Background: Nutritional inadequacy remains a persistent public health concern in India, particularly among children aged 2–12 years. Despite advancements in national health metrics, high rates of stunting, wasting, and micronutrient deficiencies continue to affect this age group. Oral nutritional supplements (ONS) have emerged as effective interventions to help bridge dietary gaps, especially in low- and middle-income settings. This study aimed to assess the efficacy and safety of nutritional supplement (GROVIVA®), a scientifically developed ONS, in enhancing growth, nutritional status, and overall well-being in Indian children over a six-month period.

Methods: A total of 775 healthy children with a BMI below the 15th percentile were enrolled from six medical centers, with 720 completing the study. Participants consumed 30 g of nutritional supplement (GROVIVA®) mixed in 100 ml of milk or water twice daily alongside their regular diet. Growth metrics (height, weight, BMI), illness frequency, school absenteeism, gut health, and general well-being were evaluated at baseline, 3 months, and 6 months. Statistical analysis was conducted using t-tests and Analysis of Variance (ANOVA).

Results: Significant improvements were observed in weight (14.59 kg to 17.40 kg), height (99.22 cm to 103.29 cm), and BMI (14.48 to 15.98 kg/m²), particularly among children aged 2–7 years (P=0.0001). Illness frequency and absenteeism decreased, with 79% avoiding hospitalization. The supplement was well-tolerated, with reduced gastrointestinal complaints and no severe adverse events.

Conclusion: Nutritional supplement (GROVIVA®) effectively improved growth parameters and immune resilience in Indian children, supporting its role as a safe and beneficial nutritional intervention in at-risk pediatric populations.

Introduction

Growth is a well-established measure of nutritional status in children, particularly in their early years, and is important for physical development, cognitive function, and immunological health¹. Proper nutrition during this period has long-lasting effects, influencing not just immediate health but also future academic performance, work productivity, and overall well-being.

India faces significant health challenges, including maternal and fetal health concerns, nutritional disparities, and disease management, since poverty and malnutrition remain pressing issues despite rapid economic growth in the recent decade. About 27% of India’s population (26% in urban and 28% in rural areas) lives below the poverty line as determined by the expenditure to get an average of 2400 kcal per capita per day in rural areas and 2100 kcal in urban areas². The coexistence of poverty and poor nutrition contributes to inadequate child growth, micronutrient deficiencies, increased vulnerability to illnesses, and impaired physical and cognitive development³.

Malnutrition is a global health crisis. In the year 2022, an estimated 149 million children under the age of five were affected by stunting, 45 million were wasted, 13.6 million were severely wasted, and 37 million were classified as overweight or obese⁴˒⁵. In India, young children between 2 and 12 years of age experience high rates of stunting, wasting, and underweight, with undernutrition responsible for over 2 million deaths annually among children under five years⁶˒⁷. Furthermore, undernutrition accounts for 22% of India’s disease burden and leads to a 1.4% loss in Gross Domestic Product (GDP) due to reduced adult productivity⁶˒⁹.

Recent data from the National Family Health Survey (NFHS-5 2019-21) indicates some progress in child nutrition compared to NFHS-4 (2015-16). Stunting has declined from 38.4% to 35.5%, wasting from 21.0% to 19.3%, and underweight prevalence has reduced from 35.8% to 32.1%. However, if children’s undernutrition and growth deficiencies are not addressed early in childhood, some consequences can be irreversible, affecting their learning ability, academic performance during school years, and future productivity¹⁰˒¹¹.

Dietary patterns in India contribute to these challenges associated with undernutrition. According to the National Nutrition Monitoring Bureau (NNMB) survey (2006), Indian households consume less than the recommended intake of all food groups except cereals and millet. Indian diets, predominantly vegetarian, rely on cereals (wheat, rice, jowar, and bajra) for about 60% of their protein intake. However, cereal-based proteins are of lower biological value, leading to inadequate protein consumption in children⁸˒¹².

Evidence suggests that targeted nutritional interventions can reduce childhood stunting by 20% and improve cognitive development in children¹³. In this context, several studies conducted in developing countries have highlighted the positive impact of Oral Nutritional Supplements (ONS) in improving linear growth, physical development, and cognitive outcomes among children who are malnourished or at nutritional risk¹⁴˒¹⁵. When combined with dietary counselling, ONS has been shown to produce beneficial results in undernourished pediatric populations¹⁶˒¹⁷˒¹⁴. Although data from India remains limited, existing short- and long-term studies suggest the beneficial role of ONS as it improves growth indicators and strengthens resistance to infections among Indian children, particularly those who are malnourished or picky eaters¹⁶˒¹⁹.

Flavored nutritional supplements provide an easy and effective way to ensure adequate nutrition for children, especially those who are picky eaters. Nutritional supplement GROVIVA® is a scientifically developed supplement aimed at promoting healthy growth and development in children between the ages of 2 and 12. It features a blend of whey, casein, and soy proteins for a steady release of amino acids, probiotics to support gut health and immunity, dietary fiber to aid digestion, and docosahexaenoic acid (DHA) to support brain function, cognitive development, and vision. This study aims to evaluate the efficacy and safety of GROVIVA® in supporting growth, development, and nutritional status in children aged 2–12 years.

Methodology

STUDY DESIGN

Seven hundred seventy-five pediatric subjects participated in the study, which was conducted across six medical centers. Data was available for 720 subjects who completed the study. These subjects consumed 30 g GROVIVA® mixed with 100 ml water or milk twice daily, in the morning and evening for a duration of 6 months.

The inclusion criteria required subjects to be healthy children between 2 to 12 years of age, either male or female with Body Mass Index (BMI) below the 15th percentile. Exclusion criteria included children suffering from diarrhea, hormonal disorders, or any serious medical condition. Additionally, children who had participated in any other clinical trial were not included in the study.

PROCEDURES

The nutritional supplement used in the study consisted of 30g GROVIVA® dissolved in 100ml water or milk consumed twice daily in addition to a normal diet. The supplement contained five key signature nutrients which promote a healthy gut microbiome; and calcium, a key nutrient for bone health and development (as depicted in Table 1).

Table 1: Key nutrients

STUDY PLAN

A total of 775 subjects consumed GROVIVA® in four daily scoops of 15 g each (two in the morning and two in the evening) along with a normal diet.

During the baseline visit, a physical examination including height, weight, and BMI measurements was conducted. Follow-up visits for three- and six months were done to check the treatment compliance.

DATA COLLECTION

At the end of the six months, data were collected, and primary clinical parameters such as weight, height, BMI, and frequency of sick days were evaluated. Secondary clinical parameters included gut health, adverse events, hunger levels, and assessments of general well-being.

ETHICAL APPROVALS

The study was performed in compliance with the principles of the Declaration of Helsinki, the Ethical Guidelines for Biomedical Research on Human Participants, Indian Council of Medical Research, New Delhi 2006, Good Clinical Practice (GCP), and in compliance with local regulatory requirements. All participants provided written informed consent. EC approval number for the study was GSER/2024/BMR-CL/013 (Good Society for Ethical Research, New Delhi). The trial was registered at CTRI using CTRI/2024/02/063252.

STATISTICAL ANALYSIS

Data were meticulously analysed for each subject, and statistical methods such as t-tests and Analysis of Variance (ANOVA) were applied to assess changes in height, weight, and BMI. All subject data were recorded using Microsoft Excel, and statistical analysis was performed using SPSS software (version 26.0).

Results

Out of the 775 subjects who participated in the study, 64.7% were male and 34.4% were female. A total of 720 subjects completed the study (Figure 1). On GROVIVA® consumption, significant changes were observed in the weight, height, and BMI of the subjects from baseline to six months. The average weight at the baseline was 14.59 kg, which increased significantly to 17.40 kg after six months (P=0.0001). Similarly, the average height increased from 99.22 cm at baseline to 103.29 cm at 6 months with a significance of P=0.0001. The BMI also increased significantly from baseline to six months, showing a difference of 1.50 (P=0.0001) (Table 3).

Additionally, assessments were conducted on illness frequency and its impact on day-to-day activities. Among the 720 subjects who consumed GROVIVA®, 182 (25.27%) subjects did not fall ill, 353 subjects (49.02%) reported falling ill only once, and 112 subjects (15.55%) fell ill twice during the six months. Furthermore, 315 (43.75%) subjects did not miss school or classes at all, while 255 subjects (35.41%) missed school only once during the study period. A total of 569 subjects (79%) did not require hospitalization in the last 6 months. In terms of flavor preference, the most accepted flavor was Chocolate (n=400, 55.5%), followed by Vanilla (n=233, 32.4%), Mango (n=56, 7.8%), and Strawberry (n=31, 4.3%).

Table-2 Changes in Anthropometric Measures over 6 Months (N = 720)

Table-3 Data for Height, Weight / BMI in different age-groups 2-4 years, 5-7 years, 8-10 years & 11-12 years with their p-values months

a. Data for weight in different age-groups

b. Data for height in different age-groups

c. Data for BMI in different age-groups

When analysing anthropometric changes across years age groups (P = 0.0001). An increase in different age groups (Table 5), a statistically significant improvement in weight was observed in children aged 2-4, 5-7, and 8-10 years (P = 0.0001). Although children aged 11-12 years also showed an increase in weight, the effect was less pronounced (P = 0.0149). Improvements in height and BMI were most significant in the 2-4 and 5-7 years age groups. An increase in height was observed in older age groups (8-10 and 11-12 years), but it did not reach statistical significance. Similarly, while BMI improved across all age groups, the most statistically significant changes were seen in the younger cohorts (2-7 years) (P = 0.0001).

Table-4 Summary: Average Impact (all age groups)

Table 5: Age-based sub-group analysis

SAFETY

Throughout the study, GROVIVA™ was well tolerated by the subjects. No severe gastrointestinal (GI) issues were reported. Initially, 10 (1.39%) subjects reported diarrhea at the 3-month mark, but this number decreased to just 2 (0.28%) subjects by the end of six months. Similarly, 16 (2.22%) subjects experienced nausea at three months, but only 7 (0.97%) subjects reported it by six months. Constipation was reported in 17 (2.36%) subjects at three months and reduced to 12 subjects (1.67%) by the six-month mark. There were no reports of sick day leave due to GI issues.

A total of 100 subjects (13.88%) reported clinical symptoms such as fever, cough, wheezing, and difficulty in breathing within the first three months of the study. However, by the end of six months, the number of subjects experiencing these symptoms decreased to 49 (6.8%) with a significant reduction in their severity. These findings suggest that the reported symptoms were not directly related to the consumption of GROVIVA™ but improved with prolonged usage.

GROVIVA® clinical study support in growth in six months with the following  major highlights: