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临床试验/NCT05619939
NCT05619939已完成不适用

Determining the Effect of Dietary Protein Source on Intestinal Health

Stony Brook University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年1月18日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Montrose

Principal Investigator

Stony Brook University

研究点 (2)

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