Effect of Probiotics on Amino Acid Absorption

NCT ID: NCT05752266

Last Updated: 2024-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-27
• Study Completion Date: 2024-09-30

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

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.

Conditions

Protein Digestion; Gastrointestinal Microbiome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Probiotic Arm

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

Group Type: EXPERIMENTAL

AMILI Probiotic pills

Intervention Type: 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 Arm

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

Group Type: PLACEBO_COMPARATOR

Placebo pills

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo pills

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AMILI Pte. Ltd.

UNKNOWN

Sponsor Role: collaborator

Singapore Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Verena Tan Ming Hui

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Verena Tan, M.Nutr.Diet

Role: PRINCIPAL_INVESTIGATOR

+65 9172 4062

Locations

Verena Tan

Singapore, Sinagpore, Singapore

Countries

Singapore

References

Jager R, Zaragoza J, Purpura M, Iametti S, Marengo M, Tinsley GM, Anzalone AJ, Oliver JM, Fiore W, Biffi A, Urbina S, Taylor L. Probiotic Administration Increases Amino Acid Absorption from Plant Protein: a Placebo-Controlled, Randomized, Double-Blind, Multicenter, Crossover Study. Probiotics Antimicrob Proteins. 2020 Dec;12(4):1330-1339. doi: 10.1007/s12602-020-09656-5.

Reference Type: BACKGROUND

PMID: 32358640 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2022180

Identifier Type: -

Identifier Source: org_study_id