ProteinsQualipoisNCT04072770
Bioavailability of Protein and Amino Acids of Pea Protein Isolate in Healthy Volunteers
A study testing Pea and Casein in people with Proteins, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
Trial summary
The study aims to determine in healthy subjects the bioavailability of protein and amino acids of pea protein isolate and casein isolate. For this purpose, the investigators will compare two methods: 1. the standard method consisting in measuring the ileal digestibility using ileal tubes, 2. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Proteins
- What is being tested?
- Pea and Casein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2019to 30 May 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18<BMI<30
- Healthy
- Insured under the French social security system
- For women: use of birth control
- Signed informed consent
Who cannot join
- Any dietary allergy
- Latex allergy
- Positive serology to HIV, hepatite C virus antibody, hepatite B virus surface antigen and core antibodies
- Gluten intolerance
- Anemia
- Use of drugs
Show all 13Show fewer
- High consumption of alcohol
- Hypertension, diabetes, digestive disease, hepatic or renal disease, severe cardiac disease
- Pregnancy
- High sport practicing (>7h/wk)
- Blood donation in the 3 months prior to the study
- Participation in a clinical study in the 3 months prior to the study
- No signed informed consent
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Recherche sur Volontaires (CRV)
Bobigny, Île-de-France Region, 93000
About this study
The study aims to determine in healthy subjects the bioavailability of protein and amino acids of pea protein isolate and casein isolate. For this purpose, the investigators will compare two methods:
- the standard method consisting in measuring the ileal digestibility using ileal tubes,
- an alternative method that has been proposed by an Food and Agriculture Organization (FAO) expert group: the dual isotope method.
Read the detailed description
2 groups of healthy volunteers are recruited (males and females from 18 to 65 y old), BMI from 18 to 30.
Each group tests a protein source (30g) incorporated in a mashed potatoes that is divided in small portions to perform a repeated meal protocol. Protein sources (pea or casein) are intrinsically labeled with 15N and deuterium (2H).
The day before the meal test, the volunteers are equipped with an intestinal tube that migrates until the ileum. On the day of the experiment, the position of the intestinal tube is checked by radiography in order to verify its location at the terminal ileum. A catheter is inserted in the forearm vein for blood sampling. A saline solution containing polyethylene glycol 4000 (PEG-4000, 20 g/L), used as a non-absorbable marker of the intestinal flow, is infused into the ileum in order to calculate the flow rate of the intestinal effluents. After a basal blood and urine sampling, as well as a basal collection of ileal effluents performed for 30 min, subject ingests at t=0 the first biscuit dose. The small meal portions are ingested every 30 min for 4h, to achieve an isotopic plateau. Tracer doses of carbon 13 (13C) amino acids are ingested concomitantly with the meal doses. Non-absorbable marker (inulin) is added to the test meal to correct for incomplete recovery at the ileal level.
The postprandial sampling period lasts for 8 h after the meal ingestion. The intestinal content is continuously collected over ice and pooled every 30 min. Blood is sampled every 30 min for 4 h, and hourly thereafter.Total urine is collected every 2 h.
Measurements:
In the effluents, the investigators measure PEG 4000, nitrogen (N) and 15N, carbon and 13C, amino acids (AA), 15N and 13C in amino acids and the non-absorbable markers of the meal. The investigators calculate the ileal flow rate, the overall real ileal protein digestibility and the real ileal digestibility of individual amino acids.
In the plasma, the investigators measure uremia and 15N in urea, AA and protein to measure the transfer of dietary N in plasma protein pools; 15N, 2H and 13C in individual amino acids too measure the relative bioavailability of 15N/2H amino acids compared to free 13C amino acids.
In the urine, the investigators measure urea and 15N in the urea ammonia to calculate the postprandial deamination losses.
These measurements will allow to determine the protein and amino acid bioavailability from pea protein and compare it with casein, using the classical method implying ileal sampling and intrinsic tracer of dietary protein (15N). Additionally, it will allow to test a less invasive procedure using multiple tracers to assess the amino acid bioavailability.
- Conditions
- Proteins
- Being tested
- Pea, Casein
- Keywords
- Pea protein, Casein, Amino acid bioavailability, Protein digestibility, Isotopic tracers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeaDietary supplement
Proteins are intrinsically enriched with 15N and 2H. There are incorporated into mashed potatoes and the test meal is formulated to supply 30 g of pea protein per volunteer.
CaseinDietary supplement
Proteins are intrinsically enriched with 15N and 2H. There are incorporated into mashed potatoes and the test meal is formulated to supply 30 g of pea protein per volunteer.
| Study group | Role | What they receive |
|---|---|---|
| Pea | Experimental | Mashed potatoes meal containing pea protein isolate intrinsically labelled with 15N and 2H Receives: Dietary Supplement: Pea |
| Casein | Active comparator | Mashed potatoes meal containing casein isolate intrinsically labelled with 15N and 2H Receives: Dietary Supplement: Casein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of ileal digestibility of pea proteins and casein
Total N and 15N will be measured by Elemental Analyzer coupled to an Isotopic Ratio Mass Spectrometer (EA-IRMS) and the percentage of dietary N reaching the terminal ileum will be then determined. This percentage will be corrected by the ileal flow rate which is estimated with measurement of PEG concentration in effluents by a turbidimetric methods. Ileal digestibility of pea proteins and casein (i.e. N digestibility) will be calculated as 100 - corrected dietary N percentage.
Measured: -30 minute to 8 hours after the meal
Percentage of ileal digestibility of amino acids from pea proteins and casein
Amino acid concentrations will be measured by Ultra High Performance Liquid Chromatography (UHPLC) and 15N, 2H and 13C enrichment in individual amino acids will be measured by Gas Chromatography-Combustion-Isotope Ratio Mass Spectrometry (GC-C-IRMS) in order to determine the percentage of dietary individual amino acids reaching the terminal ileum. This percentage will be corrected by the ileal flow rate which is estimated with measurement of PEG concentration in effluents by a turbidimetric methods. Ileal digestibility of pea and casein amino acid will be calculated as 100 - corrected dietary amino acid percentage.
Measured: -30 minute to 8 hours after the meal
Percentage of net postprandial protein utilization of pea proteins and casein
Urea in plasma and urine (by enzymatic methods) will be determined and associated with 15N enrichment values (by EA IRMS) to determine the 15N transfer in plasma and urinary N pools and calculate the net postprandial protein utilization of pea protein and casein.
Measured: -30 minute to 8 hours after the meal
Postprandial concentration of dietary amino acids in plasma
Concentration of individual amino acids (alanine, arginine, asparagine, aspartic acid, cystein, glutamic acid, glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine, proline, phenylalanine, serine, threonine, valine, tryptophan, tyrosine) in plasma will be determined by UHPLC and associated with 15N enrichment values in individual amino acids (by GC C IRMS) to determined the concentration of dietary amino acids in plasma that comes from pea proteins and casein.
Measured: -30 minute to 8 hours after the meal
Postprandial concentration of glucose in plasma
Concentration of glucose (by enzymatic assay) will be determined in plasma.
Measured: -30 minute to 8 hours after the meal
Postprandial concentration of insulin in plasma
Concentration of insulin (by ELISA) will be determined in plasma.
Measured: -30 minute to 8 hours after the meal
Secondary outcomes (1)
Validation of the dual isotope method to assess the bioavailability of individual amino acids
Measurements of 15N, 2H and 13C amino acids in the plasma by GC-C-IRMS.
Measured: -30 minute to 8 hours after the meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start19 Jun 2019
- Primary completion30 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ProteinsStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Benamouzig, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072770
- Sponsor's protocol ID
- Qualipois
- Acronym
- Qualipois
- Status last verified
- May 2022
- First submitted
- 16 Jul 2019
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guillin FM, Gaudichon C, Guerin-Deremaux L, Lefranc-Millot C, Airinei G, Khodorova N, Benamouzig R, Pomport PH, Martin J, Calvez J. Values for the Digestibility of Pea Protein Isolate or Casein Amino Acids Determined using the Dual Isotope Method Are Not Similar to Those Derived with the Standard Ileal Balance Method in Healthy Volunteers. J Nutr. 2024 Feb;154(2):516-525. doi: 10.1016/j.tjnut.2023.12.039. Epub 2023 Dec 29.
PubMed 38160805Guillin FM, Gaudichon C, Guerin-Deremaux L, Lefranc-Millot C, Airinei G, Khodorova N, Benamouzig R, Pomport PH, Martin J, Calvez J. Real ileal amino acid digestibility of pea protein compared to casein in healthy humans: a randomized trial. Am J Clin Nutr. 2022 Feb 9;115(2):353-363. doi: 10.1093/ajcn/nqab354.
PubMed 34665230
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Protein and Amino Acids of Pea Protein Isolate in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04072770
- Acronym / sponsor ID
- Qualipois / Qualipois
- Conditions
- Proteins
- Keywords
- Pea protein, Casein, Amino acid bioavailability, Protein digestibility, Isotopic tracers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 28 Aug 2019 (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 study aims to determine in healthy subjects the bioavailability of protein and amino acids of pea protein isolate and casein isolate. For this purpose, the investigators will compare two methods:
- the standard method consisting in measuring the ileal digestibility using ileal tubes,
- an alternative method that has been proposed by an Food and Agriculture Organization (FAO) expert group: the dual isotope method.
Detailed description
2 groups of healthy volunteers are recruited (males and females from 18 to 65 y old), BMI from 18 to 30.
Each group tests a protein source (30g) incorporated in a mashed potatoes that is divided in small portions to perform a repeated meal protocol. Protein sources (pea or casein) are intrinsically labeled with 15N and deuterium (2H).
The day before the meal test, the volunteers are equipped with an intestinal tube that migrates until the ileum. On the day of the experiment, the position of the intestinal tube is checked by radiography in order to verify its location at the terminal ileum. A catheter is inserted in the forearm vein for blood sampling. A saline solution containing polyethylene glycol 4000 (PEG-4000, 20 g/L), used as a non-absorbable marker of the intestinal flow, is infused into the ileum in order to calculate the flow rate of the intestinal effluents. After a basal blood and urine sampling, as well as a basal collection of ileal effluents performed for 30 min, subject ingests at t=0 the first biscuit dose. The small meal portions are ingested every 30 min for 4h, to achieve an isotopic plateau. Tracer doses of carbon 13 (13C) amino acids are ingested concomitantly with the meal doses. Non-absorbable marker (inulin) is added to the test meal to correct for incomplete recovery at the ileal level.
The postprandial sampling period lasts for 8 h after the meal ingestion. The intestinal content is continuously collected over ice and pooled every 30 min. Blood is sampled every 30 min for 4 h, and hourly thereafter.Total urine is collected every 2 h.
Measurements:
In the effluents, the investigators measure PEG 4000, nitrogen (N) and 15N, carbon and 13C, amino acids (AA), 15N and 13C in amino acids and the non-absorbable markers of the meal. The investigators calculate the ileal flow rate, the overall real ileal protein digestibility and the real ileal digestibility of individual amino acids.
In the plasma, the investigators measure uremia and 15N in urea, AA and protein to measure the transfer of dietary N in plasma protein pools; 15N, 2H and 13C in individual amino acids too measure the relative bioavailability of 15N/2H amino acids compared to free 13C amino acids.
In the urine, the investigators measure urea and 15N in the urea ammonia to calculate the postprandial deamination losses.
These measurements will allow to determine the protein and amino acid bioavailability from pea protein and compare it with casein, using the classical method implying ileal sampling and intrinsic tracer of dietary protein (15N). Additionally, it will allow to test a less invasive procedure using multiple tracers to assess the amino acid bioavailability.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pea | Experimental | Dietary Supplement: PeaMashed potatoes meal containing pea protein isolate intrinsically labelled with 15N and 2H |
| Casein | Active comparator | Dietary Supplement: CaseinMashed potatoes meal containing casein isolate intrinsically labelled with 15N and 2H |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18<BMI<30
- Healthy
- Insured under the French social security system
- For women: use of birth control
- Signed informed consent
Key exclusion criteria (13 listed)
- Any dietary allergy
- Latex allergy
- Positive serology to HIV, hepatite C virus antibody, hepatite B virus surface antigen and core antibodies
- Gluten intolerance
- Anemia
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 |
|---|---|---|
| PeaProteins are intrinsically enriched with 15N and 2H. There are incorporated into mashed potatoes and the test meal is formulated to supply 30 g of pea protein per volunteer. | Dietary supplement | Pea |
| CaseinProteins are intrinsically enriched with 15N and 2H. There are incorporated into mashed potatoes and the test meal is formulated to supply 30 g of pea protein per volunteer. | Dietary supplement | Casein |
Primary outcome
Percentage of ileal digestibility of pea proteins and casein
Time frame: -30 minute to 8 hours after the meal
Total N and 15N will be measured by Elemental Analyzer coupled to an Isotopic Ratio Mass Spectrometer (EA-IRMS) and the percentage of dietary N reaching the terminal ileum will be then determined. This percentage will be corrected by the ileal flow rate which is estimated with measurement of PEG concentration in effluents by a turbidimetric methods. Ileal digestibility of pea proteins and casein (i.e. N digestibility) will be calculated as 100 - corrected dietary N percentage.
Percentage of ileal digestibility of amino acids from pea proteins and casein
Time frame: -30 minute to 8 hours after the meal
Amino acid concentrations will be measured by Ultra High Performance Liquid Chromatography (UHPLC) and 15N, 2H and 13C enrichment in individual amino acids will be measured by Gas Chromatography-Combustion-Isotope Ratio Mass Spectrometry (GC-C-IRMS) in order to determine the percentage of dietary individual amino acids reaching the terminal ileum. This percentage will be corrected by the ileal flow rate which is estimated with measurement of PEG concentration in effluents by a turbidimetric methods. Ileal digestibility of pea and casein amino acid will be calculated as 100 - corrected dietary amino acid percentage.
Percentage of net postprandial protein utilization of pea proteins and casein
Time frame: -30 minute to 8 hours after the meal
Urea in plasma and urine (by enzymatic methods) will be determined and associated with 15N enrichment values (by EA IRMS) to determine the 15N transfer in plasma and urinary N pools and calculate the net postprandial protein utilization of pea protein and casein.
Postprandial concentration of dietary amino acids in plasma
Time frame: -30 minute to 8 hours after the meal
Concentration of individual amino acids (alanine, arginine, asparagine, aspartic acid, cystein, glutamic acid, glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine, proline, phenylalanine, serine, threonine, valine, tryptophan, tyrosine) in plasma will be determined by UHPLC and associated with 15N enrichment values in individual amino acids (by GC C IRMS) to determined the concentration of dietary amino acids in plasma that comes from pea proteins and casein.
Postprandial concentration of glucose in plasma
Time frame: -30 minute to 8 hours after the meal
Concentration of glucose (by enzymatic assay) will be determined in plasma.
Postprandial concentration of insulin in plasma
Time frame: -30 minute to 8 hours after the meal
Concentration of insulin (by ELISA) will be determined in plasma.
1 secondary outcome
Validation of the dual isotope method to assess the bioavailability of individual amino acids
Time frame: -30 minute to 8 hours after the meal
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 1 Jun 2022.
- Derived from this study: PubMed 38160805Guillin FM, Gaudichon C, Guerin-Deremaux L, Lefranc-Millot C, Airinei G, Khodorova N, Benamouzig R, Pomport PH, Martin J, Calvez J. Values for the Digestibility of Pea Protein Isolate or Casein Amino Acids Determined using the Dual Isotope Method Are Not Similar to Those Derived with the Standard Ileal Balance Method in Healthy Volunteers. J Nutr. 2024 Feb;154(2):516-525. doi: 10.1016/j.tjnut.2023.12.039. Epub 2023 Dec 29.
- Derived from this study: PubMed 34665230Guillin FM, Gaudichon C, Guerin-Deremaux L, Lefranc-Millot C, Airinei G, Khodorova N, Benamouzig R, Pomport PH, Martin J, Calvez J. Real ileal amino acid digestibility of pea protein compared to casein in healthy humans: a randomized trial. Am J Clin Nutr. 2022 Feb 9;115(2):353-363. doi: 10.1093/ajcn/nqab354.
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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 and Casein in people with Proteins, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement 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 5 inclusion and 13 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 1 Jun 2022. 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?
Percentage of ileal digestibility of pea proteins and casein (time frame: -30 minute to 8 hours after the meal). The study lists 6 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 NCT04072770, which also lists 2 linked publications.
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 1 Jun 2022.