Amino Acid Clinical Trial
Official title:
True Ileal Amino Acid Digestibility of Whey and Zein Proteins in Healthy Volunteers With Naso-ileal Tubes
Verified date | May 2022 |
Source | Institut National de la Recherche Agronomique |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main goal of the study is to determine true ileal amino acid digestibility of whey protein isolate (WPI) and zein proteins in healthy subjects equipped with naso-ileal tube. The endogenous losses of proteins and amino acids will be determined by collecting digesta samples after a protein-free diet in a third group of subjects.
Status | Completed |
Enrollment | 40 |
Est. completion date | December 20, 2019 |
Est. primary completion date | December 20, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Normal body weight (18 < BMI < 30 kg.m-2) - Women or men - 18 - 65 y - Healthy - Insured under the French social security system - Signed informed consent - For women: use of birth control Exclusion Criteria: - People under trusteeship - Latex, cow milk or corn allergy A - HIV, hepatite C virus antibodies, hepatite B virus surface antigen and core antibodies positive - Pregnant women - Excessive alcohol drinking or drugs intake - Hypertension, diabetes, digestive tract, liver or renal diseases, severe heart disease - High sport practicing (> 7h/week) - Blood donation in the 3 months prior to the study - Participation in a clinical study in the 3 months prior to the study - No signed informed consent |
Country | Name | City | State |
---|---|---|---|
France | CRNH Ile de France | Bobigny |
Lead Sponsor | Collaborator |
---|---|
Institut National de la Recherche Agronomique |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determination of the concentration of amino acids from dietary sources (whey or zein) in the ileal digesta collected during 9 hours after meal intake to calculate the digestibility of amino acids from whey or zein protein sources. | The quantity of amino acids will be determined by HPLC in the ileal digesta collected thanks to the naso-ileal tube during 9 hours after the meal intake. The obligatory endogenous amino acid losses will be estimated by determination of the amino acid content of ileal digesta after intake of the protein-free meal and this value will be subtracted to the values obtained after intake of protein meal to evaluate the quantity of amino acid which comes from dietary sources. Recovery of the indigestible markers (13C-inulin and celite) will allow correction for incomplete collection of digesta. | Hour 0 to 9 after intake | |
Secondary | Determination of the metabolic hormones plasma profile after zein or whey protein intake | Blood will be collected hourly during the 9 hours following the intake of the meal containing zein or whey protein. The profile of concentration of metabolic hormones (amylin, C-peptide, ghrelin, gastric inhibitory polypeptide, glucagon-like peptide 1, glucagon, interleukin -6, insulin, leptin, pancreatic polypeptide, polypeptide tyrosine tyrosine , tumor necrosis factor -a) in plasma will be determined by multiplex hormones assays kit. | Hour 0 to 9 after intake | |
Secondary | Determination of the effect of zein and whey protein on glucose homeostasis | Subjects are administered oral deuterated water the day before the investigation. Gluconeogenesis is assessed by measuring deuterium enrichment in body water and on C5 glucose position. | From the evening before the administration to 9 h after the meal. | |
Secondary | Determination of the effect of zein and whey protein on amino acid plasma concentration | Blood will be collected hourly during the 9 hours following the intake of the meal containing zein or whey protein. The profile of concentration of amino acids in plasma will be determined by ultra high performance liquid chromatography. | From the evening before the administration to 9 h after the meal. |
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