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

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Microbiome; Protein Digestion
• Intervention / Treatment: Dietary supplement: AMILI Probiotic pills; Dietary supplement: Placebo pills

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Sinagpore
    • Singapore, Sinagpore, Singapore, 138683
      • Verena Tan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood glucose level	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.	0 to 150 minutes after ingestion of plant protein beverage
Change in blood insulin level	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.	0 to 150 minutes after ingestion of plant protein beverage

Collaborators and Investigators

• Sponsor: Singapore Institute of Technology
• Collaborators: AMILI Pte. Ltd.
• Investigators: Principal Investigator: Verena Tan, M.Nutr.Diet, +65 9172 4062

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2023
• Primary Completion (Actual): July 14, 2023
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2022180

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No