Bioavailability of Amino Acids Following Oral Ingestion of Plant-Based Proteins in Young, Healthy MenNCT04872530
Bioavailability of Plant Protein Amino Acids
A study testing Pea-protein concentrate, Fava-bean protein concentrate and Chickpea protein concentrate in people with Bioavailability of Amino Acids Following Oral Ingestion of Plant-Based Proteins in Young, Healthy Men, run by University of Limerick at 1 site in Ireland.
Trial summary
This study aims to inform of the mechanism of action of plant-based protein by measuring the bioavailability (i.e. rate of appearance and magnitude of concentration in the circulation following oral ingestion) of key amino acid and metabolic products that regulate skeletal muscle protein synthesis (MPS) in humans. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bioavailability of Amino Acids Following Oral Ingestion of Plant-Based Proteins in Young, Healthy Men
- What is being tested?
- Pea-protein concentrate, Fava-bean protein concentrate and Chickpea protein concentrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIreland
- Study dates
- 8 Jan 2020to 29 Sep 2023
- 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- No known intolerance to any item contained in the protein products.
- No blood borne disease risk, current illness or medication that would adversely affect participation
- No known adverse reaction to venepuncture
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioavailability of Amino Acids and Metabolic Products Following Oral Ingestion of Plant-Based Proteins in Young, Healthy Men and Women Aged 18-35y
This study aims to inform of the mechanism of action of plant-based protein by measuring the bioavailability (i.e. rate of appearance and magnitude of concentration in the circulation following oral ingestion) of key amino acid and metabolic products that regulate skeletal muscle protein synthesis (MPS) in humans.
Read the detailed description
Plant-based proteins contain several amino acids that are essential to signal muscle growth/repair and act as a substrate during muscle protein synthesis. However, compared to animal protein or free-amino acids, the bioavailability of certain essential amino acids may be compromised. Following selective processing (e.g. removal of carbohydrate and/or other anti-nutritive factors) food grade plant-based protein concentrates possibly confer greater bioavailability and bioactivity in vivo. This project explores the bioavailability and bioactivity of selected plant-based protein concentrates following oral ingestion in young, healthy men and women.
- Being tested
- Pea-protein concentrate, Fava-bean protein concentrate, Chickpea protein concentrate, Red lentil protein concentrate, Non-essential amino acid blend
- Keywords
- Bioavailability of Amino Acids Following Oral Ingestion of Plant-Based Proteins in Young, Healthy Men
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pea-protein concentrateDietary supplement
Pea-protein concentrate
Fava-bean protein concentrateDietary supplement
Fava-bean protein concentrate
Chickpea protein concentrateDietary supplement
Chickpea protein concentrate
Red lentil protein concentrateDietary supplement
Red lentil protein concentrate
Non-essential amino acid blendDietary supplement
Non-essential amino acid blend
Whey protein concentrateDietary supplement
Whey protein concentrate
| Study group | Role | What they receive |
|---|---|---|
| Pea-protein concentrate | Experimental | Pea-protein concentrate dosed at 0.33 g/kg body mass in 500 ml of water. Receives: Dietary Supplement: Pea-protein concentrate |
| Fava-bean protein concentrate | Experimental | Fava-bean protein concentrate dosed at 0.33 g/kg body mass in 500 ml of water. Receives: Dietary Supplement: Fava-bean protein concentrate |
| Chickpea protein concentrate | Experimental | Chickpea protein concentrate dosed at 0.33 g/kg body mass in 500 ml of water. Receives: Dietary Supplement: Chickpea protein concentrate |
| Red lentil protein concentrate | Experimental | Red lentil protein concentrate dosed at 0.33 g/kg body mass in 500 ml of water. Receives: Dietary Supplement: Red lentil protein concentrate |
| Non-essential amino acid blend | Experimental | Non-essential amino acid blend dosed at 0.33 g/kg body mass in 500 ml of water. Receives: Dietary Supplement: Non-essential amino acid blend |
| Whey protein concentrate | Experimental | Whey protein concentrate dosed at 0.33 g/kg body mass in 500 ml of water. Receives: Dietary Supplement: Whey protein concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma amino acids
Plasma amino acids measured by HPLC
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start8 Jan 2020
- Primary completion31 May 2021
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioavailability of Amino Acids Following Oral Ingestion of Plant-Based Proteins in Young, Healthy MenStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects who volunteer for this study will undertake SIX controlled feeding trials, each trial separated by 7 days.Subjects will be assigned to a randomised sequence of six protein isolates including: (1) pea-protein concentrate; (2) fava-bean protein concentrate; (3) chickpea protein concentrate; (4) red lentil protein concentrate; (5) non-essential amino acid blend (negative control);( 6) whey protein concentrate. Protein is dosed at 0.33 g/kg body mass in 500 ml of water.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Collaborators
- Marigot Ltd., Enterprise Ireland
- Responsible party
- Sponsor
- Investigators
- Phil Jakeman, PhD, Principal investigator, University of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872530
- Sponsor's protocol ID
- 2019_12_02_EHS
- Status last verified
- Nov 2023
- First submitted
- 29 Apr 2021
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Amino Acids and Metabolic Products Following Oral Ingestion of Plant-Based Proteins in Young, Healthy Men and Women Aged 18-35y
- ClinicalTrials.gov ID
- NCT04872530
- Acronym / sponsor ID
- 2019_12_02_EHS
- Keywords
- Bioavailability of Amino Acids Following Oral Ingestion of Plant-Based Proteins in Young, Healthy Men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Collaborators
- Marigot Ltd., Enterprise Ireland
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 4 May 2021 (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.
This study aims to inform of the mechanism of action of plant-based protein by measuring the bioavailability (i.e. rate of appearance and magnitude of concentration in the circulation following oral ingestion) of key amino acid and metabolic products that regulate skeletal muscle protein synthesis (MPS) in humans.
Detailed description
Plant-based proteins contain several amino acids that are essential to signal muscle growth/repair and act as a substrate during muscle protein synthesis. However, compared to animal protein or free-amino acids, the bioavailability of certain essential amino acids may be compromised. Following selective processing (e.g. removal of carbohydrate and/or other anti-nutritive factors) food grade plant-based protein concentrates possibly confer greater bioavailability and bioactivity in vivo. This project explores the bioavailability and bioactivity of selected plant-based protein concentrates following oral ingestion in young, healthy men and women.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- Subjects who volunteer for this study will undertake SIX controlled feeding trials, each trial separated by 7 days.Subjects will be assigned to a randomised sequence of six protein isolates including: (1) pea-protein concentrate; (2) fava-bean protein concentrate; (3) chickpea protein concentrate; (4) red lentil protein concentrate; (5) non-essential amino acid blend (negative control);( 6) whey protein concentrate. Protein is dosed at 0.33 g/kg body mass in 500 ml of water.
| Arm | Type | Receives |
|---|---|---|
| Pea-protein concentrate | Experimental | Dietary Supplement: Pea-protein concentratePea-protein concentrate dosed at 0.33 g/kg body mass in 500 ml of water. |
| Fava-bean protein concentrate | Experimental | Dietary Supplement: Fava-bean protein concentrateFava-bean protein concentrate dosed at 0.33 g/kg body mass in 500 ml of water. |
| Chickpea protein concentrate | Experimental | Dietary Supplement: Chickpea protein concentrateChickpea protein concentrate dosed at 0.33 g/kg body mass in 500 ml of water. |
| Red lentil protein concentrate | Experimental | Dietary Supplement: Red lentil protein concentrateRed lentil protein concentrate dosed at 0.33 g/kg body mass in 500 ml of water. |
| Non-essential amino acid blend | Experimental | Dietary Supplement: Non-essential amino acid blendNon-essential amino acid blend dosed at 0.33 g/kg body mass in 500 ml of water. |
| Whey protein concentrate | Experimental | Dietary Supplement: Whey protein concentrateWhey protein concentrate dosed at 0.33 g/kg body mass in 500 ml of water. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- No known intolerance to any item contained in the protein products.
- No blood borne disease risk, current illness or medication that would adversely affect participation
- No known adverse reaction to venepuncture
Key exclusion criteria (1 listed)
- n/a
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 |
|---|---|---|
| Pea-protein concentratePea-protein concentrate | Dietary supplement | Pea-protein concentrate |
| Fava-bean protein concentrateFava-bean protein concentrate | Dietary supplement | Fava-bean protein concentrate |
| Chickpea protein concentrateChickpea protein concentrate | Dietary supplement | Chickpea protein concentrate |
| Red lentil protein concentrateRed lentil protein concentrate | Dietary supplement | Red lentil protein concentrate |
| Non-essential amino acid blendNon-essential amino acid blend | Dietary supplement | Non-essential amino acid blend |
| Whey protein concentrateWhey protein concentrate | Dietary supplement | Whey protein concentrate |
Primary outcome
Plasma amino acids
Time frame: 3 hours
Plasma amino acids measured by HPLC
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 30 Nov 2023.
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.
Phil Jakeman, PhD principal investigator
University of Limerick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pea-protein concentrate, Fava-bean protein concentrate and Chickpea protein concentrate in people with Bioavailability of Amino Acids Following Oral Ingestion of Plant-Based Proteins in Young, Healthy Men, run by University of Limerick at 1 site in Ireland.
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 1 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 30 Nov 2023. 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 Ireland. 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. 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?
Plasma amino acids (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Nov 2023.