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

NCT06687343 | Recruiting DMC

• 1 other identifier: NL83031.068.22 / METC22-074
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Males

Keywords

muscle protein synthesis; amino acids

Outcome Measures

Primary Outcomes (1)

• Integrated skeletal muscle protein fractional synthesis rates

  Calculated by the change in deuterium labelled alanine in skeletal muscle protein

  10 days

Secondary Outcomes (17)

• Integrated skin protein fractional synthesis rates

  10 days

• Muscle mass

  Baseline, 10 days

• Body fat composition

  Baseline, 10 days

• Resting energy expenditure

  Baseline, 10 days

• Systolic and diastolic blood pressure

  Baseline, 5 days, 10 days

Other Outcomes (2)

• Age

  Baseline

• Height

  Baseline

Study Arms (3)

EAA + NEAA

ACTIVE COMPARATOR

Dietary intake of both EAA and NEAA, representing a normal diet

Dietary Supplement: EAA Supplement; Dietary Supplement: NEAA Supplement

EAA + maltodextrin

EXPERIMENTAL

Dietary intake of EAA, with NEAA replaced by maltodextrin

Dietary Supplement: EAA Supplement; Dietary Supplement: Maltodextrin Supplement

EAA

EXPERIMENTAL

Dietary intake of EAA, with NEAA replaced by additional EAA

Dietary Supplement: EAA Supplement

Interventions

EAA Supplement DIETARY_SUPPLEMENT

Dissolved in water and ingested 4 times a day

EAA; EAA + NEAA; EAA + maltodextrin

NEAA Supplement DIETARY_SUPPLEMENT

Dissolved in water and ingested 4 times a day

EAA + NEAA

Maltodextrin Supplement DIETARY_SUPPLEMENT

Dissolved in water and ingested 4 times a day

EAA + maltodextrin

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• Age between 18 and 35 y inclusive
• BMI between 22 and 30 kg/m2
• Non-smoker
• Having given informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Netherlands

RECRUITING

Central Study Contacts

Heather Petrick, MSc

CONTACT

0031883887244; h.petrick@maastrichtuniversity.nl

Luc van Loon, Prof, Dr.

CONTACT

0031433881397; l.vanloon@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 13, 2024
• Study Start: November 14, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 24, 2024

Record last verified: 2024-12

Locations

NL (1)