Maastricht University Medical Center
Maastricht, Netherlands
Location status: Recruiting
Location contact
Heather Petrick, MSc
CONTACT
Heather Petrick, MSc
CONTACT
Luc van Loon, Prof, Dr.
CONTACT
Recruiting
NCT Number: NCT06687343
The Importance of Non-essential Amino Acids for Maintaining Skeletal Muscle Protein Synthesis Rates in Healthy Young Men
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–35 year
Sex eligibility
Male
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
EAA Supplement
Dietary SupplementDissolved in water and ingested 4 times a day
NEAA Supplement
Dietary SupplementDissolved in water and ingested 4 times a day
Maltodextrin supplement
Dietary SupplementDissolved in water and ingested 4 times a day
Primary outcomes
-
Integrated skeletal muscle protein fractional synthesis rates
Time frame: 10 days
Calculated by the change in deuterium labelled alanine in skeletal muscle protein
Secondary outcomes
-
Integrated skin protein fractional synthesis rates
Time frame: 10 days
Calculated by the change in deuterium labelled alanine in skin protein
-
Muscle mass
Time frame: Baseline, 10 days
Measured using Magnetic resonance imaging (MRI)
-
Body fat composition
Time frame: Baseline, 10 days
Measured using MRI
-
Resting energy expenditure
Time frame: Baseline, 10 days
Measured using indirect calorimetry
-
Systolic and diastolic blood pressure
Time frame: Baseline, 5 days, 10 days
Measured using automated device
-
Resting heart rate
Time frame: Baseline, 5 days, 10 days
Measured using automated device
-
Plasma amino acids
Time frame: Baseline, 5 days, 10 days
Measured in plasma samples
-
Blood metabolites
Time frame: Baseline, 5 days, 10 days
Assessed in plasma and serum samples
-
Urine metabolites
Time frame: Baseline, 5 days, 10 days
Measured in fasted urine samples
-
Skeletal muscle mitochondrial respiration
Time frame: Baseline, 10 days
Measured in skeletal muscle tissue collected from muscle biopsy
-
Skeletal muscle signalling pathways
Time frame: Baseline, 10 days
Measured in skeletal muscle tissue from muscle biopsy
-
Body mass
Time frame: Baseline, 5 days, 10 days
Assessed using scale
-
Dietary protein intake
Time frame: 10 days
Assessed by calculating the actual intakes from the provided diet
-
Dietary fat intake
Time frame: 10 days
Assessed by calculating the actual intakes from the provided diet
-
Dietary carbohydrate intake
Time frame: 10 days
Assessed by calculating the actual intakes from the provided diet
-
Liver fat
Time frame: Baseline, 10 days
Measured using MRI
-
Body lean mass composition
Time frame: Baseline, 10 days
Measured using MRI
Other outcomes
-
Age
Time frame: Baseline
At baseline, assessed using questionnaire
-
Height
Time frame: Baseline
Assessed using stadiometer
Study contacts
Contact information is provided by the study sponsor or research team.
Heather Petrick, MSc
CONTACT
Luc van Loon, Prof, Dr.
CONTACT
Sponsors and collaborators
Lead sponsor
Maastricht University Medical Center
Other
Registry information
Acronym: NEAA
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Nov 13, 2024
- Registry last updated
- Dec 24, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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