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| Name | Class |
|---|---|
| AMILI Pte. Ltd. | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic Arm | Experimental | Participants allocated to PRO arm will be administered personalized probiotic pills. |
|
| Placebo Arm | Placebo Comparator | Participants allocated to PRO arm will be administered maltodextrin placebo pills similar in appearance to probiotic pills. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Verena Tan, M.Nutr.Diet | +65 9172 4062 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Verena Tan | Singapore | Sinagpore | 138683 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32358640 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 16, 2023 | Feb 28, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 26, 2022 | Dec 16, 2022 | ICF_001.pdf |
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Randomized, placebo-controlled, crossover trial
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Masked personnel will be unaware of which arm each participant is allocated to, and what type of probiotics have been assigned to each participant.
| Placebo pills | Dietary Supplement | Placebo pills contaning maltodextrin with similar appearance to Probiotic pills will be provided to participants allocated to the Placebo Arm. |
|
| 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 |