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

NCT04157413 | Unknown

• 1 other identifier: l9-10-1169
• Study Type: observational
• Target: 172
• Locations: 0 countries
• Sites: N/A

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

Conditions

Stunting

Keywords

amino acid intake; blood amino acid; stunting; linear growth; intestinal permeability; lactulose mannitol ratio

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Linear growth

  December 2019

Study Arms (2)

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.

Eligibility Criteria

• Age: 12 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nia Novita Wirawan: lead
• Indonesia University: collaborator

MeSH Terms

Conditions

Growth Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Badriul S Hegar, Prof

  Indonesia University

  STUDY CHAIR

Central Study Contacts

Nia N Wirawan, MSc.

CONTACT

+628129674654; niawirawan@gmail.com

Umi Fahmida, Dr

CONTACT

+628176060820; ufahmida@seameo-recfon.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 8, 2019
• Study Start: January 2, 2020
• Primary Completion: January 31, 2020
• Study Completion: April 30, 2020
• Last Updated: November 8, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share