Food-based Approach Development to Fulfil Amino Acid Gap by Considering

Status Not yet recruiting

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04157413
Study type	Observational
Source	University of Brawijaya
Contact	Nia N Wirawan, MSc.
Phone	+628129674654
Email	niawirawan@gmail.com
Status	Not yet recruiting
Phase
Start date	January 2, 2020
Completion date	April 30, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03268902` - Early Life Interventions for Childhood Growth and Development In Tanzania	Phase 2/Phase 3
Completed	`NCT03683667` - Protein Plus: Improving Infant Growth Through Diet and Enteric Health	Phase 2/Phase 3
Completed	`NCT01562379` - Complementary Food Supplements for Reducing Childhood Undernutrition	Phase 2/Phase 3
Completed	`NCT03819530` - Child of Urban Poverty Iron Project (CUPIP) - A Pilot Study	N/A
Completed	`NCT03399617` - SPOON: Sustained Program for Improving Nutrition - Guatemala	N/A
Not yet recruiting	`NCT05517395` - The Effectiveness of HBM-based Education Program on Improve Knowledge and Behaviors	N/A
Recruiting	`NCT05100550` - Family-based Health Education Program and Zinc Supplementation for Stunted Mother	N/A
Completed	`NCT05120427` - The Impact of Growth Charts and Nutritional Supplements on Child Growth in Zambia	N/A
Recruiting	`NCT06002438` - Eggs for Gut Health	N/A
Active, not recruiting	`NCT02532816` - Nutrient-Dense Complementary Foods on Catch-up Growth and Nutritional Status of Stunting Children	N/A
Completed	`NCT01553552` - Schistosomiasis Effect on Response to Vaccines, Anaemia and Nutritional Status of Children of Northern Senegal	N/A
Recruiting	`NCT05576207` - BEP Supplementation Research in Bangladesh (JiVitA-BEP-IR)	N/A
Active, not recruiting	`NCT04579328` - Impact of Life-size Growth Charts on Understanding of Stunting	N/A
Completed	`NCT03647553` - The Nash-wo-Numa (Childhood Growth & Development) Study
Completed	`NCT03847662` - Scaling up Small-Scale Food Processing to Promote Food Security Among Women Farmers in Rural Vietnam
Completed	`NCT04640389` - Rural-urban Disparities in the Nutritional Status of Younger Adolescents in Tanzania.
Completed	`NCT00970866` - Efficacy of Lipid-Based Nutrient Supplements (LNS) for Pregnant and Lactating Women and Their Infants	N/A
Active, not recruiting	`NCT02441426` - Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health and Development	N/A
Completed	`NCT05119218` - Gut Microbiota Stunted Children NTT
Completed	`NCT05322655` - PAthogen Transmission and Health Outcome Models of Enteric Disease

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms