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| Name | Class |
|---|---|
| Centre de Recherche en Nutrition Humaine d'Auvergne | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chocolate cake with peas | Experimental | the subjects will consume the test meals (arm title) |
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| Biscuit with peas | Experimental | the subjects will consume the test meals (arm title). |
|
| chopped steack with peas | Experimental | the subjects will consume the test meals (arm title). |
|
| Chocolate cake with gluten | Placebo Comparator | the subjects will consume the test meals (arm title) |
|
| biscuit with gluten | Placebo Comparator | the subjects will consume the test meals (arm title). |
|
| chopped steack | Placebo Comparator | the subjects will consume the test meals (arm title). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amino acids kinetics | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the plasma concentrations of leucinemia | 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 | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the plasma concentrations of the others amino acids | 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, |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marine Gueugneau, Phd | Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Recherche en Nutrition Clinique d'Auvergne | Clermont-Ferrand | Auvergne | 63009 | France |
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| ID | Term |
|---|---|
| D018761 | Multiple Endocrine Neoplasia Type 1 |
| ID | Term |
|---|---|
| D009377 | Multiple Endocrine Neoplasia |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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participants may receive 6 products in 6 interventions sequentially during the protocol
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single-centre randomized, cross-over controlled trial.
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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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Changes in the plasma concentrations of the others amino acids |
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | maximum concentration and time to reach this concentration will be compared between test meals | 15 minutes after ingestion |
| Areas under curves | maximum concentration and time to reach this concentration will be compared between test meals | 30 minutes after ingestion |
| Areas under curves | maximum concentration and time to reach this concentration will be compared between test meals | 60 minutes after ingestion |
| Areas under curves | maximum concentration and time to reach this concentration will be compared between test meals | 90 minutes after ingestion |
| Areas under curves | maximum concentration and time to reach this concentration will be compared between test meals | 120 minutes after ingestion |
| Areas under curves | maximum concentration and time to reach this concentration will be compared between test meals | 180 minutes after ingestion |
| Areas under curves | maximum concentration and time to reach this concentration will be compared between test meals | 240 minutes after ingestion |
| Areas under curves | maximum concentration and time to reach this concentration will be compared between test meals | 300 minutes after ingestion |
| Areas under curves | maximum concentration and time to reach this concentration will be compared between test meals | 360 minutes after ingestion |
| D009378 |
| Neoplasms, Multiple Primary |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |