Effect of Probiotics on Amino Acid Absorption

Sponsor
Singapore Institute of Technology (Other)
Overall Status
Recruiting
CT.gov ID
NCT05752266
Collaborator
AMILI Pte. Ltd. (Other)
20
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13.3
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: AMILI Probiotic pills
  • Dietary Supplement: Placebo pills
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Randomized, placebo-controlled, crossover trialRandomized, placebo-controlled, crossover trial
Masking:
Double (Participant, Care Provider)
Masking Description:
Masked personnel will be unaware of which arm each participant is allocated to, and what type of probiotics have been assigned to each participant.
Primary Purpose:
Basic Science
Official Title:
Effect of Probiotics on Amino Acid Absorption
Actual Study Start Date :
Jan 27, 2023
Anticipated Primary Completion Date :
Jun 27, 2023
Anticipated Study Completion Date :
Mar 6, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Probiotic Arm

Participants allocated to PRO arm will be administered personalized probiotic pills.

Dietary Supplement: AMILI Probiotic pills
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 Comparator: Placebo Arm

Participants allocated to PRO arm will be administered maltodextrin placebo pills similar in appearance to probiotic pills.

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

Outcome Measures

Primary Outcome Measures

  1. Change in blood amino acid concentration [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 [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 [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 Outcome Measures

  1. Change in blood glucose level [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Verena Tan Singapore Sinagpore Singapore 138683

Sponsors and Collaborators

  • Singapore Institute of Technology
  • AMILI Pte. Ltd.

Investigators

  • Principal Investigator: Verena Tan, M.Nutr.Diet, +65 9172 4062

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Verena Tan Min Hui, Associate Professor, Singapore Institute of Technology
ClinicalTrials.gov Identifier:
NCT05752266
Other Study ID Numbers:
  • 2022180
First Posted:
Mar 2, 2023
Last Update Posted:
Mar 2, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 2, 2023