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

NCT ID: NCT06687343

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-14

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Males

Keywords

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muscle protein synthesis amino acids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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EAA + NEAA

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

Group Type ACTIVE_COMPARATOR

EAA Supplement

Intervention Type DIETARY_SUPPLEMENT

Dissolved in water and ingested 4 times a day

NEAA Supplement

Intervention Type DIETARY_SUPPLEMENT

Dissolved in water and ingested 4 times a day

EAA + maltodextrin

Dietary intake of EAA, with NEAA replaced by maltodextrin

Group Type EXPERIMENTAL

EAA Supplement

Intervention Type DIETARY_SUPPLEMENT

Dissolved in water and ingested 4 times a day

Maltodextrin Supplement

Intervention Type DIETARY_SUPPLEMENT

Dissolved in water and ingested 4 times a day

EAA

Dietary intake of EAA, with NEAA replaced by additional EAA

Group Type EXPERIMENTAL

EAA Supplement

Intervention Type DIETARY_SUPPLEMENT

Dissolved in water and ingested 4 times a day

Interventions

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EAA Supplement

Dissolved in water and ingested 4 times a day

Intervention Type DIETARY_SUPPLEMENT

NEAA Supplement

Dissolved in water and ingested 4 times a day

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin Supplement

Dissolved in water and ingested 4 times a day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maastricht University Medical Center

Maastricht, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Heather Petrick, MSc

Role: CONTACT

Phone: 0031883887244

Email: [email protected]

Luc van Loon, Prof, Dr.

Role: CONTACT

Phone: 0031433881397

Email: [email protected]

Facility Contacts

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Heather Petrick, MSc

Role: primary

Luc van Loon, Prof, Dr.

Role: backup

Heather Petrick, MSc

Role: backup

Other Identifiers

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NL83031.068.22 / METC22-074

Identifier Type: -

Identifier Source: org_study_id