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

Maastricht University Medical Centre (MUMC)

Status: Enrolling

Conditions: Healthy Males

Treatments: Dietary Supplement: Maltodextrin Supplement; Dietary Supplement: NEAA Supplement; Dietary Supplement: EAA Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT06687343

NL83031.068.22 / METC22-074

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 3 patient groups

EAA + NEAA

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: EAA Supplement

Dietary Supplement: NEAA Supplement

EAA + maltodextrin

Experimental group

Description:

Dietary intake of EAA, with NEAA replaced by maltodextrin

Treatment:

Dietary Supplement: EAA Supplement

Dietary Supplement: Maltodextrin Supplement

EAA

Experimental group

Description:

Dietary intake of EAA, with NEAA replaced by additional EAA

Treatment:

Dietary Supplement: EAA Supplement