Menu
Recruiting NCT06687343

The Importance of Non-essential Amino Acids for Maintaining Skeletal Muscle Protein Synthesis Rates in Healthy Young Men

No phase Interventional Healthy Males

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EAA Supplement, NEAA Supplement, Maltodextrin Supplement.
Who it may be relevant to
Registry conditions: Healthy Males. Basic parameters: 18 years — 35 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Dietary supplement EAA Supplement
    Dissolved in water and ingested 4 times a day
  • Dietary supplement NEAA Supplement
    Dissolved in water and ingested 4 times a day
  • Dietary supplement Maltodextrin Supplement
    Dissolved in water and ingested 4 times a day

Primary outcome measures

  • Integrated skeletal muscle protein fractional synthesis rates [Time frame: 10 days]
Secondary outcome measures (12)
  • Integrated skin protein fractional synthesis rates [Time frame: 10 days]
  • Muscle mass [Time frame: Baseline, 10 days]
  • Body fat composition [Time frame: Baseline, 10 days]
  • Resting energy expenditure [Time frame: Baseline, 10 days]
  • Systolic and diastolic blood pressure [Time frame: Baseline, 5 days, 10 days]
  • Resting heart rate [Time frame: Baseline, 5 days, 10 days]
  • Plasma amino acids [Time frame: Baseline, 5 days, 10 days]
  • Blood metabolites [Time frame: Baseline, 5 days, 10 days]
  • Urine metabolites [Time frame: Baseline, 5 days, 10 days]
  • Skeletal muscle mitochondrial respiration [Time frame: Baseline, 10 days]
  • Skeletal muscle signalling pathways [Time frame: Baseline, 10 days]
  • Body mass [Time frame: Baseline, 5 days, 10 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Basic science

Study locations

Netherlands · 1 center
  • Maastricht University Medical Center — Maastricht

Identifiers

NCT: NCT06687343 · NL83031.068.22 / METC22-074

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗