Impact of traditional fermented rice-water on maternal nutrition in Odisha, India
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Documentation of the impact of the fermented-rice (Torani) intake on nutrition, gut and vaginal microbiota, gut microbiome, and inflammatory markers in reproductive-age women
研究概览
简要总结
We propose todocument the effect of traditional fermented rice-water (Pakhala/Torani) on gut and vaginal microbiome, nutritional profile, and inflammatory markers in reproductive age women in Odisha (India) as aneffort to address the maternal nutritional problem. The Torani is expected to have multidimensional effects includingnutrition (micro-/macro-nutrients), gut microbiome, gut and systemicinflammation, and source of short-chain fatty acids (SCFAs) for energy. To explore the characterization of the microbiota,SCFAs, nutrients, and volatile compounds in Toranisamples prepared using different rice types over varying fermentation periodsand the effect on gut microbiota and nutrition and inflammatory markers inhealthy adults for documenting dose effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 25.00 Year(s)（—）
- 性别
- Female
入选标准
- •Non-pregnant participants: women aged >18 years, staying in the locality and expected to stay for next 6-8 months; access to the phone for contact; not suffering from any major systemic disease, ambulatory
- •Pregnant participants: pregnant women aged >18 years, first trimester pregnancy, no high risk factors or bad obstetric history, staying in the locality and expected to stay for next 6-8 months; access to phone for contact; not suffering from any major systemic disease, ambulatory.
排除标准
- •Refusal for consent, inability to follow the schedule, unwilling to accept or not feasible to consume the fermented rice-water as per schedule.
结局指标
主要结局
Documentation of the impact of the fermented-rice (Torani) intake on nutrition, gut and vaginal microbiota, gut microbiome, and inflammatory markers in reproductive-age women
时间窗: 0, 1, 2, 4, and 6 months
次要结局
- To document effect of the fermented-rice (Torani) intake on inflammatory markers in reproductive-age women(0, 1, 2, 4, and 6 months)