Healthy Male VolunteersNUTRALYSNCT06381869
Bioavailability of Pea Protein in Young and Old Volunteers
A study testing Pea protein (NUTRALYS ® S85 plus) in water, Pea protein (NUTRALYS ® S85 plus) within meal and Whey protein in water in people with Healthy Male Volunteers, run by Roquette Freres at 1 site in France.
Trial summary
The aim of this study done in healthy, non-malnourished young and elderly subjects, is to measure the bioavailability of protein intake and the variation of metabolic markers following consumption of pea protein " NUTRALYS ® S85 plus" or a reference protein brought in water either alone or at the end of a standardized… Read more about this study
- Who is it for?
- Ages 18 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- Pea protein (NUTRALYS ® S85 plus) in water, Pea protein (NUTRALYS ® S85 plus) within meal and Whey protein in water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jan 2019to 13 Jun 2019
- 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 85 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult male volunteers, aged over 65 or under 30
- Body mass index (weight in kg/ height² in m²) between 22 and 28 kg/m²,
- Subjects considered to be healthy by the principal investigator doctor according to the interview, medical and clinical examination,
- Biological assessment considered compatible with participation in the study,
- Persons able to sign the informed consent,
- Persons affiliated to social security scheme.
Who cannot join
- Pathologies or treatments not compatible with the study
- Food allergy or a contraindication to the consumption of the products tested
- Subject in a situation which, in the opinion of the investigator, could interfere with their optimal participation in the study or constitute a particular risk for the subject,
- Subject with a particular diet (vegetarians, vegans, nutritional supplements, etc.),
- Subject weighing < 55 kg,
Trial locations and contacts
1 site in 1 country.
France1 site
Unité d'Exploration en Nutrition Centre de Recherche en Nutrition Humaine d'Auvergne
Clermont-Ferrand, 63009
About this study
Official title: Study of Comparative Bioavailability, Randomized, in Open Cross Over the Kinetics of Subsequent Plasma Amino Acid Concentrations the Consumption of Pea Protein "NUTRALYS ® S85 Plus".
The aim of this study done in healthy, non-malnourished young and elderly subjects, is to measure the bioavailability of protein intake and the variation of metabolic markers following consumption of pea protein " NUTRALYS ® S85 plus" or a reference protein brought in water either alone or at the end of a standardized meal.
- Conditions
- Healthy Male Volunteers
- Being tested
- Pea protein (NUTRALYS ® S85 plus) in water, Pea protein (NUTRALYS ® S85 plus) within meal, Whey protein in water, Whey protein within meal
- Keywords
- Protein, Bioavailability, Pea protein, Amino acidemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pea protein (NUTRALYS ® S85 plus) in waterDietary supplement
After selection and randomization, the subjects will consume per os Pea protein (NUTRALYS® S85 plus) in water containing 0,41 g of tested protein/kg of body weight.
Pea protein (NUTRALYS ® S85 plus) within mealDietary supplement
After selection and randomization, the subjects will consume per os Pea protein (NUTRALYS® S85 plus) within a meal containing 0,41 g of tested protein/kg of body weight.
Whey protein in waterDietary supplement
After selection and randomization, the subjects will consume per os whey protein in water containing 0,41 g of tested protein/kg of body weight.
Whey protein within mealDietary supplement
After selection and randomization, the subjects will consume per os whey protein within a meal containing 0,41 g of tested protein/kg of body weight.
| Study group | Role | What they receive |
|---|---|---|
| Young volunteers | Other | Volunteers under 30 years old Receives: Dietary Supplement: Pea protein (NUTRALYS ® S85 plus) in water; Dietary Supplement: Pea protein (NUTRALYS ® S85 plus) within meal; Dietary Supplement: Whey protein in water; Dietary Supplement: Whey protein within meal |
| Elderly volunteers | Other | Volunteers over 65 years old. Receives: Dietary Supplement: Pea protein (NUTRALYS ® S85 plus) in water; Dietary Supplement: Pea protein (NUTRALYS ® S85 plus) within meal; Dietary Supplement: Whey protein in water; Dietary Supplement: Whey protein within meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leucine blood concentration
Measured: 0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
Secondary outcomes (6)
Essential amino acids blood concentration (µmol/L)
Measured: 0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
Non essential amino acid blood concentration (µmol/L)
Measured: 0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
Blood glucose concentration (g/L)
Measured: 0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
Blood insulin concentration (μIU/ml)
Measured: 0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
Blood lipid profile (glycerol concentration in mg/l and non-esterified fatty acids concentration in mg/l)
Measured: 0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
Blood inflammatory profile (TNF-α blood concentration in pg/ml and IL-6 blood concentration in pg/ml)
Measured: 0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start10 Jan 2019
- Primary completion13 Jun 2019
- Study completion13 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male VolunteersStudies 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
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roquette Freres
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne, Université d'Auvergne
- Responsible party
- Principal investigator, Ruddy Richard, Université d'Auvergne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381869
- Sponsor's protocol ID
- CRNHA 2018-2
- Acronym
- NUTRALYS
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 24 Apr 2024
- 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 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Comparative Bioavailability, Randomized, in Open Cross Over the Kinetics of Subsequent Plasma Amino Acid Concentrations the Consumption of Pea Protein "NUTRALYS ® S85 Plus".
- ClinicalTrials.gov ID
- NCT06381869
- Acronym / sponsor ID
- NUTRALYS / CRNHA 2018-2
- Conditions
- Healthy Male Volunteers
- Keywords
- Protein, Bioavailability, Pea protein, Amino acidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Roquette FreresIndustry (pharma, biotech, devices)
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne, Université d'Auvergne
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 13 Jun 2019 (actual)
- Study completion
- 13 Jun 2019 (actual)
- First posted
- 24 Apr 2024 (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 aim of this study done in healthy, non-malnourished young and elderly subjects, is to measure the bioavailability of protein intake and the variation of metabolic markers following consumption of pea protein " NUTRALYS ® S85 plus" or a reference protein brought in water either alone or at the end of a standardized meal.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young volunteers | Other | Dietary Supplement: Pea protein (NUTRALYS ® S85 plus) in water, Dietary Supplement: Pea protein (NUTRALYS ® S85 plus) within meal, Dietary Supplement: Whey protein in water, Dietary Supplement: Whey protein within mealVolunteers under 30 years old |
| Elderly volunteers | Other | Dietary Supplement: Pea protein (NUTRALYS ® S85 plus) in water, Dietary Supplement: Pea protein (NUTRALYS ® S85 plus) within meal, Dietary Supplement: Whey protein in water, Dietary Supplement: Whey protein within mealVolunteers over 65 years old. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult male volunteers, aged over 65 or under 30
- Body mass index (weight in kg/ height² in m²) between 22 and 28 kg/m²,
- Subjects considered to be healthy by the principal investigator doctor according to the interview, medical and clinical examination,
- Biological assessment considered compatible with participation in the study,
- Persons able to sign the informed consent,
Key exclusion criteria (5 listed)
- Pathologies or treatments not compatible with the study
- Food allergy or a contraindication to the consumption of the products tested
- Subject in a situation which, in the opinion of the investigator, could interfere with their optimal participation in the study or constitute a particular risk for the subject,
- Subject with a particular diet (vegetarians, vegans, nutritional supplements, etc.),
- Subject weighing < 55 kg,
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 (NUTRALYS ® S85 plus) in waterAfter selection and randomization, the subjects will consume per os Pea protein (NUTRALYS® S85 plus) in water containing 0,41 g of tested protein/kg of body weight. | Dietary supplement | Elderly volunteers, Young volunteers |
| Pea protein (NUTRALYS ® S85 plus) within mealAfter selection and randomization, the subjects will consume per os Pea protein (NUTRALYS® S85 plus) within a meal containing 0,41 g of tested protein/kg of body weight. | Dietary supplement | Elderly volunteers, Young volunteers |
| Whey protein in waterAfter selection and randomization, the subjects will consume per os whey protein in water containing 0,41 g of tested protein/kg of body weight. | Dietary supplement | Elderly volunteers, Young volunteers |
| Whey protein within mealAfter selection and randomization, the subjects will consume per os whey protein within a meal containing 0,41 g of tested protein/kg of body weight. | Dietary supplement | Elderly volunteers, Young volunteers |
Primary outcome
Leucine blood concentration
Time frame: 0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
6 secondary outcomes
Essential amino acids blood concentration (µmol/L)
Time frame: 0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
Non essential amino acid blood concentration (µmol/L)
Time frame: 0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
Blood glucose concentration (g/L)
Time frame: 0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
Blood insulin concentration (μIU/ml)
Time frame: 0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
Blood lipid profile (glycerol concentration in mg/l and non-esterified fatty acids concentration in mg/l)
Time frame: 0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
Blood inflammatory profile (TNF-α blood concentration in pg/ml and IL-6 blood concentration in pg/ml)
Time frame: 0 minute before eating the test meals, then regularly until 360 minutes after ingestion.
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 24 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 (NUTRALYS ® S85 plus) in water, Pea protein (NUTRALYS ® S85 plus) within meal and Whey protein in water in people with Healthy Male Volunteers, run by Roquette Freres at 1 site in France.
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 6 inclusion and 5 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 24 Apr 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 France. 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?
Leucine blood concentration (time frame: 0 minute before eating the test meals, then regularly until 360 minutes after ingestion.). 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 24 Apr 2024.