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

• Conditions: Stunting

• Registration Number: NCT04157413
• Lead Sponsor: Nia Novita Wirawan

Brief 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.

Study Timeline

• Status Verified: 2019-11
• Study First Submitted: 2019-11-06
• Study First Submitted QC: 2019-11-06
• Last Update Submitted: 2019-11-06
• Study First Posted: 2019-11-08
• Last Update Posted: 2019-11-08
• Study Start: 2020-01-02
• Primary Completion: 2020-01-31
• Study Completion: 2020-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

1. Stunting group is defined as length for age Z-score (LAZ) <-2.0 SD and non-stunting group as LAZ ≥-0.5 SD
2. Normal weight for length Z-score (WLZ ≥-2 SD to ≤+1 SD)
3. Group matching by age, gender
4. Singleton
5. Full term gestation
6. Normal birth weight
7. Living with mother
8. Not suffered from diarrhea at least in the last 1 month (as reported by the mothers)
9. Not suffering from fever during assessment (as measured by the health staff)
10. Not born from diabetic mothers (as reported by the mothers)

Exclusion Criteria

1. Drink Ultra High Temperature (UHT) milk at least 15 days before urine collection
2. Taking any medication.
3. Had taken non-steroidal anti-inflammatory drugs within two weeks of the study,
4. Taken antibiotics within 4 weeks of the study,
5. Unable to drink the sugar solution
6. Refuse to participate until completion of the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amino acid intake	January - February 2020	Amino acid intake will be assessed by estimated food record
Blood amino acid	January - April 2020	Essential blood amino acid will be measured from finger prick dried blood spot and will be analyzed using LC-MS/MS
Intestinal Permeability	January-April 2020	Intestinal permeability will be measured from urine and will be analyzed using HPLC