Clinical trial NCT05752266: Effect of Probiotics on Amino Acid Absorption
Official title: Effect of Probiotics on Amino Acid Absorption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Protein Digestion
Gastrointestinal Microbiome
Lead sponsor: Singapore Institute of Technology
Sponsor class: OTHER
Collaborators: name: AMILI Pte. Ltd.
First posted: 2023-03-02
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, placebo-controlled, crossover trial
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Change in blood amino acid concentration
timeFrame: 0 to 150 minutes after ingestion of plant protein beverage on each study visit
measure: Change in gut microbiota type
timeFrame: 0 to 6 weeks after start of study
measure: Change in gut microbiota population size
timeFrame: 0 to 6 weeks after start of study
Secondary outcomes:
measure: Change in blood glucose level
timeFrame: 0 to 150 minutes after ingestion of plant protein beverage
measure: Change in blood insulin level
timeFrame: 0 to 150 minutes after ingestion of plant protein beverage
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Verena Tan
state: Sinagpore
Study officials:
affiliation: +65 9172 4062
name: Verena Tan, M.Nutr.Diet
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.