Fermented Millet Porridge, Gut Microbiota and Inflammation Status in Women

NCT05299970 | Unknown

• 1 other identifier: NUT_IRSS_0001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Microbiome, Human

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Concentration of short chain fatty acid in stool

  0 to 13 weeks

• concentration of macronutrients in millet dough and porridge

  2 to 8 weeks

• relative abundance of bacterial and fugal micro-organisms in millet dough and porridge

  2 to 8 weeks

• Concentration of Ferritin in plasma

  0- to 13 weeks

• Number of participant with anemia

  0 to 13 weeks

Study Arms (2)

fermented porridge

EXPERIMENTAL

this study arm participant will consume fermented millet porridge, daily

Other: Fermented porridge

Non-fermented porridge

ACTIVE COMPARATOR

this study arm participants will consume non-fermented millet porridge, daily

Other: Fermented porridge

Interventions

Fermented porridge OTHER

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

Non-fermented porridge; fermented porridge

Eligibility Criteria

• Age: 18 Years - 49 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant are
• to 49 years old
• Resident in the study area and do not plan to move within 5 months following the start of the study
• 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-

You may not qualify if:

• 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
• In addition, women who will benefit from antibiotic therapy during the study will be excluded from the analysis

Sponsors & Collaborators

• Institut de Recherche en Sciences de la Sante, Burkina Faso: lead
• University Ghent: collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

IRSS-DRO

Bobo-Dioulasso, Houet, Région Des hauts-Bassins, 01 BP 545, Burkina Faso

RECRUITING

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laeticia C TOE

  IRSS-DRO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laeticia C TOE, MD

CONTACT

0022671007272; cellaety@yahoo.fr

Lionel O Ouedraogo

CONTACT

0022670530583; lionel.olivier.ouedraogo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 20, 2022
• First Posted: March 29, 2022
• Study Start: March 21, 2022
• Primary Completion: January 30, 2024
• Study Completion: July 31, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR, ANALYTIC CODE

Locations

BU (1)