Fermented Millet Porridge, Gut Microbiota and Inflammation Status in Women

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Fermented Millet Porridge on Gut Microbiota Diversity and Inflammation Markers in Women of Reproductive Age in Rural Burkina Faso: A Pilot Study

Conditions
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Inflammation, Microbiome, Human

Intervention / Treatment
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* Other: Fermented porridge


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fermented porridge<br>this study arm participant will consume fermented millet porridge, daily | Other: Fermented porridge<br>* A millet porridge (fermented or not, depending on group allocation) serving will be provided to participants daily, for consumption. consumption will be directly observed.<br>|
| Active Comparator: Non-fermented porridge<br>this study arm participants will consume non-fermented millet porridge, daily | Other: Fermented porridge<br>* A millet porridge (fermented or not, depending on group allocation) serving will be provided to participants daily, for consumption. consumption will be directly observed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut microbiota diversity | gut microbiota alpha and beta diversity | 0 to 13 weeks | 
| 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 Outcome Measures

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