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

Stunting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04157413
• Other study ID #: l9-10-1169
• Status: Not yet recruiting
• Start date: January 2, 2020
• Est. completion date: April 30, 2020

Study information

• Verified date: November 2019
• Source: University of Brawijaya
• Contact: Nia N Wirawan, MSc.
• Phone: +628129674654
• Email: niawirawan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 172
• Est. completion date: April 30, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Growth Disorders
• Stunting

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nia Novita Wirawan	Indonesia University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Linear growth	Linear growth in terms of length will be measured using anthropometric measurements to define stunted and non-stunted group.	December 2019
Primary	Amino acid intake	Amino acid intake will be assessed by estimated food record	January - February 2020
Primary	Blood amino acid	Essential blood amino acid will be measured from finger prick dried blood spot and will be analyzed using LC-MS/MS	January - April 2020
Primary	Intestinal Permeability	Intestinal permeability will be measured from urine and will be analyzed using HPLC	January-April 2020