Effect of Fermented Millet Porridge on Gut Microbiota Diversity and Inflammation Markers in Women of Reproductive Age in Rural Burkina Faso: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Gut microbiota diversity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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-
排除标准
- •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
结局指标
主要结局
Gut microbiota diversity
时间窗: 0 to 13 weeks
gut microbiota alpha and beta diversity
Concentration of inflammation markers in blood and stool
时间窗: 0 to 13 weeks
Concentration of IL1-beta, IL 8, IL 6, IL 33, TNF-alpha, lipocalin 2, myeloperoxidase, calprotectin
次要结局
- Concentration of short chain fatty acid in stool(0 to 13 weeks)
- relative abundance of bacterial and fugal micro-organisms in millet dough and porridge(2 to 8 weeks)
- concentration of macronutrients 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)
研究者
Laeticia Celine Toe
Principal Investigator
Institut de Recherche en Sciences de la Sante, Burkina Faso