The Importance of Non-essential Amino Acids for Maintaining Skeletal Muscle Protein Synthesis Rat… (NCT06687343) | Clinical Trial Compass
RecruitingNot Applicable
The Importance of Non-essential Amino Acids for Maintaining Skeletal Muscle Protein Synthesis Rates in Healthy Young Men
Netherlands64 participantsStarted 2024-11-14
Plain-language summary
Background: Protein intake is important for maintaining skeletal muscle mass. These proteins consist of a collection of small building blocks which are called amino acids. There are two types of amino acids that are needed to build muscle: essential amino acids (EAA) and non-essential amino acids (NEAA). EAAs cannot be made in the body and must be consumed through foods, while NEAAs can be made within the body. However, if NEAA are not consumed through foods, the process of making NEAA in the body costs the body energy. It is still unknown what the impact of a diet containing too few non-essential amino acids is for muscle building and the body's energy metabolism.
Objective: To determine if a diet lacking NEAA, with or without being replaced by additional EAA, influences muscle protein building and whole-body metabolism.
Study design: Randomized, parallel design, double-blind, 10-day dietary intervention study.
Study population: 45 healthy (BMI 22-30 kg/m2) young males (age: 18-35 y inclusive).
Hypothesis: It is hypothesized that a diet lacking NEAA, with or without being replaced by additional EAA, decreases muscle protein building in humans.
Who can participate
Age range
18 Years – 35 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male
* Age between 18 and 35 y inclusive
* BMI between 22 and 30 kg/m2
* Non-smoker
* Having given informed consent
Exclusion Criteria:
* Participating in a structured (progressive) exercise program
* Smoker
* Diagnosed GI tract disorders or diseases
* Diagnosed musculoskeletal disorders
* Diagnosed metabolic disorders (e.g. diabetes)
* Cardiovascular disease
* Hypertension (blood pressure above 140/90 mmHg)
* Donated blood 3 months prior to test day
* Use of any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories).
* Chronic use of gastric acid suppressing medication
* Chronic use of anti-coagulants
* Any intolerance to foods included in the standardized diet intervention
* Any implants that would be a contra-indication for performing an MRI scan
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Integrated skeletal muscle protein fractional synthesis rates