Fermented Millet Porridge, Gut Microbiota and Inflammation Status in Women

Not Applicable

Recruiting

• Conditions: Microbiome, Human; Inflammation
• Interventions: Other: Fermented porridge

• Registration Number: NCT05299970
• Lead Sponsor: Institut de Recherche en Sciences de la Sante, Burkina Faso

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-20
• Study First Submitted QC: 2022-03-20
• Study Start: 2022-03-21
• Study First Posted: 2022-03-29
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-23
• Primary Completion: 2024-01-30
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fermented porridge	Fermented porridge	this study arm participant will consume fermented millet porridge, daily
Non-fermented porridge	Fermented porridge	this study arm participants will consume non-fermented millet porridge, daily

Primary Outcome Measures

Name	Time	Method
Gut microbiota diversity	0 to 13 weeks	gut microbiota alpha and beta diversity
Concentration of inflammation markers in blood and stool	0 to 13 weeks	Concentration of IL1-beta, IL 8, IL 6, IL 33, TNF-alpha, lipocalin 2, myeloperoxidase, calprotectin

Secondary Outcome Measures

Name	Time	Method
Concentration of short chain fatty acid in stool	0 to 13 weeks	Concentration of C2-C8 fatty acids in stool
relative abundance of bacterial and fugal micro-organisms in millet dough and porridge	2 to 8 weeks	Count of microbial populations
concentration of macronutrients in millet dough and porridge	2 to 8 weeks	Levels of carbohydrates, lipids, protein, dietary fiber and phytates
Concentration of Ferritin in plasma	0- to 13 weeks	Ferritin levels in Plasma
Number of participant with anemia	0 to 13 weeks	hemoglobin concentration in grams per deciliter

Trial Locations

Locations (1)

IRSS-DRO; 🇧🇫 Bobo-Dioulasso, Houet, Région Des hauts-Bassins, Burkina Faso