NCT03895151

Association Between Intakes of Protein, Calcium and Milk With Gene Expression and Linear Growth of School Aged Children

Completed NA Last updated 3 December 2019

What this trial tests

NA trial testing Milk supplementation in Nutritional Stunting in 150 participants. Completed in 30 June 2019.

Timeline

24 January 2018

Primary endpoint
15 June 2019

30 June 2019

Quick facts

Lead sponsor	SEAMEO Regional Centre for Food and Nutrition
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	150
Start date	24 January 2018
Primary completion	15 June 2019
Estimated completion	30 June 2019
Sites	1 location across Indonesia

Drugs / interventions tested

• Milk supplementation
• Food Based Recommendation (FBR) nutrition education

Conditions studied

• Nutritional Stunting — all drugs for Nutritional Stunting →
• Nutritional Anemia — all drugs for Nutritional Anemia →
• Nutritional Deficiency — all drugs for Nutritional Deficiency →
• Nutrigenetic — all drugs for Nutrigenetic →

Sponsor

SEAMEO Regional Centre for Food and Nutrition

Who can join

Adults 8 to 10, any sex, with Nutritional Stunting or Nutritional Anemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Protein is one type of nutrients known as the cause of stunting in developing countries since the mid-1970s (1) but then less attention on protein intake with the assumption that protein intake is sufficient. Compilation of published and non-published dietary intake research among Indonesian children aged 3-12 years (2), 0-18 years old (3) and 1-3 years old (3) found that protein intake among Indonesian children was sufficient (4). This finding is also confirmed by some other studies in 6 low-income countries and lead to the conclusion that growth restriction is not due to protein deficiency (5). Since then, micronutrient received main attention for the past 4 decades (1) to improve the health and survival of young children in developing countries. Issues on the need to re-examined protein recently emerge after the paper of Semba (1,6) regarding the low circulating amino acid among stunted children. It was hypothesized that the correlation between the low level of circulating amino acid with linear growth was through the mechanism of rapamycin complex C1 (mTORC1) and general control nonderepressible 2 (GCN2) pathway that contributes in the synthesis of sphingolipids and glycerophospholipids (6). However, the mechanism on how amino acid link to linear growth remains unclear.

Fortification among Asian children revealed that only milk as food vehicles reported a significant effect on linear growth (2). It is likely that the effect on linear growth is influenced not only on micronutrient content of the fortified foods but also on protein and amino acid profiles of milk as the food vehicle.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Growth, Dietary Intake, and Vitamin D Receptor (VDR) Promoter Genotype in Indonesian School-Age Children.
   Angelin TC, Bardosono S, Shinta D, Fahmida U. · · 2021 · cited 5× · PMID 34578782 · DOI 10.3390/nu13092904
2. Coevolution of Human Diet and Gut Microbiome: Implications for Nutrigenomics and Cross-Population Health.
   Sandra F, Scania AE, Dewi NM, Ranggaini D, et al · · 2026 · PMID 42051940 · DOI 10.1155/ijm/5597426