Effect of Pea Fiber Supplementation on the Gut Microbiota and Host Metabolome and Proteome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Changes in urine proteomes and metabolomes as assessed by liquid chromatography
研究概览
简要总结
All subjects will complete a 49-day, multi-phase feeding study to evaluate the effect of pea fiber supplementation on gut community structure and features of host biological state (plasma proteome/ metabolome). Subjects will be asked to continue to consume their habitual diet (free diet phase) for 4 days prior to being provided with a diet high in saturated fat (HiSF) and low in fruits and vegetables (LoFV) in the form of packed-out meals and snacks to consume for the following 45 days. Ten days after starting to consume the HiSF-LoFV diet, subjects will supplement their diet with pea fiber for a total of 21 days; the energy contribution from the HiSF-LoFV diet will be reduced accordingly to maintain energy needs during this time. After completing the pea fiber supplementation phase of the study subjects will revert back to consuming the HiSF-LoFV only diet for the final 14 days. Stool, urine and blood will be sampled periodically throughout.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 25.0-35.0 kg/m²
- •Presence of B. vulgatus and B. thetaiotaomicron each at greater than 0.01% relative abundance
排除标准
- •Previous bariatric surgery
- •Significant organ system dysfunction (e.g. diabetes, severe pulmonary, kidney, liver, or cardiovascular disease)
- •Cancer or cancer that has been in remission for less than 5 years
- •Major psychiatric illness
- •Inflammatory gastrointestinal disease
- •Pregnant or lactating women
- •Use of medications that are known to affect the study outcome measures
- •Use of medications or supplements known to affect composition of the gut microbiota within the last 30 days (e.g. antibiotics)
- •Bowel movements less than 3 times per week
- •Vegans, vegetarians, and those with allergies, aversions, or sensitivities to foods provided in the study
- •Persons that are not able to grant voluntary informed consent
- •Persons who are unable or unwilling to follow the study protocol or who the research team deems not an appropriate candidate for the study.
结局指标
主要结局
Changes in urine proteomes and metabolomes as assessed by liquid chromatography
时间窗: Daily or every other day first-morning urine samples will be collected from day 1 to day 49 of the study
First morning urine samples will be collected periodically throughout the study
Changes in plasma proteomes and metabolomes as assessed by liquid chromatography
时间窗: Fasted blood draws will be collected on days 1, 14, 21, 28, 35, and 49 of the study
fasting blood draws will be collected periodically throughout the study
Changes to the gut microbiota as assessed by established culture independent methods, as well as LC-QTOF Mass-Spectometry (MS) and LC-QQQ MS and GC-MS
时间窗: stool samples will be collected from the screening visit through the final day of the 49-day intervention
Frequent stool samples will be collected throughout the entire study
Change in plasma lipid profile as assessed by the complete metabolic panel and lipid panel.
时间窗: At screening, day 14, day 35, and day 49
Blood will be drawn for the complete metabolic panel and lipid panel
Change in hemoglobin A1c (HbA1c) in response to the dietary intervention
时间窗: At screening, day 14, day 35, and day 49
Blood will be drawn for the HbA1c
次要结局
未报告次要终点