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临床试验/NCT05885750
NCT05885750已完成不适用

The Impact of Plant-Based Protein-rich Food Products With Varying Degree of Processing on the Human Gut Microbiome Composition and Human Metabolome

University of Turku2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2023年4月5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
38
试验地点
2
主要终点
Metabolomics

研究概览

简要总结

It is observed that replacing meat with protein-rich plant-based food products are associated with lower mortality and obesity prevention. Sources of plant proteins typically undergo several processing and refinement procedures to improve the taste and digestibility of plant-based food products. These procedures alter the chemical composition, which can impact the nutritional quality of the processed food. It is not known what is the impact of processed products on human metabolism and intestinal microbiota. Therefore, the impact of a set of plant-based protein-rich food products with varying degree of processing on the composition and function of human gut microbiome and metabolism will be assessed in a clinical intervention

详细描述

Plant-based diets are known to have beneficial effects on both the environment and human health. Replacing animal protein with plant protein reduces overall mortality risk, and replacing meat with legumes and other sources of plant protein can lower the risk of chronic diseases such as type 2 diabetes and cardiovascular disease. However, the benefits of plant protein products is not evident. In order to make plant protein products more palatable and digestible, plant raw materials may go through several processing and refinement procedures. Typically, during these phases, carbohydrate fractions (e.g. dietary fiber) are removed from the plant material, which results in the loss of micronutrients as well as secondary plant metabolites with potentially health effects (e.g. polyphenolic compounds). Salt and various fats are added to some products, which can reduce the nutritional quality of the product. Subsequently, not all plant-based protein-rich foods are automatically healthy as there may be significant differences in the nutritional quality of the processed products, depending on the food processing utilized. Only little research information is available on the effects of processed plant protein products on human metabolism and intestinal microbiota. Therefore, this cross-over clinical intervention will be conducted with 38 healthy participants to investigate the impact of a set of plant-based protein-rich food products with varying degree of processing on the composition and function of human gut microbiome and metabolism will be assessed in a clinical intervention.

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
None

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

入选标准

  • Willingness to participate
  • 18-65-years olf
  • BMI 18.5-27 kg/m2

排除标准

  • Chronic disease with continuous medication
  • Antibiotic use in the past 6 months
  • Active smoker
  • Gluten-free or vegan diet
  • Pregnancy, lactation
  • Abnormal thyroid, liver, or kidney function
  • Low hemoglobin

研究组 & 干预措施

Diet 1

Experimental

Unprocessed or minimally processed plant-based protein-rich food products

干预措施: Unprocessed (Behavioral)

Diet 2

Experimental

Mildly processed plant-based protein-rich food products

干预措施: Mildly processed (Behavioral)

Diet 3

Experimental

Heavily refined plant-based protein-rich food products

干预措施: Heavily refined (Behavioral)

结局指标

主要结局

Metabolomics

时间窗: one week between the start and end of each intervention

The changes in metabolism evoked by the interventions

Transcriptomics

时间窗: one week between the start and end of each intervention

The changes in endogenous gene expression on RNA level

Inflammation status by high-sensitive CRP

时间窗: one week between the start and end of each intervention

The changes in high-sensitive CRP by clinical biochemistry analysis

Metagenomics

时间窗: one week between the start and end of each intervention

The alterations in the composition of gut microbiota

Inflammation status by inflammatory cytokines

时间窗: one week between the start and end of each intervention

The changes in inflammatory cytokines

次要结局

  • Lipid homeostasis(one week between the start and end of each intervention)
  • Body weight(five weeks (baseline and at the end of the complete study / after three interventions and 2 wash-outs))
  • Glucose homeostasis(one week between the start and end of each intervention)

研究者

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

Marko Kalliomäki, MD

Clinical Professor

University of Turku

研究点 (2)

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