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临床试验/NCT05752266
NCT05752266已完成不适用

Effect of Probiotics on Amino Acid Absorption

Singapore Institute of Technology2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年3月27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
Change in gut microbiota population size

研究概览

简要总结

The goal of this clinical trial is to test effects of consuming probiotics in healthy adults. The main question it aims to answer is:

• Do consuming probiotics affect a healthy adult's ability to absorb amino acids from plant proteins?

Participants will

  • Consume one dose of probiotic pills per day after meals for two weeks
  • Consume one dose of plant-based plant protein beverage after an overnight fast and collection of one 5 ml fasting blood sample
  • Undergo blood draw of 6 more 5 ml blood samples for the next 3 hours after consuming plant-based protein beverage

详细描述

There is increasing evidence that the gut microbiota contributes to a range of immune, inflammatory, and metabolic responses. Numerous studies have shown that administrating probiotics - strains of bacteria that benefits intestinal function - confer benefits to the host's immune system. Except for soy protein, plant proteins are incomplete proteins lacking in one or more essential amino acids. The incomplete amino acid profile of most plant proteins is compounded by their lower rate of absorption as compared to animal protein. Hence, the investigators aim to investigate the administration of probiotics as a potential strategy to overcome compositional shortcomings of plant proteins by improving the gastrointestinal absorption of plant-based proteins.

The aim of Stage 1 is to formulate a plant-based protein beverage with optimized amino acid profile with consumer acceptance.

Stage 2 of this study will be to conduct a randomized, double-blind, placebo-controlled, crossover trial using the formulation developed in Stage 1, together with probiotics supplementation to evaluate the effect of probiotics on the absorption of amino acids from plant proteins.

The probiotics to be studied will be provided by the Asian Microbiome Library (AMILI) with the plant protein beverage to be developed within SIT. Findings from this mutually beneficial collaborative project with AMILI will pave the way to further understand the role of probiotics in human health, particularly its effect in nutrient absorption of plant protein.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Care Provider)

盲法说明

Masked personnel will be unaware of which arm each participant is allocated to, and what type of probiotics have been assigned to each participant.

入排标准

年龄范围
21 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Be willing and able to comply with study procedures and give written informed consent
  • Self-reported to be healthy
  • Within healthy BMI weight range (18.5-23kg/m2)

排除标准

  • Any chronic medical condition
  • Individuals who were treated for or diagnosed with a gastrointestinal, cardiac, respiratory, circulatory, musculoskeletal, metabolic, immune, autoimmune, haematological, neurological or endocrinological disorder
  • Antibiotic use
  • Prebiotics, probiotics, synbiotics, and/or digestive enzymes use
  • Food allergy/intolerances/avoidances towards eggs, soya, peanuts, tree nuts, crustaceans, and gluten
  • Alcohol consumption

结局指标

主要结局

Change in gut microbiota population size

时间窗: 0 to 6 weeks after start of study

Paricipants will provide a stool sample on each study visit (3 stool samples in total throughout the study). These stool samples given will be analyzed for any changes in type and population size of gut microbes of participants after probiotic intervention and placebo comparator intervention.

Change in blood amino acid concentration

时间窗: 0 to 150 minutes after ingestion of plant protein beverage on each study visit

Following ingestion of plant protein beverage, participants will be subjected to drawing of serial blood samples after consuming the plant protein beverage. These blood samples will be analyzed for amino acid profile using mass spectrometry methods.

Change in gut microbiota type

时间窗: 0 to 6 weeks after start of study

Paricipants will provide a stool sample on each study visit (3 stool samples in total throughout the study). These stool samples given will be analyzed for any changes in type and population size of gut microbes of participants after probiotic intervention and placebo comparator intervention.

次要结局

  • Change in blood glucose level(0 to 150 minutes after ingestion of plant protein beverage)
  • Change in blood insulin level(0 to 150 minutes after ingestion of plant protein beverage)

研究者

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

Verena Tan Ming Hui

Associate Professor

Singapore Institute of Technology

研究点 (2)

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