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

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

Study Overview

• Status: Unknown
• Conditions: Stunting

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 Type: Observational
• Enrollment (Anticipated): 172

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 2 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Target population of this study are children 12-24 months living in rural agricultural area in Kabupaten Malang. Kecamatan will be chosen based on the high prevalence of stunting and having potentials of protein food source to be optimized. Sample of the study are children living in selected villages in the period of 2019-2020 who fulfill the inclusion criteria.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Stunted Group; A comparative cross sectional study will compare stunted group and non-stunted group on amino acid intake, blood amino acid and intestinal permeability. Stunted group is defined as children who have LAZ <-2 SD
Non-stunted Group; Non-stunted group will be those with LAZ >= 0.5 SD matching by age and sex with stunted group. Other criteria will be similar. No Intervention will be given to the groups in this proposed protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amino acid intake	Amino acid intake will be assessed by estimated food record	January - February 2020
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
Intestinal Permeability	Intestinal permeability will be measured from urine and will be analyzed using HPLC	January-April 2020

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Linear growth	Linear growth in terms of length will be measured using anthropometric measurements to define stunted and non-stunted group.	December 2019

Collaborators and Investigators

• Sponsor: Nia Novita Wirawan
• Collaborators: Indonesia University
• Investigators: Study Chair: Badriul S Hegar, Prof, Indonesia University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 2, 2020
• Primary Completion (ANTICIPATED): January 31, 2020
• Study Completion (ANTICIPATED): April 30, 2020

Study Registration Dates

• First Submitted: November 6, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (ACTUAL): November 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 8, 2019
• Last Update Submitted That Met QC Criteria: November 6, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: stunting; intestinal permeability; linear growth; amino acid intake; blood amino acid; lactulose mannitol ratio
• Additional Relevant MeSH Terms: Pathologic Processes; Growth Disorders
• Other Study ID Numbers: l9-10-1169

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: I will not share the IPD of the subject participated due to consent issue

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No