NCT04157413

Food-based Approach Development to Fulfil Amino Acid Gap by Considering the Intestinal Permeability of Children

The Role of Essential Amino Acid Intake and Intestinal Permeability on Amino Acid Blood Profile and Linear Growth Among Indonesian Children 12-24 Months Living in an Agricultural Area: A Basis for a Food Based Intervention

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 172 (estimated)
• Sponsor: Nia Novita Wirawan · Academic / Other
• Sex: All
• Age: 12 Months – 24 Months
• Healthy volunteers: Accepted

Summary

This study will be comprised of 2 phases. Phase 1 study is a comparative cross-sectional study which will be conducted among children aged 12-24 months living in agricultural area. A total of 172 healthy children consisted of 86 stunted children (Length for age z-score \<-2 Standard deviation) and 86 non-stunted children (Length for age z-score ≥0.5 Standard Deviation) will be recruited. Dietary intake, urine and dried blood spot from finger prick will be collected to assess amino acid intake, intestinal permeability and essential blood amino acid respectively. Qualitative study i.e. focus group discussion (FGD) and market survey will also be implemented. According to the result of phase 1 study, 2 types of food-based approaches will be developed, namely Complementary food recommendations (CFR) and Food multi-mix formula

Detailed description

Phase 1 study will recruit a total of 172 healthy children who are matched by sex and age. Aside of being stunted, children must have normal weight for length z-score (not wasted or overweight). Data collection will be performed as follows: 1. Dietary intake of the children will be collected by 9 days Estimated Food Record by visiting the respondents house 2. Urine will be collected once to measure intestinal permeability profile using Lactulose Mannitol ratio indicator. 3. Dried blood spot from finger prick will be collected to essential blood amino acid. To collect information on locally available and culturally accepted protein rich food sources, series of focus group discussion (FGD) and market survey will also be implemented. Food-based approaches will be developed according to the information attained from phase 1 study. Problem nutrients that are identified from dietary assessment will be fulfilled through optimization of locally available food by using linear programming approach. Problem nutrients that are not able to be fulfilled by CFR will be use as a basis to develop a Food multi-mix (FMM) formula. Data of intestinal permeability profile will be used to add other locally available food in FMM that are potential to improve intestinal permeability.

Conditions

• Stunting

Timeline

• Start date: 2020-01-02
• Primary completion: 2020-01-31
• Completion: 2020-04-30
• First posted: 2019-11-08
• Last updated: 2019-11-08