Whole Food Fibers for Support of Key Gut Bacteria for Human Health
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Colonic butyrogenic Clostridium clusters IV and XIVa
研究概览
简要总结
The purpose of this supplementation study is to understand how whole food fibers may affect gut microbiota composition and overall health. The investigators will enroll up to 24 people in this study. To be eligible, participants need to be between 18 and 65 years old, have a Body Mass Index of 25 to 35 kg/m², be prediabetic (HbA1c: 5.7 - 6.3), be free of any inflammatory bowel disease or any colon-related disease, be free of wheat allergens or intolerance, and not be pregnant or nursing. If participants have any questions about the criteria, they will ask the investigator consenting them. This is a randomized, cross-over, double-blind, clinical trial (RCT) that will last 12 consecutive weeks in total (4 weeks of treatment A + 4 weeks of washout + 4 weeks of treatment B). The order of the treatments will be randomly assigned before the beginning of the study. If proved right, this study will provide a science-based fiber reason why consumption of whole foods constitutes a better dietary approach than the current practice of adding soluble dietary fiber (inulin) alone to modulate gut microbiota for gut and whole-body health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Overweight or obese, defined as a Body Mass Index (BMI) of 25 to 35 kg/m²
- •Prediabetic (HbA1c: 5.7 - 6.3), though otherwise healthy subjects
- •18-65 years age
排除标准
- •Kidney dysfunction
- •Thyroid dysfunction
- •Liver dysfunction
- •Use of antibiotics in the last four weeks
- •Use of probiotics in the last four weeks
- •Use of prebiotics in the last four weeks
研究组 & 干预措施
Whole food fiber mixture
For a duration of 4 weeks, participants will consume 2 servings per day of a whole-food fiber powder mixture designed by the research team. This intervention period will be followed by a 4-week washout period during which participants will not consume any dietary supplements.
干预措施: Whole food fiber mixture (Dietary Supplement)
Inulin
For a duration of 4 weeks, participants will consume 2 servings per day of a commercially available Inulin. This intervention period will be followed by a 4-week washout period during which participants will not consume any dietary supplements.
干预措施: inulin (Dietary Supplement)
结局指标
主要结局
Colonic butyrogenic Clostridium clusters IV and XIVa
时间窗: Outcomes will be analyzed at the beginning (week 0 and week 8) and end of each supplementation period (week 4 and week 12).
Changes in composition of bacterial taxa belonging to Clostridium clusters IV and XIVa will be assessed following consumption of the whole-food fiber mixture compared with inulin using 16S rRNA gene sequencing of fecal samples.
次要结局
- Blood markers of gut and systemic health effects(Outcomes will be analyzed at the beginning (week 0 and week 8) and end of each supplementation period (week 4 and week 12).)
研究者
CantuJungles
Professor
Purdue University