Effect of Probiotics on Amino Acid Absorption

NCT05752266 | Completed

• 1 other identifier: 2022180
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Protein Digestion; Gastrointestinal Microbiome

Outcome Measures

Primary Outcomes (3)

• Change in blood amino acid concentration

  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.

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

• Change in gut microbiota type

  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.

  0 to 6 weeks after start of study

• Change in gut microbiota population size

  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.

  0 to 6 weeks after start of study

Secondary Outcomes (2)

• 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

Study Arms (2)

Probiotic Arm

EXPERIMENTAL

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

Dietary Supplement: AMILI Probiotic pills

Placebo Arm

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo pills

Interventions

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.

Probiotic Arm

Placebo pills DIETARY_SUPPLEMENT

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

Placebo Arm

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore Institute of Technology: lead
• AMILI Pte. Ltd.: collaborator

Study Sites (1)

Verena Tan

Singapore, Sinagpore, 138683, Singapore

Location

Related Publications (1)

• 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.

  PMID: 32358640 BACKGROUND

Study Officials

• Verena Tan, M.Nutr.Diet

  +65 9172 4062

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Masked personnel will be unaware of which arm each participant is allocated to, and what type of probiotics have been assigned to each participant.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized, placebo-controlled, crossover trial

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 2, 2023
• Study Start: March 27, 2023
• Primary Completion: July 14, 2023
• Study Completion: September 30, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Locations

SG (1)