- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06218264
BCAAs, Muscle Protein Synthesis and Glucose Uptake
January 11, 2024 updated by: Marlou Dirks, Wageningen University
The Role of Branched-chain Amino Acids (BCAAs) in the Stimulation of Skeletal Muscle Protein Synthesis and Glucose Uptake in Healthy Young Volunteers
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed 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).
Study Type
Interventional
Enrollment (Estimated)
28
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 Contact
- Name: Marlou Dirks, PhD
- Phone Number: +31 317 480 100
- Email: marlou.dirks@wur.nl
Study Locations
-
-
Gelderland
-
Wageningen, Gelderland, Netherlands, 6708 WD
- Recruiting
- Wageningen University and Research
-
Contact:
- Human and Animal Physiology
- Phone Number: +31 (0) 317 484 136
- Email: office.hap@wur.nl
-
-
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:
- 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 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: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: FullAA
Amino acid drink containing all amino acids
|
Oral intake of a supplement containing amino acids
|
Active Comparator: NoBCAA
Amino acid drink containing all amino acids except for BCAAs.
|
Oral intake of a supplement containing amino acids
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postprandial muscle protein synthesis
Time Frame: 4 hours
|
Muscle protein synthesis rate (FSR) prior to and following ingestion of an amino acid drink
|
4 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Forearm muscle glucose uptake
Time Frame: 7.5 hours
|
Insulin sensitivity, measured as forearm glucose uptake, prior to and following ingestion of an amino acid drink
|
7.5 hours
|
Whole-body insulin sensitivity
Time Frame: Four hours following ingestion of an amino acid drink
|
Whole-body insulin sensitivity, calculated using a modified Matsuda index
|
Four hours following ingestion of an amino acid drink
|
Forearm amino acid kinetics
Time Frame: Prior to and for 4 hours following amino acid intake
|
Plasma phenylalanine kinetics using a stable isotope tracer infusion
|
Prior to and for 4 hours following amino acid intake
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 10, 2024
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
January 11, 2024
First Submitted That Met QC Criteria
January 11, 2024
First Posted (Actual)
January 23, 2024
Study Record Updates
Last Update Posted (Actual)
January 23, 2024
Last Update Submitted That Met QC Criteria
January 11, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- NL82984.028.23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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