or HIV, malignancy (as per history in the medical records) were excluded, as per discretion of investigation; subject with a history of diabetes (as per history and documentation in the medical records), subject been on antibiotic therapy within the last 1 month before the start of the study (before study day 1), subject with dysphasia, aspiration risk, and difficulty in swallowing due to acquired/congenital abnormalities that would hamper oral intake of the study product were excluded (as per history and documentation in the medical records); subject with a clinically significant nutritional deficiency requiring specific treatment with any other nutritional supplement (not study product) as diagnosed by the investigator were excluded for the safety concern.
Test product and a market comparator product were administered to subjects 10 g in the morning daily with 150 mL milk for 90 days’ treatment period. The subjects along with their guardian/parent were asked to visit over a schedule of day 30, 60, and 90 as follow-up visits.
The primary objectives of the study were to evaluate the efficacy of children’s health supplement with micronutrient fortification by assessing growth − change in weight [world health organization (WHO) z-score], anthropometry tests, questionnaire for evaluation of development and behavior, physical endurance by VO2 max in comparison with the market comparator.
The secondary objectives were assessment of immunity profile via a number of recurrent acute upper respiratory tract infection (URTI), number of sick days per month assessed by the presence of any acute URTI, number of days required to recover from an episode of infection, appetite score questionnaire, emotional quotient questionnaire, safety biochemical tests, serum brain-derived neurotrophic factor (BDNF) levels, adverse events profiling, etc., in comparison with the market comparator.
There were no changes in objectives after the commencement and completion of the trial. All the outcomes were assessed at each time point of the study, that is, on days 0, 30, 60, and 90.
Sample size consideration
Sample size calculation is derived taking considerations of primary and secondary outcomes by a qualified statistician. The software used for analysis is SPSS version 10.0.
The safety biochemical parameters were analyzed from baseline to end of the study using student paired and unpaired t test. Primary outcomes at baseline and every visit till the end of the study were analyzed by analysis of variance (ANOVA) followed by multiple comparison tests. Other variables like a global assessment for overall improvement, tolerability of study drugs, and adverse events were analyzed by the chi-square test.
Randomization sequence generation
It was a randomized study wherein all the subjects were randomly allocated (as per computer-generated randomization list) to either one of the two treatment arms in a 1:1 ratio. Subjects were randomized to either the test group or marketed product group.
Screening visit, baseline visit (day 0), visit 1 (day 30), visit 2 (day 60), visit 3 (day 90).
Allocation concealment mechanism
Sequentially numbered containers as per enrollment number were used to conceal the randomization in identical primary packaging.
The identical packaging and flavor of both the interventions were kept similar to keep both investigators as well as the subject blind of which drug he/she was receiving.
Principle investigator obtained informed consent from subjects’ guardians or parents visiting at OPD of research sites and randomized the subjects as per the computer-generated list allots subject to the respective group after fulfillment of their inclusion and exclusion criteria. The subject’s demographic details were recorded. The subject underwent clinical examination (general and systemic examination). The subject’s medical, surgical, and treatment history was recorded. The current medications of the subject if any were noted in the case record form. The subject was considered for further evaluation as per the inclusion and exclusion criteria. Blood samples for biochemical tests were collected. During the screening visit and the entire study duration subject’s guardians were advised to refrain subject from consuming antioxidant agents, vitamins, health supplements, nutraceuticals, Ayurvedic, Siddha, Unani, or herbal/homeopathic medicines. On baseline visit, the subject was recruited in the study if he/she fulfilled all the inclusion criteria. Subjects were then randomized to one of the two study groups as per the computer-generated randomization list. The subject’s parent/guardian was asked for the occurrence of any adverse event during the screening period. The subject underwent clinical examination (general and systemic examination). Subject’s growth − weight change (WHO z-score), anthropometric parameters, and questionnaire, were assessed along with VO2 max.
At baseline visit and every follow-up visit (except last follow-up visit), as per the computer-generated randomization list, the subject’s guardians were provided with an investigational product with instructions for its use. Product compliance was assessed by the investigator on every follow-up visit. Subjects who continuously missed dosing for >3 consecutive days or total missed dose >9 days during the study period were treated as dropouts. The records of the compliance were kept as a telephonic log (calls to the subject’s parents).
Subjects were called to respective study sites for follow-up visits after every month up to 3 months after the baseline visit. On every follow-up visit, all the parameters performed on the baseline visit are assessed.
On the third follow-up visit (i.e., day 90) all the assessments of the subject were repeated along with the biochemical tests from blood samples. Global improvement and palatability assessment were carried out by the subject guardian as well as the investigator. After completion of 3 months of study treatment, all the subjects were asked to stop trial medications and take the advice of the investigator for further treatment. The participant’s details are explained in [Figure 1].
| Results|| |
In the present study, 105 subjects were screened. Out of 105 subjects, five lost to follow-up in the study. Total 100 subjects were considered evaluable cases at the end of the study: 50 in test and 50 in the marketed product treated group.
Out of 100 completed subjects, the mean age of test group subjects was 8.5 ± 2.44 years and the mean age of marketed product group subjects was 8.89 ± 3.01 years; the difference was statistically insignificant. The ratio of 50:50 for males and females was maintained during recruitment of the study.
Assessment of physical endurance (VO2 max)
There was a nonsignificant difference between VO2 max calculated by PREFIT test in test product and marketed product treated group at baseline and till day 60. After day 90, there was a significant increase (P < 0.05) in VO2 max calculated by PREFIT test with the test product treated group as compared to marketed product. Within-group analysis, test product treated group demonstrated 45.7% and marketed product treated group showed 21.25% increase in VO2 max at day 90 when compared to the baseline value of the respective group as shown in [Table 1].
|Table 1 Assessment of maximum aerobic capacity (VO2 max) between the groups|
Click here to view
Assessment of WHO z-score
There was a nonsignificant difference in height-to-age and weight-to-age z-score in the test product and marketed product treated group at baseline till day 90. In the case of within-group analysis, the test and marketed product treated group demonstrated significant improvement in height-to-age and weight-to-age z-score at day 30, 60, and 90 when compared to the baseline value of the same group as shown in [Table 2].
Assessment of Child Eating Behavior Questionnaire
The Child Eating Behavior Questionnaire was assessed based on the response from the subject’s parent/guardian. After day 60, there was significant (P < 0.001) improvement in certain domains in eating behavior like food responsiveness, enjoyment of food, eating speed (reduced sluggishness) in the test product treated group than marketed product treated group. After day 90, there was significant (P < 0.001) improvement in certain domains in eating behavior like food responsiveness, emotional overeating (got reduced after treatment), enjoyment of food, desire to drink, satiety responsiveness, eating speed (reduced sluggishness after treatment), emotional undereating (got reduced after treatment) in test product treated group than marketed product treated group as shown in [Table 3].
|Table 3 Assessment of Child Eating Behavior Questionnaire between the groups|
Click here to view
Assessment of Emotional Intelligence Questionnaire
The Emotional Intelligence Questionnaire was assessed based on the response from the subject’s parent/guardian. After day 90, there was significant (P < 0.0001) improvement in scores of the following domain of the questionnaire, such as social skills, motivation, self-regulation, self-awareness, and empathy in test product treated group than marketed product treated group as shown in [Table 4].
|Table 4 Assessment of Emotional Intelligence Questionnaire (EIQ) between the groups|
Click here to view
Assessment of Evaluation of Development and Behavior Questionnaire
The Development and Behavior Questionnaire was assessed based on the response from the subject’s parent/guardian. After day 90, there was a significant improvement (P < 0.0001) in all domains of Development and Behavior score in test product than marketed product treated group as shown in [Table 5].
|Table 5 Assessment of Evaluation of Development and Behavior score between the groups|
Click here to view
Assessment of anthropometric parameters
According to the results obtained regarding anthropometric parameters of test and marketed product treated groups, it was observed that there is no significant difference in both the groups in parameters like body weight, circumferences, body mass index (BMI), arm fat index, etc. In the within-group analysis, test product and marketed product treated group showed significant improvement (P < 0.05) in anthropometric parameters at day 90 compared to baseline reading with height, weight, and BMI as shown in [Table 6].
Changes in mean serum BDNF level
Mean serum BDNF levels were within normal limits at baseline visit in both the groups. After completion of the treatment, no significant change in serum BDNF level was observed in both the groups, that is, test and marketed product treated groups. If compared within the groups, there was a nonsignificant improvement in serum BDNF when 90 days readings were compared to baseline values of the respective groups as shown in [Table 7].
| Discussion|| |
Physical fitness is an indicative sign of health in children and adolescents. For instance, low fitness levels are associated with a higher risk of developing obesity, cognitive disorders, and musculoskeletal weakness later in life. In this study, to assess the physical endurance, a modified 20 m PREFIT project framework was utilized. There were correlations and equations based on heart rate, distance covered, and velocity of running in the stipulated distance. It will give us a fair idea about the cardiovascular fitness of children. In the present study, after day 90, there was a significant increase (P < 0.05) in VO2 max calculated by PREFIT test with test product treated group as compared to marketed product. There was 45.70% VO2 max improvement in the test product treated group compared to 21.25% improvement in the marketed product treated group. The results are indicative of muscle strength improvement and thus physical stamina.
WHO recognizes a system by which a child or a group of children can be compared for the rate of growth, to the reference population: z-scores (standard deviation scores), percentiles, and percent of median., For population-based assessment including surveys and nutritional surveillance, the z-score is widely recognized as the best system for analysis and presentation of anthropometric data because of its advantages compared to the other. Mainly height-to-age and weight-to-age are interpreted by using the z-score classification system as a great indicator of growth rate and its adequacy. The z-score system expresses the anthropometric value as several standard deviations or z-scores below or above the reference mean or median value.
The current WHO recommendation is to use the z-score for grading undernutrition. Children who are with 1 standard deviation (SD) below the reference median, that is, around −1 are borderline undernourished, more than 2 SD below the reference median (i.e., a z-score of less than −2) are considered to be undernourished, that is, to be stunted, wasted, or to be underweight. Children with measurements below 3 SD (a z-score of less than −3) are considered to be severely undernourished.
In the present study, children who represented marginal undernourishment though were not having severe symptoms and were randomly sampled. There was a nonsignificant difference in height-to-age and weight-to-age z-score in the test product and marketed product treated group at baseline. After 30, 60, and 90 days there was a nonsignificant difference in height-to-age and weight-to-age z-score between the test product and marketed product treated group. The z-score as height and weight indicator with age were improving in magnitude but the comparison was nonsignificant. In the case of intragroup analysis, the test product treated group and marketed product treated group demonstrated significant improvement in height-to-age and weight-to-age z-score at day 30, 60, and 90 when compared to a baseline value of the respective group. It indicated that the test product was equally good in promoting the growth rate of the child.
Dietary habits are shaped at a young age and maintained during later life with tracking over time. Eating behaviors established in childhood persist, with implications such as fussiness, undernourishment, or obesity. It is very important thus to check if the dietary supplement in terms of the blend of macro- and micronutrients are offering some sort of positive impact in child’s eating behavior. In the present study, the behavior is assessed through a well-researched and validated Child Eating Questionnaire. There are a set of questions to be assessed from the parent/guardian of the child in the following domain: food responsiveness, emotional overeating, enjoyment of food, desire to drink, satiety responsiveness, sluggish eating, emotional undereating, etc. The response can measure the eating habit and role of nutritional supplement in improving this domain to get positive and nourishment contained eating habits.
In the present study, after day 90, there was a significant (P < 0.001) improvement in scores of all domains in the test product treated group compared to the marketed product treated group. There is an important consideration of better absorption and assimilation of nutrients from nutritional supplements to bring about changes in the eating habits in the child as a result of nutritional sufficiency. It can be concluded that the test product proved better to alter the eating habits and behavior in children than the marketed product.
The appetite score was assessed and found to be improved in both test and marketed product treated groups. Almost 70% of parents of subjects from both the groups complained of less appetite on the baseline for their children. But there was a significant difference in appetite score after day 60 and day 90 in the test and marketed product treated group. It shows test product better performing to improve appetite which will inculcate good eating habits thus optimal food response to avoid under- and overeating in children.
It is a well-researched fact that there is a correlation between emotional intelligence and eating misbehavior in school-going children. The emotional quotient and intelligence is the major key component in the development of child to grow as a socially responsible person. Emotional intelligence is related to the following domains: social skills, motivation, self-regulation, self-awareness, and empathy. The questionnaire assessing the emotional intelligence domain was implemented in the present study to be answered by the parent or guardian of the subject to come to the score representing the emotional intelligence orchestra of the child. It was found that after day 90, there was significant (P < 0.0001) improvement in scores of the following domain of the questionnaire: such as social skills, motivation, self-regulation, self-awareness, and empathy in the test product treated group than marketed product treated group. This is indicative of the potential of the test product to find a link between physical nutrition and psychological soundness. The result could be due to the improved eating pattern, appetite, nutritional sufficiency by the supplement, and joint effort of Brahmi (Bacopa extract) from the test product as it is reported to possess effectiveness in improving the psychosomatic functionalities at an early age.
The overall development of the child is quite incomplete without cognitive and behavioral development in the right way. These aspects are studied in this research through a standard questionnaire involving a set of questions to be answered by the parent or guardian of the child. There are strong links between macro- and micronutritional sufficiency and behavior and cognitive development. In turn, better cognition and behavior uplift a child’s self-image and thus train the self-esteem to take newer challenges and develop.
Gross motor skills are helping the child to be active, competitive, and alert in group or isolation and require physical and mental stamina which can be built by a correct nutritional supplement. Attention and concentration not only help the child to improve in academics but also can cultivate nature to work in a team. Children with attention deficit could face a lot many psychosocial challenges in the later stages of their lives. On the contrary to this overactivity through less attention, the extreme polar condition is passivity and child’s tendency of being passive and not taking interest in the academics as well as interactive opportunities. It could be reversed by counseling and therapies but the nutritional balance and omega supplements can play a key role in improving this condition. Planning, perception to space, and visual forms and figures are the part of the neurological development of a child to perform more complex processes in the later stage of life along with verbal and spoken language communications. Cognitive development performs a pivotal role in child development and always is a major concern from the parent’s perspective.
With the current results of scores of the questionnaire in the present study, it could be concluded that all the set of developmental parameters are better improved (significance: P < 0.001) at day 90 by test product when compared to the marketed product. Academic and social skill scores were also improved in the test-treated product than the marketed product.
Bacopa monnieri, popularly known as Brahmi, has been traditionally used in Ayurveda for ages for its memory-enhancing properties. The reported study which planned to evaluate the effect of B. monnieri on the memory of students for 6 weeks revealed improved memory, both visual as well as verbal. B. monnieri is reported to improve working memory and short-term verbal memory in children.
According to the results obtained regarding anthropometric parameters of test and marketed product treated groups, it was observed that there is an increase in height, weight, BMI, circumferences of chest, waist, and head, etc., as the children are under growing phase but no significant difference in both the groups in parameters like body weight, circumferences, BMI, and arm fat index, etc.
As a clinical measure of the immune status of the children, we had considered episodes of recurrent respiratory tract infection (RTI) and illness episodes as a scale. Following are the results of the current study: in the test group, at baseline, 20 subjects of the test group reported an average of at least 20 events of RTI in the previous month. On the contrary, 10 subjects (20%) reported recurrent episodes of RTI during 3 months period. The number frequency of events was 10 events with 2 to 3 days duration and was resolved completely before completion of the study duration. In the test group, the total missed days of the subjects were 13 days.
In the marketed product group, at baseline, 15 subjects of the test group reported an average of at least 18 events of RTI in the previous month whereas nine (17.64%) subjects reported 12 events of recurrent RTI during the 3 month test period and was found to be completely resolved in 2 to 3 days and total missed days of the subjects were 15 days. If compared between the groups, there was no significant change in both the groups. Test product improved immune status of the child by reducing illness episodes and thus the missed school days as a result of protein sufficiency and development of strength to combat the infections. Ashwagandha extract used in the test product is thought to be an excellent immunomodulator in action. It is reported to possess anti-inflammatory, antioxidant values. Many clinical trials have witnessed the usefulness of Ashwagandha to promote both innate and acquired immunity. The micronutrient supplementation like vitamin C and D in the test product has immunity-building potential. Colostrum used as an ingredient in test products possesses immunity modifying properties that could contribute to the ability to cope up with.,BDNF is a protein of the neurotrophin family. It is expressed in human brains. It is associated with synaptic plasticity, connectivity, and neuroprotection. It also serves an important role during neurological development through the regulation of neural circuit development. BDNF plays an important role in learning and memory at an early age. It is found in most concentrations in the hippocampus region of the brain. BDNF is an important factor in neurodevelopment. It is reported in a research that serum BDNF may present an inverse correlation with the intelligence, attention, and cognition of preschool children with neurodevelopmental disorders such as intellectual disability, and attention-deficit/hyperactivity disorder (ADHD) can very well be correlated to abnormal free peripheral BDNF. In the present study, the serum BDNF levels in both the group were within the normal range at baseline and did not produce any significant change after treatment with test and marketed product treatment for 90 days.
As an assessment of adverse event profile, there was no significant difference in both groups. Both groups represented mild adverse event episodes like fever, injury, dry and irritable eyes, cold, muscle pain, etc. All these adverse events were mild in severity. These adverse events were resolved completely after 1 to 3 days with rescue medication. Study treatment was not stopped during these adverse events. All these adverse events were not related to the study drug. Global assessment for overall improvement by subject parent/guardian and investigator revealed that children’s health supplement demonstrated much-very much overall improvement in both treatment groups. Excellent tolerability of both the drugs was reported by subjects and physicians at the end of the study. No significant post-treatment change in any of the laboratory investigations was observed in both the groups like complete hemogram, liver, kidney, lipid, and thyroid profile tests. In the present study, there were nonsignificant changes in random blood sugar and hemoglobin A1c (HbA1c) in children’s health supplement treated and marketed product treated group. There is no significant change in serum calcium levels in both groups. In the present study, there was a significant (P < 0.05) reduction in total cholesterol but no change in triglycerides (TG), high density lipoprotein (HDL), low density lipoprotein (LDL), and very low density lipoprotein (VLDL) in the children’s health supplement treated group at day 90 of treatment. There was no significant posttreatment change in vitals such as pulse rate, blood pressure, body temperature, and respiratory rate was observed in both the groups, suggesting both the drugs were safe in human subjects. Thus children’s health supplement with micronutrient fortification is safe and effective in children. Children’s health supplements and marketed products both presented excellent palatability and mixability with milk. There was 100% compliance for both children’s health supplements and marketed products by subjects during the study. The trial complies external validity, also called generalizability as these results can be generalized in population as the broader inclusive criteria yet potentially excluding the subjects may prove inappropriate for the study had made the generalization feasible.
| Conclusion|| |
The children’s health supplement is safe and effective in promoting growth, health, and wellbeing in healthy children. It improved the growth of children indicated by height-to-age and weight-to-age z-scores defined by WHO was comparable with the marketed product. Height, weight, BMI, and circumferences of chest, waist, and head were increased as an indicator of child’s physical growth in children’s health supplement as well as marketed product treated groups. There was 45.70% increased physical endurance by children’s health supplement treatment indicated as VO2 max compared to baseline. This can be linked to physical stamina. Enhanced immunity status was indicated by reduced illness episodes and missed school days in children’s health supplement and marketed product treated groups. Children’s health supplement improved child’s eating behavior better than the marketed product. It reduced fussy eating; also food responsiveness and satiety of food score as per the questionnaire was improved after children’s health supplement treatment as compared to marketed product. Emotional intelligence score was better in children’s health supplement treatment than the marketed product. Improved cognitive performance was seen in children’s health supplement treatment than the marketed product. The children’s health supplement was found better in activity than the marketed product counterpart in improving digestive behavior in children.
Financial support and sponsorship
This study was funded by Netsurf Communications Pvt. Ltd.
Conflicts of interest
There are no conflicts of interest.
| References|| |
Blumberg SJ, Bramlett MD, Kogan MD, Schieve LA, Jones JR, Lu MC. Changes in prevalence of parent-reported autism spectrum disorder in school-aged US children: 2007 to 2011-2012. US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics; 2013.
Michaelsen KF, Larnkjær A, Mølgaard C. Amount and quality of dietary proteins during the first two years of life in relation to NCD risk in adulthood. Nutr Metab Cardiovasc Dis 2012;22:781-6.
Maillard G, Charles MA, Lafay L et al.
Macronutrient energy intake and adiposity in non-obese prepubertal children aged 5–11 y (the Fleurbaix Laventie Ville Santé Study). Int J Obes Relat Metab Disord 2000;24:1608-17.
Ministers N. Nordic nutrition recommendations NNR 2004, integrating nutrition and physical activity. Ministers. NCo, Editor 2005.
Budek AZ, Hoppe C, Ingstrup H, Michaelsen KF, Bugel S, Mølgaard C. Dietary protein intake and bone mineral content in adolescents: the Copenhagen Cohort Study. Osteoporos Int 2007; 18:1661–7.
Mora-Gonzalez J, Cadenas-Sanchez C, Martinez-Tellez B et al.
Estimating VO 2 max in children aged 5–6 years through the preschool-adapted 20-m shuttle-run test (PREFIT). Eur J Appl Physiol 2017;117:2295-307.
de Onis M, Blössner M. Programme of Nutrition. Geneva: World Health Organization 1997. pp. 1-67.
Montano Z, Smith JD, Dishion TJ, Shaw DS, Wilson MN. Longitudinal relations between observed parenting behaviors and dietary quality of meals from ages 2 to 5. Appetite 2015;87:324-9.
Sellen D. Physical status: the use and interpretation of anthropometry. Report of a WHO Expert Committee. WHO technical report series no. 854. pp. 452 (WHO, Geneva, 1995). Swiss Fr 71.00. J Biosoc Sci 1998;30:135-44.
World Health Organization (WHO). The use and interpretation of anthropometry: report of a WHO expert committee. World Health Organ Tech Rep Ser 1995;854:312-409.
Filaire E, Larue J, Rouveix M. Eating behaviors in relation to emotional intelligence. Int J Sports Med 2011;32:309-15.
Dave UP, Dingankar SR, Saxena VS et al.
An open-label study to elucidate the effects of standardized Bacopa monnieri extract in the management of symptoms of attention-deficit hyperactivity disorder in children. Adv Mind Body Med 2014;28:10-5.
Kumar N, Abichandani LG, Thawani V, Gharpure KJ, Naidu MU, VenkatRamana G. Efficacy of standardized extract of Bacopa monnieri (Bacognize®) on cognitive functions of medical students: a six-week, randomized placebo-controlled trial. Evid Based Complement Alternat Med 2016;2016:4103423.
Usha PD, Wasim P, Joshua JA et al.
BacoMind®: a cognitive enhancer in children requiring individual education programme. J Pharmacol Toxicol 2008;3:302-10.
Malik F, Singh J, Khajuria A et al.
A standardized root extract of Withania somnifera
and its major constituent withanolide-A elicit humoral and cell-mediated immune responses by up regulation of Th1-dominant polarization in BALB/c mice. Life Sci 2007;80:1525-38.
Wintergerst ES, Maggini S, Hornig DH. Immune-enhancing role of vitamin C and zinc and effect on clinical conditions. Ann Nutr Metab 2006;50:85-94.
Gunville C, Mourani P, Ginde A. The role of vitamin D in prevention and treatment of infection. Inflamm Allergy Drug Targets 2013;12:239-45.
Yeom CW, Park YJ, Choi SW, Bhang SY. Association of peripheral BDNF level with cognition, attention and behavior in preschool children. Child Adolesc Psychiatry Ment Health 2016;10:10.
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]