Clinical trial NCT04157413: Food-based Approach Development to Fulfil Amino Acid Gap by Considering the Intestinal Permeability of Children
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stunting
Keywords: amino acid intake
blood amino acid
stunting
linear growth
intestinal permeability
lactulose mannitol ratio
Lead sponsor: University of Brawijaya
Sponsor class: OTHER
Collaborators: name: Indonesia University
First posted: 2019-11-08
Enrollment: 172
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Amino acid intake
timeFrame: January - February 2020
measure: Blood amino acid
timeFrame: January - April 2020
measure: Intestinal Permeability
timeFrame: January-April 2020
Secondary outcomes:
Other outcomes:
measure: Linear growth
timeFrame: December 2019
Locations:
Study officials:
affiliation: Indonesia University
name: Badriul S Hegar, Prof
role: STUDY_CHAIR
References: