Clinical trial NCT06687343: The Importance of Non-essential Amino Acids for Maintaining Skeletal Muscle Protein Synthesis Rates in Healthy Young Men
Official title: The Importance of Non-essential Amino Acids for Maintaining Skeletal Muscle Protein Synthesis Rates in Healthy Young Men
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Males
Keywords: muscle protein synthesis
amino acids
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 64
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


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

Primary outcomes:
measure: Integrated skeletal muscle protein fractional synthesis rates
timeFrame: 10 days
Secondary outcomes:
measure: Integrated skin protein fractional synthesis rates
timeFrame: 10 days
measure: Muscle mass
timeFrame: Baseline, 10 days
measure: Body fat composition
timeFrame: Baseline, 10 days
measure: Resting energy expenditure
timeFrame: Baseline, 10 days
measure: Systolic and diastolic blood pressure
timeFrame: Baseline, 5 days, 10 days
measure: Resting heart rate
timeFrame: Baseline, 5 days, 10 days
measure: Plasma amino acids
timeFrame: Baseline, 5 days, 10 days
measure: Blood metabolites
timeFrame: Baseline, 5 days, 10 days
measure: Urine metabolites
timeFrame: Baseline, 5 days, 10 days
measure: Skeletal muscle mitochondrial respiration
timeFrame: Baseline, 10 days
measure: Skeletal muscle signalling pathways
timeFrame: Baseline, 10 days
measure: Body mass
timeFrame: Baseline, 5 days, 10 days
measure: Dietary protein intake
timeFrame: 10 days
measure: Dietary fat intake
timeFrame: 10 days
measure: Dietary carbohydrate intake
timeFrame: 10 days
measure: Liver fat
timeFrame: Baseline, 10 days
measure: Body lean mass composition
timeFrame: Baseline, 10 days
Other outcomes:
measure: Age
timeFrame: Baseline
measure: Height
timeFrame: Baseline
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
References: