- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06624033
Bioavailability of Legume Proteins in Differents Products (LEG'UP)
Single-blind, Randomized, Cross-over Comparative Bioavailability Study About the Kinetics of Plasma Amino Acid Concentrations Subsequent to the Consumption of Innovative Legume-based Products.
The use of pea proteins could be interesting in specific foods. Indeed, these proteins could have great nutritional quality, with good amino acid profile. Therefore, the investigators study the bioavailability of protein and post-prandial variation of metabolic markers following consumption of pea protein-enriched products in healthy young subjects.
Main Objective is to compare plasma kinetics of leucine.
Study Overview
Detailed Description
The written agreement of the subjects will be obtained after information on the aims, nature and possible risks of the study.
Before inclusion, the volunteers will be subjected to a medical check-up at the Nutritional Exploration Unit which includes an examination of personal and family history and current drug treatments, as well as a standard medical examination and a blood test for a biological check-up. Compliance with the inclusion/ exclusion criteria will be verified during this review.
Volunteers included in the protocol will go to the Clinical Pharmacology Center (CPC) to perform the tests. At each visit, each volunteer will receive one of the six products.
The volunteer will be reviewed six times for the realization of a kinetics. First, three visits will be made with at least 7 days apart (wash out period). Then, after a 15-day break, three others visits will be organized spaced at least 7 days apart. The day before each visit, the evening meal will be standardized and eaten before 9 pm. A short catheter will be placed in a vein in the forearm for blood samples. After a fasting blood sample (T0), the subjects will consume one of the test meals. Nine samples will be then collected at several times after meal ingestion.
On these samples, plasma concentrations of amino acids, insulin, blood sugar, lipid balance and inflammatory markers will be measured. Any intercurrent events will be noted in the observation book. The test meal sequence will be randomly assigned to subjects (generating a random list) prior to the start of the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Auvergne
-
Clermont-Ferrand, Auvergne, France, 63009
- Centre de Recherche en Nutrition Clinique d'Auvergne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Major male volunteers under 30 (<30)
- Body mass index between 22 and 28 kg/m²
- Subjects considered healthy by investigator based on the examination, medical and clinical examination,
- biological check up considered compatible with study participation
- person who is in the position to sign informed consent
Exclusion Criteria:
- Subject with a particular diet (vegetarians, vegans, nutritional supplements, etc.),
- Subject weight < 60 kg
- Subject refusing to consume one of the proposed products or the test meal
- Subject with a food allergy(s) to one or more components of the study products (gluten, legumes, etc.), or with a contribution to the consumption of these products.
- Subject with tumor pathology, inflammatory, moderate to severe kidney failure, malabsorption syndrome,
- Subject being under drug treatment or dietary supplement that may influence the results of kinetics: treatments that may affect gastric emptying, intestinal absorption (smectite-based intestinal dressings, etc.), insulin and blood sugar, Oral nutritional supplements (NOC), proton pump inhibitors (PPIs), corticosteroids, nonsteroidal anti-inflammatory drugs, antibiotics for less than a month,
- Subject with diabetes or dyslipidemia,
- Subject with a heavy medical or surgical history that may pose a risk to the volunteer under the protocol,
- Subject who has undergone surgery that may interfere with the objectives of the study (at the discretion of the investigating physician) within 3 months preceding the study,
- Person refusing to be registered on the National File of Healthy Volunteers of the Ministry of Health,
- Major subject under trusteeship or with limited rights,
- Subject not affiliated with social security,
- Subject during the exclusion period of a previous study (after verification in the Biomedical Research Volunteers File).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Chocolate cake with peas
the subjects will consume the test meals (arm title)
|
After a fasting blood sample (T0), the subjects will consume one of the test meals. Nine samples will be then collected at several times after meal ingestion. On these samples, plasma concentrations of amino acids, insulin, blood sugar, lipid balance and inflammatory markers will be measured. |
|
Experimental: Biscuit with peas
the subjects will consume the test meals (arm title).
|
After a fasting blood sample (T0), the subjects will consume one of the test meals. Nine samples will be then collected at several times after meal ingestion. On these samples, plasma concentrations of amino acids, insulin, blood sugar, lipid balance and inflammatory markers will be measured. |
|
Experimental: chopped steack with peas
the subjects will consume the test meals (arm title).
|
After a fasting blood sample (T0), the subjects will consume one of the test meals. Nine samples will be then collected at several times after meal ingestion. On these samples, plasma concentrations of amino acids, insulin, blood sugar, lipid balance and inflammatory markers will be measured. |
|
Placebo Comparator: Chocolate cake with gluten
the subjects will consume the test meals (arm title)
|
After a fasting blood sample (T0), the subjects will consume one of the test meals. Nine samples will be then collected at several times after meal ingestion. On these samples, plasma concentrations of amino acids, insulin, blood sugar, lipid balance and inflammatory markers will be measured. |
|
Placebo Comparator: biscuit with gluten
the subjects will consume the test meals (arm title).
|
After a fasting blood sample (T0), the subjects will consume one of the test meals. Nine samples will be then collected at several times after meal ingestion. On these samples, plasma concentrations of amino acids, insulin, blood sugar, lipid balance and inflammatory markers will be measured. |
|
Placebo Comparator: chopped steack
the subjects will consume the test meals (arm title).
|
After a fasting blood sample (T0), the subjects will consume one of the test meals. Nine samples will be then collected at several times after meal ingestion. On these samples, plasma concentrations of amino acids, insulin, blood sugar, lipid balance and inflammatory markers will be measured. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in the plasma concentrations of leucinemia
Time Frame: 0 minute before the consumption of the test meals
|
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point before (basal)
|
0 minute before the consumption of the test meals
|
|
Changes in the plasma concentrations of leucinemia
Time Frame: 15 minutes after ingestion
|
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 15 minutes after the consumption of one of the 6 test periods.
|
15 minutes after ingestion
|
|
Changes in the plasma concentrations of leucinemia
Time Frame: 30 minutes after ingestion
|
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 30 minutes after the consumption of one of the 6 test periods.
|
30 minutes after ingestion
|
|
Changes in the plasma concentrations of leucinemia
Time Frame: 60 minutes after ingestion
|
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 60 minutes after the consumption of one of the 6 test periods.
|
60 minutes after ingestion
|
|
Changes in the plasma concentrations of leucinemia
Time Frame: 90 minutes after ingestion meals
|
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 90 minutes after the consumption of one of the 6 test periods.
|
90 minutes after ingestion meals
|
|
Changes in the plasma concentrations of leucinemia
Time Frame: 120 minutes after ingestion
|
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 120 minutes after the consumption of one of the 6 test periods.
|
120 minutes after ingestion
|
|
Changes in the plasma concentrations of leucinemia
Time Frame: 150 minutes after ingestion
|
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 150 minutes after the consumption of one of the 6 test periods.
|
150 minutes after ingestion
|
|
Changes in the plasma concentrations of leucinemia
Time Frame: 180 minutes after ingestion
|
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 180 minutes after the consumption of one of the 6 test periods.
|
180 minutes after ingestion
|
|
Changes in the plasma concentrations of leucinemia
Time Frame: 210 minutes after ingestion
|
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 210 minutes after the consumption of one of the 6 test periods.
|
210 minutes after ingestion
|
|
Changes in the plasma concentrations of leucinemia
Time Frame: 240 minutes after ingestion
|
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 240 minutes after the consumption of one of the 6 test periods.
|
240 minutes after ingestion
|
|
Changes in the plasma concentrations of leucinemia
Time Frame: 270 minutes after ingestion
|
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 270 minutes after the consumption of one of the 6 test periods.
|
270 minutes after ingestion
|
|
Changes in the plasma concentrations of leucinemia
Time Frame: 300 minutes after ingestion
|
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product).One point at 300 minutes after the consumption of one of the 6 test periods.
|
300 minutes after ingestion
|
|
Changes in the plasma concentrations of leucinemia
Time Frame: 360 minutes after ingestion
|
Maximum total plasma concentration of leucinemia measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 360 minutes after the consumption of one of the 6 test periods.
|
360 minutes after ingestion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in the plasma concentrations of the others amino acids
Time Frame: 0 minute before the consumption of the test meals,
|
Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point before (basal) the consumption of one of the 6 test periods.
|
0 minute before the consumption of the test meals,
|
|
Changes in the plasma concentrations of the others amino acids
Time Frame: 15 minutes after ingestion
|
Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 15 minutes after the consumption of one of the 6 test periods.
|
15 minutes after ingestion
|
|
Changes in the plasma concentrations of the others amino acids
Time Frame: 30 minutes after ingestion
|
Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 30 minutes after the consumption of one of the 6 test periods.
|
30 minutes after ingestion
|
|
Changes in the plasma concentrations of the others amino acids
Time Frame: 45 minutes after ingestion
|
Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 45 minutes after the consumption of one of the 6 test periods.
|
45 minutes after ingestion
|
|
Changes in the plasma concentrations of the others amino acids
Time Frame: 60 minutes after ingestion
|
Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 60 minutes after the consumption of one of the 6 test periods.
|
60 minutes after ingestion
|
|
Changes in the plasma concentrations of the others amino acids
Time Frame: 90 minutes after ingestion
|
Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 90 minutes after the consumption of one of the 6 test periods.
|
90 minutes after ingestion
|
|
Changes in the plasma concentrations of the others amino acids
Time Frame: 120 minutes after ingestion
|
Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 120 minutes after the consumption of one of the 6 test periods.
|
120 minutes after ingestion
|
|
Changes in the plasma concentrations of the others amino acids
Time Frame: 180 minutes after ingestion
|
Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 180 minutes after the consumption of one of the 6 test periods.
|
180 minutes after ingestion
|
|
Changes in the plasma concentrations of the others amino acids
Time Frame: 210 minutes after ingestion
|
Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 210 minutes after the consumption of one of the 6 test periods.
|
210 minutes after ingestion
|
|
Changes in the plasma concentrations of the others amino acids
Time Frame: 240 minutes after ingestion
|
Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 240 minutes after the consumption of one of the 6 test periods.
|
240 minutes after ingestion
|
|
Changes in the plasma concentrations of the others amino acids
Time Frame: 270 minutes after ingestion
|
Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 270 minutes after the consumption of one of the 6 test periods.
|
270 minutes after ingestion
|
|
Changes in the plasma concentrations of the others amino acids
Time Frame: 300 minutes after ingestion
|
Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 300 minutes after the consumption of one of the 6 test periods.
|
300 minutes after ingestion
|
|
Changes in the plasma concentrations of the others amino acids
Time Frame: 360 minutes after ingestion
|
Maximum total plasma concentration of amino-acid measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 360 minutes after the consumption of one of the 6 test periods.
|
360 minutes after ingestion
|
|
Changes of Blood sugar levels
Time Frame: 0 minute before the consumption of the test meals
|
Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point before (basal) the consumption of one of the 6 test periods.
|
0 minute before the consumption of the test meals
|
|
Changes of Blood sugar levels
Time Frame: 15 minutes after ingestion
|
Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 15 minutes after the consumption of one of the 6 test periods.
|
15 minutes after ingestion
|
|
Changes of Blood sugar levels
Time Frame: 30 minutes after ingestion
|
Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 30 minutes after the consumption of one of the 6 test periods.
|
30 minutes after ingestion
|
|
Changes of Blood sugar levels
Time Frame: 45 minutes after ingestion
|
Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 45 minutes after the consumption of one of the 6 test periods.
|
45 minutes after ingestion
|
|
Changes of Blood sugar levels
Time Frame: 60 minutes after ingestion
|
Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 60 minutes after the consumption of one of the 6 test periods.
|
60 minutes after ingestion
|
|
Changes of Blood sugar levels
Time Frame: 90 minutes after ingestion
|
Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 90 minutes after the consumption of one of the 6 test periods.
|
90 minutes after ingestion
|
|
Changes of Blood sugar levels
Time Frame: 120 minutes after ingestion
|
Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 120 minutes after the consumption of one of the 6 test periods.
|
120 minutes after ingestion
|
|
Changes of Blood sugar levels
Time Frame: 150 minutes after ingestion
|
Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 150 minutes after the consumption of one of the 6 test periods.
|
150 minutes after ingestion
|
|
Changes of Blood sugar levels
Time Frame: 180 minutes after ingestion
|
Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 180 minutes after the consumption of one of the 6 test periods.
|
180 minutes after ingestion
|
|
Changes of Blood sugar levels
Time Frame: 210 minutes after ingestion
|
Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 210 minutes after the consumption of one of the 6 test periods.
|
210 minutes after ingestion
|
|
Changes of Blood sugar levels
Time Frame: 240 minutes after ingestion
|
Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 240 minutes after the consumption of one of the 6 test periods.
|
240 minutes after ingestion
|
|
Changes of Blood sugar levels
Time Frame: 270 minutes after ingestion
|
Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 270 minutes after the consumption of one of the 6 test periods.
|
270 minutes after ingestion
|
|
Changes of Blood sugar levels
Time Frame: 300 minutes after ingestion
|
Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 300 minutes after the consumption of one of the 6 test periods.
|
300 minutes after ingestion
|
|
Changes of Blood sugar levels
Time Frame: 360 minutes after ingestion
|
Maximum total concentration of blood sugar measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 360 minutes after the consumption of one of the 6 test periods.
|
360 minutes after ingestion
|
|
Changes of insulin levels
Time Frame: 0 minute before the consumption of the test meals
|
Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point before (basal) the consumption of one of the 6 test periods.
|
0 minute before the consumption of the test meals
|
|
Changes of insulin levels
Time Frame: 15 minutes after ingestion
|
Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 15 minutes after the consumption of one of the 6 test periods.
|
15 minutes after ingestion
|
|
Changes of insulin levels
Time Frame: 30 minutes after ingestion
|
Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 30 minutes after the consumption of one of the 6 test periods.
|
30 minutes after ingestion
|
|
Changes of insulin levels
Time Frame: 45 minutes after ingestion
|
Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 45 minutes after the consumption of one of the 6 test periods.
|
45 minutes after ingestion
|
|
Changes of insulin levels
Time Frame: 60 minutes after ingestion
|
Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 60 minutes after the consumption of one of the 6 test periods.
|
60 minutes after ingestion
|
|
Changes of insulin levels
Time Frame: 90 minutes after ingestion
|
Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 90 minutes after the consumption of one of the 6 test periods.
|
90 minutes after ingestion
|
|
Changes of insulin levels
Time Frame: 120 minutes after ingestion
|
Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 120 minutes after the consumption of one of the 6 test periods.
|
120 minutes after ingestion
|
|
Changes of insulin levels
Time Frame: 150 minutes after ingestion
|
Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 150 minutes after the consumption of one of the 6 test periods.
|
150 minutes after ingestion
|
|
Changes of insulin levels
Time Frame: 180 minutes after ingestion
|
Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 180 minutes after the consumption of one of the 6 test periods.
|
180 minutes after ingestion
|
|
Changes of insulin levels
Time Frame: 210 minutes after ingestion
|
Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 210 minutes after the consumption of one of the 6 test periods.
|
210 minutes after ingestion
|
|
Changes of insulin levels
Time Frame: 240 minutes after ingestion
|
Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 240 minutes after the consumption of one of the 6 test periods.
|
240 minutes after ingestion
|
|
Changes of insulin levels
Time Frame: 270 minutes after ingestion
|
Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 270 minutes after the consumption of one of the 6 test periods.
|
270 minutes after ingestion
|
|
Changes of insulin levels
Time Frame: 300 minutes after ingestion
|
Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 300 minutes after the consumption of one of the 6 test periods.
|
300 minutes after ingestion
|
|
Changes of insulin levels
Time Frame: 360 minutes after ingestion
|
Maximum total concentration of insulin measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 360 minutes after the consumption of one of the 6 test periods.
|
360 minutes after ingestion
|
|
Changes lipid profile
Time Frame: 0 minute before the consumption of the test meals
|
Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point before (basal) the consumption of one of the 6 test periods.
|
0 minute before the consumption of the test meals
|
|
Changes lipid profile
Time Frame: 15 minutes after ingestion
|
Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 15 minutes after the consumption of one of the 6 test periods.
|
15 minutes after ingestion
|
|
Changes lipid profile
Time Frame: 30 minutes after ingestion
|
Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 30 minutes after the consumption of one of the 6 test periods.
|
30 minutes after ingestion
|
|
Changes lipid profile
Time Frame: 45 minutes after ingestion
|
Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 45 minutes after the consumption of one of the 6 test periods.
|
45 minutes after ingestion
|
|
Changes lipid profile
Time Frame: 60 minutes after ingestion
|
Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 60 minutes after the consumption of one of the 6 test periods.
|
60 minutes after ingestion
|
|
Changes lipid profile
Time Frame: 90 minutes after ingestion
|
Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 90 minutes after the consumption of one of the 6 test periods.
|
90 minutes after ingestion
|
|
Changes lipid profile
Time Frame: 120 minutes after ingestion
|
Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 120 minutes after the consumption of one of the 6 test periods.
|
120 minutes after ingestion
|
|
Changes lipid profile
Time Frame: 150 minutes after ingestion
|
Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 150 minutes after the consumption of one of the 6 test periods.
|
150 minutes after ingestion
|
|
Changes lipid profile
Time Frame: 180 minutes after ingestion
|
Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 180 minutes after the consumption of one of the 6 test periods.
|
180 minutes after ingestion
|
|
Changes lipid profile
Time Frame: 210 minutes after ingestion
|
Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 210 minutes after the consumption of one of the 6 test periods.
|
210 minutes after ingestion
|
|
Changes lipid profile
Time Frame: 240 minutes after ingestion
|
Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 240 minutes after the consumption of one of the 6 test periods.
|
240 minutes after ingestion
|
|
Changes lipid profile
Time Frame: 270 minutes after ingestion
|
Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 270 minutes after the consumption of one of the 6 test periods.
|
270 minutes after ingestion
|
|
Changes lipid profile
Time Frame: 300 minutes after ingestion
|
Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 300 minutes after the consumption of one of the 6 test periods.
|
300 minutes after ingestion
|
|
Changes lipid profile
Time Frame: 360 minutes after ingestion
|
Maximum total concentration of lipid profile measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 360 minutes after the consumption of one of the 6 test periods.
|
360 minutes after ingestion
|
|
Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)
Time Frame: 0 minute before the consumption of the test meals
|
Maximum total plasma concentration of of the pro-inflammatory cytokines measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point before (basal) the consumption of one of the 6 test periods.
|
0 minute before the consumption of the test meals
|
|
Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)
Time Frame: 15 minutes after ingestion
|
Maximum total plasma concentration of of the pro-inflammatory cytokines measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 15 minutes after the consumption of one of the 6 test periods.
|
15 minutes after ingestion
|
|
Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)
Time Frame: 30 minutes after ingestion
|
Maximum total plasma concentration of of the pro-inflammatory cytokines measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 30 minutes after the consumption of one of the 6 test periods.
|
30 minutes after ingestion
|
|
Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)
Time Frame: 60 minutes after ingestion
|
Maximum total plasma concentration of of the pro-inflammatory cytokines measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 60 minutes after the consumption of one of the 6 test periods.
|
60 minutes after ingestion
|
|
Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)
Time Frame: 90 minutes after ingestion
|
Maximum total plasma concentration of of the pro-inflammatory cytokines measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 90 minutes after the consumption of one of the 6 test periods.
|
90 minutes after ingestion
|
|
Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)
Time Frame: 120 minutes after ingestion
|
Maximum total plasma concentration of of the pro-inflammatory cytokines measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 120 minutes after the consumption of one of the 6 test periods.
|
120 minutes after ingestion
|
|
Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)
Time Frame: 150 minutes after ingestion
|
Maximum total plasma concentration of of the pro-inflammatory cytokines measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 150 minutes after the consumption of one of the 6 test periods.
|
150 minutes after ingestion
|
|
Changes of pro-inflammatory cytokines (TNF α, IL-6 and IL-1β)
Time Frame: 240 minutes after ingestion
|
Maximum total plasma concentration of of the pro-inflammatory cytokines measured during different points of the 6 hours of the kinetics (one kinetic / type of product).
One point at 240 minutes after the consumption of one of the 6 test periods.
|
240 minutes after ingestion
|
|
Areas under curves
Time Frame: 0 minute before the consumption of the test meals
|
maximum concentration and time to reach this concentration will be compared between test meals
|
0 minute before the consumption of the test meals
|
|
Areas under curves
Time Frame: 15 minutes after ingestion
|
maximum concentration and time to reach this concentration will be compared between test meals
|
15 minutes after ingestion
|
|
Areas under curves
Time Frame: 30 minutes after ingestion
|
maximum concentration and time to reach this concentration will be compared between test meals
|
30 minutes after ingestion
|
|
Areas under curves
Time Frame: 60 minutes after ingestion
|
maximum concentration and time to reach this concentration will be compared between test meals
|
60 minutes after ingestion
|
|
Areas under curves
Time Frame: 90 minutes after ingestion
|
maximum concentration and time to reach this concentration will be compared between test meals
|
90 minutes after ingestion
|
|
Areas under curves
Time Frame: 120 minutes after ingestion
|
maximum concentration and time to reach this concentration will be compared between test meals
|
120 minutes after ingestion
|
|
Areas under curves
Time Frame: 180 minutes after ingestion
|
maximum concentration and time to reach this concentration will be compared between test meals
|
180 minutes after ingestion
|
|
Areas under curves
Time Frame: 240 minutes after ingestion
|
maximum concentration and time to reach this concentration will be compared between test meals
|
240 minutes after ingestion
|
|
Areas under curves
Time Frame: 300 minutes after ingestion
|
maximum concentration and time to reach this concentration will be compared between test meals
|
300 minutes after ingestion
|
|
Areas under curves
Time Frame: 360 minutes after ingestion
|
maximum concentration and time to reach this concentration will be compared between test meals
|
360 minutes after ingestion
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Marine Gueugneau, Phd, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CRNH 1 -2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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