Inflammation, Microbiome, Human
Conditions
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.
Interventions
OTHERFermented 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.
Sponsors
University Ghent
Bill and Melinda Gates Foundation
Institut de Recherche en Sciences de la Sante, Burkina Faso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| relative abundance of bacterial and fugal micro-organisms in millet dough and porridge | 2 to 8 weeks | Count of microbial populations |
| Concentration of short chain fatty acid in stool | 0 to 13 weeks | Concentration of C2-C8 fatty acids in stool |
| Number of participant with anemia | 0 to 13 weeks | hemoglobin concentration in grams per deciliter |
| Concentration of Ferritin in plasma | 0- to 13 weeks | Ferritin levels in Plasma |
| concentration of macronutrients in millet dough and porridge | 2 to 8 weeks | Levels of carbohydrates, lipids, protein, dietary fiber and phytates |
Countries
Burkina Faso
Contacts
Primary ContactLaeticia C TOE, MD
Backup ContactLionel O Ouedraogo
Outcome results
None listed