跳至主要内容
临床试验/NCT06677333
NCT06677333已完成不适用

The Effect of Increasing Dietary Protein on the Gut Microbiota

Louisiana State University Health Sciences Center in New Orleans1 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2023年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
87
试验地点
1
主要终点
Fecal allantoin

研究概览

简要总结

This study will determine the effect of dietary protein not absorbed in the small intestine on the bacteria in the large intestine and the metabolites those bacteria produce when they break down the protein. The three specific goals are:

  1. Determine if increasing dietary protein increases the purine breakdown product, allantoin, as observed in our previous study.
  2. Establish a model to examine the effect of dietary protein on the gut microbiota and metabolites.
  3. Identify gut bacteria and metabolite changes that occur with increased consumption of animal (whey) or plant (pea) protein sources.

详细描述

Healthy male and female participants were recruited following specific inclusion/exclusion criteria. Participants were excluded if they 1) were less than 25 years of age, 2) consumed pre or probiotics in the last week, 3) had taken any antibiotics in the last three months, 4) were taking any prescribed medicines for a chronic disease such as diabetes, hypertension, cancer, anxiety, depression, or GI-related diseases. and 4) had taken any laxatives or antidiarrhea inhibitors in the last week. The study design was pre/post, with each person serving as their own control. Interested participants were randomly assigned to one of two study groups: 50 g whey protein supplement or 50 g pea protein supplement. They were asked to consume the supplement along with their usual dietary intake. Participants were located within the contiguous USA and were sent a fecal collection kit, the protein supplement, and a shaker bottle using overnight shipping. We used the fecal collection kit developed by the Biocollective. A fecal sample was collected before and after the participant consumed the protein supplement daily for seven days. At both time points, the participants were asked to recall the foods they ate during the previous 24 hours using ASA24-2020, provide information on their physical activity (International Physical Activity Questionnaire, IPAQ), and answer questions about the stool sample they collected. The stool sample will be analyzed for the microbes and metabolites present. These will be correlated with the dietary protein they consume.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
25 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •25 years old or older
  • •male or female
  • •located in the contiguous United States

排除标准

  • •Taken any prebiotics in the last week
  • •Taken any probiotics in the last week
  • •Taken any prescription medications other than oral contraceptives
  • •Taken antibiotics sometime in the last three months
  • •Taken any diarrhea inhibitors in the last week
  • •Taken any laxatives in the last week
  • •Taken any dietary supplement(s)
  • •Diagnosed with cancer
  • •Diagnosed with an inflammatory disease of the GI tract, such as irritable bowel disease
  • •Experienced long-haul COVID fatigue
  • •Were physically inactive (<600 METS per week)

研究组 & 干预措施

Pea protein supplement

Experimental

This group of participants will consume 50 g of pea protein supplement daily.

干预措施: Pea protein (Other)

Whey protein supplement

Experimental

This group of participants will consume 50 g of whey protein supplement daily.

干预措施: Whey Protein (Other)

结局指标

主要结局

Fecal allantoin

时间窗: A fecal sample is collected before and after consuming a protein supplement (pea or whey) for seven days.

A cross-sectional study the investigators conducted found that healthy individuals who reported consuming, on average, 150 gms of protein daily had a higher fecal allantoin. This study is a pre/post-randomized controlled trial to confirm that observation. It will determine if consuming 50 gms more protein daily increases fecal allantoin.

次要结局

  • Changes in fecal bacterial species before and after increasing dietary protein intake (pea or whey) by 50 grams for seven days(A fecal sample is collected before and after consuming a protein supplement (pea or whey) for seven days.)
  • Changes in fecal metabolites before and after increasing dietary protein intake (pea or whey) by 50 grams for seven days(A fecal sample is collected before and after consuming a protein supplement (pea or whey) for seven days.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验