Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06624033
Status:
COMPLETED
Last Update Posted:
None
First Post:
2020-11-09
Brief Title:
Bioavailability of Legume Proteins in Differents Products
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LEGUP
Brief Summary:
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
Main Objective is to compare plasma kinetics of leucine
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None