Determining the Effect of Dietary Protein Source on Intestinal Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Fecal metabolome
研究概览
简要总结
The gastrointestinal (GI) tract is a central hub for human health given its essential role in nutrient absorption, waste production and immunity. Diet is a major contributor to gut health including affecting the incidence and severity of GI disease. This is mediated, at least in part, by the presence of microbiota, a highly diet-dependent biome. In fact, dietary changes are capable of altering bacterial populations and/or microbial metabolism, which in turn, controls the type and abundance of small molecules being produced in the gut, many of which can exert biological effects. Several lines of evidence suggest that dietary protein in particular, can impact gut health. Therefore, this trial will test whether dietary protein type differentially impacts gut function in humans by carrying out a single-blinded randomized cross-over controlled feeding study in healthy individuals. Subjects will be provided with an individualized very low protein diet augmented with pea- or egg white-derived protein supplements, as their major protein source. The impact of consuming pea vs. egg white protein on 1) the fecal metabolome, 2) gut barrier function and 3) gastrointestinal symptoms will be determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Subjects will be blinded as to which protein type they are receiving.
入排标准
- 年龄范围
- 18 Years 至 30 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI of 18-29.9
排除标准
- •Those with a history of significant illness including diabetes, renal, liver or cardiovascular disease, malnutrition, GI disease (including IBS, IBD, chronic constipation or diarrhea), mental illness (i.e. depression, bipolar disorder)
- •Those adhering to a vegan diet or vegetarian diet exclusive of eggs
- •Those having taken probiotics or antibiotics within 1 month of starting the study
- •Those who are pregnant or plan to become pregnant
结局指标
主要结局
Fecal metabolome
时间窗: This analysis will be carried out at baseline and the end of each treatment period, entailing 4 measurements over an approximately 36 day period
Mass-spectrometry based analysis of the relative abundance of metabolites will be carried out on feces.
Intestinal permeability
时间窗: This analysis will be carried out at baseline and the end of each treatment period, entailing 4 measurements over an approximately 36 day period
Subjects will undergo lactulose-mannitol test to inform on gut permeability
次要结局
- Adherence to study diets(Daily over two, 10-day periods)
- Amount of study diets consumed(Daily over two, 10-day periods)
研究者
David Montrose
Principal Investigator
Stony Brook University
