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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06218264
Other study ID # NL82984.028.23
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 10, 2024
Est. completion date December 31, 2025

Study information

Verified date January 2024
Source Wageningen University
Contact Marlou Dirks, PhD
Phone +31 317 480 100
Email marlou.dirks@wur.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The present study aims to quantify the insulin sensitivity and the skeletal muscle protein synthetic response to consuming a test drink containing all amino acids or all amino acids except for BCAAs.


Description:

Twenty-eight healthy, young volunteers will receive a stable isotope tracer infusion (7.5h) combined with repeated blood and muscle sampling, to measure muscle protein synthesis rate in the postabsorptive state following ingestion of a drink containing all amino acids (n=14) or all amino acids except for BCAAs (n=14).


Recruitment information / eligibility

Status Recruiting
Enrollment 28
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Aged from 18-35 years - 18.5 < Body mass index < 30 kg·m2 - Recreationally active (performing non-competitive physical exercise at least one time per week for minimally 30 minutes) Exclusion Criteria: - Smoking - Diabetes (Type 1, Type 2, or genetic form of diabetes) - Any diagnosed cardiovascular (heart) disease or high blood pressure (=140 mmHg systolic and/or =90 mmHg diastolic) - Chronic use of any prescribed or over the counter pharmaceuticals (excluding oral contraceptives and contraceptive devices) - Known allergy to lidocaine - Regular use of dietary protein and/or amino acid supplements (>3 times per week) - Currently involved in a structured progressive resistance training programme (>3 times per week) - A personal or family history of thrombosis (clots), epilepsy, seizures, or schizophrenia. - Any previous motor disorders or disorders in muscle and/or lipid metabolism - Presence of an ulcer in the stomach or gut and/or strong history of indigestion - Known severe kidney problems - Pregnant or breastfeeding - Unable to give consent

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Ingestion of an amino acid supplement
Oral intake of a supplement containing amino acids

Locations

Country Name City State
Netherlands Wageningen University and Research Wageningen Gelderland

Sponsors (1)

Lead Sponsor Collaborator
Wageningen University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postprandial muscle protein synthesis Muscle protein synthesis rate (FSR) prior to and following ingestion of an amino acid drink 4 hours
Secondary Forearm muscle glucose uptake Insulin sensitivity, measured as forearm glucose uptake, prior to and following ingestion of an amino acid drink 7.5 hours
Secondary Whole-body insulin sensitivity Whole-body insulin sensitivity, calculated using a modified Matsuda index Four hours following ingestion of an amino acid drink
Secondary Forearm amino acid kinetics Plasma phenylalanine kinetics using a stable isotope tracer infusion Prior to and for 4 hours following amino acid intake
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