Protein DigestionNCT05752266
Effect of Probiotics on Amino Acid Absorption
A study testing AMILI Probiotic pills in people with Protein Digestion and Gastrointestinal Microbiome, run by Singapore Institute of Technology at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Protein Digestion, Gastrointestinal Microbiome
- What is being tested?
- AMILI Probiotic pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- 27 Mar 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Protein Digestion, Gastrointestinal Microbiome
- Being tested
- AMILI Probiotic pills, Placebo pills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMILI Probiotic pillsDietary 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.
Placebo pillsDietary supplement
Placebo pills contaning maltodextrin with similar appearance to Probiotic pills will be provided to participants allocated to the Placebo Arm.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Arm | Experimental | Participants allocated to PRO arm will be administered personalized probiotic pills. Receives: 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. Receives: Dietary Supplement: Placebo pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 0 to 6 weeks after start of study
Secondary outcomes (2)
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.
Measured: 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.
Measured: 0 to 150 minutes after ingestion of plant protein beverage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start27 Mar 2023
- Primary completion14 Jul 2023
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Protein DigestionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, placebo-controlled, crossover trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- AMILI Pte. Ltd.
- Responsible party
- Principal investigator, Verena Tan Ming Hui, Singapore Institute of Technology
- Investigators
- Verena Tan, M.Nutr.Diet, Principal investigator, +65 9172 4062
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752266
- Sponsor's protocol ID
- 2022180
- Status last verified
- Nov 2024
- First submitted
- 17 Feb 2023
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 32358640
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotics on Amino Acid Absorption
- ClinicalTrials.gov ID
- NCT05752266
- Acronym / sponsor ID
- 2022180
- Conditions
- Protein Digestion, Gastrointestinal Microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Singapore Institute of TechnologyUniversity, hospital or other
- Collaborators
- AMILI Pte. Ltd.
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized, placebo-controlled, crossover trial
| Arm | Type | Receives |
|---|---|---|
| Probiotic Arm | Experimental | Dietary Supplement: AMILI Probiotic pillsParticipants allocated to PRO arm will be administered personalized probiotic pills. |
| Placebo Arm | Placebo comparator | Dietary Supplement: Placebo pillsParticipants allocated to PRO arm will be administered maltodextrin placebo pills similar in appearance to probiotic pills. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMILI Probiotic pillsAMILI (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. | Dietary supplement | Probiotic Arm |
| Placebo pillsPlacebo pills contaning maltodextrin with similar appearance to Probiotic pills will be provided to participants allocated to the Placebo Arm. | Dietary supplement | Placebo Arm |
Primary outcome
Change in blood amino acid concentration
Time frame: 0 to 150 minutes after ingestion of plant protein beverage on each study visit
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.
Change in gut microbiota type
Time frame: 0 to 6 weeks after start of study
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.
Change in gut microbiota population size
Time frame: 0 to 6 weeks after start of study
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.
2 secondary outcomes
Change in blood glucose level
Time frame: 0 to 150 minutes after ingestion of plant protein beverage
Change in blood insulin level
Time frame: 0 to 150 minutes after ingestion of plant protein beverage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Background: PubMed 32358640Jager 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Verena Tan, M.Nutr.Diet principal investigator
+65 9172 4062
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMILI Probiotic pills in people with Protein Digestion and Gastrointestinal Microbiome, run by Singapore Institute of Technology at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood amino acid concentration (time frame: 0 to 150 minutes after ingestion of plant protein beverage on each study visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05752266, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.