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OpenTrials
Completed

NCT Number: NCT05752266

Effect of Probiotics on Amino Acid Absorption

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

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Key information

Age range

21 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Verena Tan

Singapore, Sinagpore, 138683

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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
  • Smoking
  • Alcohol consumption

Treatment and study plan

AMILI Probiotic pills

Dietary Supplement

AMILI (AMILI Pte Ltd) will analyze stool samples provided by participants, and assign each participant a type of probiotic pill from the 5 different types of probiotic pills commercially available in AMILI retail store.

Placebo pills

Dietary Supplement

Placebo pills contaning maltodextrin with similar appearance to Probiotic pills will be provided to participants allocated to the Placebo Arm.

Primary outcomes

  1. Change in blood amino acid concentration

    Time frame: 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.

  2. Change in gut microbiota type

    Time frame: 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.

  3. Change in gut microbiota population size

    Time frame: 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.

Secondary outcomes

  1. Change in blood glucose level

    Time frame: 0 to 150 minutes after ingestion of plant protein beverage

    Following ingestion of plant protein beverage, participants will be subjected to drawing of serial blood samples after consuming the plant protein beverage.

    Serial blood samples will be analyzed for glucose profile using mass spectrometry methods.

  2. Change in blood insulin level

    Time frame: 0 to 150 minutes after ingestion of plant protein beverage

    Following ingestion of plant protein beverage, participants will be subjected to drawing of serial blood samples after consuming the plant protein beverage.

    Serial blood samples will be analyzed for insulin profile using mass spectrometry methods.

Sponsors and collaborators

Lead sponsor

Singapore Institute of Technology

Other

Collaborators

  • AMILI Pte. Ltd.

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Mar 2, 2023
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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