Impact of Fermented Pulses on Inflammation and the Gut Microbiota
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Change in inflammation levels from baseline and between interventions
研究概览
简要总结
The goal of this clinical trial is to learn about the effects of consuming fermented pulses (certain types of legumes like chickpeas or lentils) in healthy people. The main questions it aims to answer are:
- How does consuming the fermented foods impact the gut microbiome?
- Does this interaction between the fermented foods and the gut microbiome affect inflammation?
Participants will be asked to consume two sets of prepared meals, one containing unfermented pulses, the other containing fermented pulses.
Researchers will compare the gut microbiome and inflammation between these two diets.
详细描述
The rationale for the research is that fermentation of pulses can reduce the concentration of compounds that suppress butyrate producing bacteria and butyrate production. This will in turn boost butyrate production during consumption of these fermented pulses relative to that in unfermented pulses. This in turn will lead to lower inflammation in people consuming fermented pulses. To best study this question the investigators will utilize a cross-over design trial where participants will consume daily meals containing either fermented or unfermented pulses (chickpeas), followed by a washout period and then a period of consuming the other type of pulse. The investigators hypothesize that those consuming the fermented pulses will experience a significant decrease in inflammatory markers driven by increased butyrate production by gut bacteria.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Subjects will receive both interventions labeled only as 1 or 2. The study team assessing inflammation and microbiome will not know the identity of intervention 1 or 2. The preparer of the meals will also conduct dietary recall interviews with subjects and will know the identities of the interventions.
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
- 是
入选标准
- •Healthy adults
排除标准
- •Taken antibiotics within the past month
- •Taking any medication for the management of diabetes or obesity
- •Are pregnant
- •BMI > 24.9
- •Allergies to pulses or any other meal components
研究组 & 干预措施
Unfermented Chickpea
干预措施: Unfermented chickpea (Other)
Fermented Chickpea
干预措施: Fermented chickpea (Other)
结局指标
主要结局
Change in inflammation levels from baseline and between interventions
时间窗: At 2 weeks (baseline), 4 weeks (after first intervention), 8 weeks (after second intervention)
Measured in blood (IL-1β, IL-6, IL-10, IL-12, IFN-γ, TNF-α) and in feces (NGAL, calprotectin)
次要结局
- Change in gut microbiome composition from baseline and between interventions(At 2 weeks (baseline), 4 weeks (after first intervention), 8 weeks (after second intervention))
- Change in fecal short chain fatty acids from baseline and between interventions(At 2 weeks (baseline), 4 weeks (after first intervention), 8 weeks (after second intervention))
研究者
Darrell W. Cockburn, Ph.D.
Assistant Professor
Penn State University