Effect of Probiotics on Amino Acid Absorption

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Probiotics on Amino Acid Absorption

Conditions
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Protein Digestion, Gastrointestinal Microbiome

Intervention / Treatment
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* Dietary Supplement: AMILI Probiotic pills
* Dietary Supplement: Placebo pills


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, placebo-controlled, crossover trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic Arm<br>Participants allocated to PRO arm will be administered personalized probiotic pills. | Dietary Supplement: AMILI Probiotic pills<br>* 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.<br>|
| Placebo Comparator: Placebo Arm<br>Participants allocated to PRO arm will be administered maltodextrin placebo pills similar in appearance to probiotic pills. | Dietary Supplement: Placebo pills<br>* Placebo pills contaning maltodextrin with similar appearance to Probiotic pills will be provided to participants allocated to the Placebo Arm.<br>|

What is the study measuring?
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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 |