Combination of Oral Nutritional Supplements and Dietary Counseling Is More Effective than Dietary Counseling Alone in Improving Growth Indicators among Undernourished United States Children: A Randomized Controlled Clinical Trial
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Background Approximately 14% of United States children show ≥1 indicator of undernutrition, highlighting an opportunity to deepen research evaluating oral nutrition supplements (ONSs) on growth in United States children. Objectives The purpose of this 2-arm, individually randomized, parallel controlled trial was to evaluate the impact of ONS plus dietary counseling (ONS+DC) compared with DC alone on growth in undernourished United States children (36–107 mo) over 120 d. Methods Over the 120-d intervention, participants [mid-upper arm circumference (MUAC) or body mass index (BMI)-for-age z -score between −3 and −1) attended 2 DC sessions, and ONS+DC group ingested 2 servings of ONS (480 kcal) daily. Growth measurements occurred at baseline, days 30, 60, and 120. Parents/caregivers completed a 24-h dietary recall and questionnaires at all timepoints. A total of 279 children participated (ONS+DC: n = 174 enrolled, n = 89 protocol evaluable; DC: n = 105 enrolled, n = 82 protocol evaluable). The primary outcome was change in weight-for-age z -score at 120 d. Results ONS+DC had a significantly higher change in weight-for-age z -score than DC at 120 d (group difference: 0.255 ± 0.058, P < 0.001). Average and change from baseline in weight, weight-for-age, weight-for-height, and BMI-for-age z -scores and percentiles were larger in ONS+DC than DC at all timepoints ( P < 0.05). Change in MUAC-for-age z -score was higher in ONS+DC than DC at 30 and 120 d ( P < 0.05). Change in height-for-age percentile was higher in ONS+DC than DC at 120 d ( P < 0.05). Change in muscle area was larger in ONS+DC than DC over 120 d ( P < 0.05), with no differences in arm fat area or index ( P > 0.05). Conclusions In undernourished United States children, 2 servings of ONS over 120 d improved growth measures more than DC alone. This trial was registered at clinicaltrials.gov as NCT05161000 (https://clinicaltrials.gov/study/NCT05161000?intr=NCT05161000&rank=1; registered 3 December 2021).
Institutions: Abbott Nutrition (United States), Mars (United States)
Language: English
Subfield: Nutrition and Dietetics
Field: Nursing
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $5,000
Funders: Abbott Laboratories, Abbott Nutrition
OpenAlex ID: W7221079904