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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05299970
Other study ID # NUT_IRSS_0001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 21, 2022
Est. completion date July 31, 2024

Study information

Verified date October 2023
Source Institut de Recherche en Sciences de la Sante, Burkina Faso
Contact Laeticia C TOE, MD
Phone 0022671007272
Email cellaety@yahoo.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Maternal undernutrition concerns 10-19% of women of reproductive age globally, the vast majority of which live in sub Saharan Africa and south Asia. Recommendations for nutritional interventions to tackle the problem range from per-pregnancy supplementation to upstream interventions targeting women of reproductive age before conception. To render the latter interventions cost-effective and sustainable, experts recommend to focus on food processing that leads to an enhanced nutrient content. One such method, which has been known and practiced for centuries in diverse societies, is fermentation. Traditionally fermented foods are diverse, widespread and highly appreciated in Burkina Faso. The present study aims to investigate the effect of fermented millet porridge on gut microbiota diversity, stool short chain fatty acid concentration and inflammation markers level in women of reproductive age living in rural Burkina Faso.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date July 31, 2024
Est. primary completion date January 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 49 Years
Eligibility Inclusion Criteria: Participant are - 18 to 49 years old - Resident in the study area and do not plan to move within 5 months following the start of the study - Are not on antibiotic treatment on inclusion and have not been in the previous 3 weeks. - Do not suffer from any pathology that could interfere with their diet. - Have no known allergy to pearl millet or its derivatives - Agree to sign a consent to participate in the study- Exclusion Criteria: - Women under 18 or over 49 - Women not consuming pearl millet porridge due to allergy or food preference - Women planning to move from the study area within 5 months of the start of the study - Women with serious illnesses that may interfere with their diet - Women on antibiotic treatment or at the time of inclusion or having been in the previous 3 weeks. - In addition, women who will benefit from antibiotic therapy during the study will be excluded from the analysis

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Fermented porridge
A millet porridge (fermented or not, depending on group allocation) serving will be provided to participants daily, for consumption. consumption will be directly observed.

Locations

Country Name City State
Burkina Faso IRSS-DRO Bobo-Dioulasso Houet, Région Des hauts-Bassins

Sponsors (3)

Lead Sponsor Collaborator
Institut de Recherche en Sciences de la Sante, Burkina Faso Bill and Melinda Gates Foundation, University Ghent

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gut microbiota diversity gut microbiota alpha and beta diversity 0 to 13 weeks
Primary Concentration of inflammation markers in blood and stool Concentration of IL1-beta, IL 8, IL 6, IL 33, TNF-alpha, lipocalin 2, myeloperoxidase, calprotectin 0 to 13 weeks
Secondary Concentration of short chain fatty acid in stool Concentration of C2-C8 fatty acids in stool 0 to 13 weeks
Secondary concentration of macronutrients in millet dough and porridge Levels of carbohydrates, lipids, protein, dietary fiber and phytates 2 to 8 weeks
Secondary relative abundance of bacterial and fugal micro-organisms in millet dough and porridge Count of microbial populations 2 to 8 weeks
Secondary Concentration of Ferritin in plasma Ferritin levels in Plasma 0- to 13 weeks
Secondary Number of participant with anemia hemoglobin concentration in grams per deciliter 0 to 13 weeks
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