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

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Auvergne
      • Clermont-Ferrand, Auvergne, France, 63009
        • Centre de Recherche en Nutrition Clinique d'Auvergne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Marine Gueugneau, Phd, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2020

Primary Completion (Actual)

September 22, 2022

Study Completion (Actual)

September 22, 2023

Study Registration Dates

First Submitted

November 9, 2020

First Submitted That Met QC Criteria

September 30, 2024

First Posted (Actual)

October 2, 2024

Study Record Updates

Last Update Posted (Actual)

October 2, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • CRNH 1 -2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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