The Impact of Energy Intake and Short-term Disuse on Muscle Protein Synthesis Rates and Skeletal Muscle Mass in Middle-aged Adults.

NCT04900701 | Active Not Recruiting

• 1 other identifier: 201209-B-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

In healthy middle-aged men and women, what is the effect of dietary energy restriction and energy surplus on daily muscle protein synthesis rates and muscle morphology, compared to energy balance, during free-living and immobilisation?

Conditions

Muscle Atrophy; Aging; Energy Malnutrition Protein

Keywords

Muscle protein synthesis; Ageing; Dietary protein; Disuse

Outcome Measures

Primary Outcomes (1)

• Muscle protein synthesis (MPS)

  Daily muscle protein synthesis rates, expressed as fractional synthetic rate (FSR) (%/day)

  6 days (3 days free-living, 3 days immobilised)

Secondary Outcomes (1)

• Muscle morphology.

  3 day immobilisation phase.

Study Arms (3)

Hypocaloric

EXPERIMENTAL

Participants placed in energy restriction.

Other: Energy status

Energy Balance

EXPERIMENTAL

Participants placed in energy balance.

Other: Energy status

Hypercaloric

EXPERIMENTAL

Participants placed in energy surplus.

Other: Energy status

Interventions

Energy status OTHER

Varying conditions of energy intake, thereby manipulating whether participants are in a state of energy restriction, balance, or surplus.

Energy Balance; Hypercaloric; Hypocaloric

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 35-65 Healthy Non-smoker Recreationally active

You may not qualify if:

• Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes) Any diagnosed cardiovascular disease or hypertension Elevated blood pressure at the time of screening. (An average systolic blood pressure reading of ≥150mmHg over two or more measurements and an average diastolic blood pressure of ≥90mmHg over two or more measurements.) Chronic use of diabetic medication. A personal or family history of epilepsy, seizures or schizophrenia. Allergic to mycoprotein / Quorn, penicillin, or cow's milk. Any musculoskeletal injury that may impair their use of crutches. Any diagnosed severe digestive illness. Any diagnosed severe autoimmune disease. Any diagnosed cancer. Any metal fragments in the eyes, a pacemaker, or metal implants in the body that preclude MRI scanning.

Sponsors & Collaborators

• University of Exeter: lead

Study Sites (2)

Sport & Health Sciences University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

Location

University of Exeter, Sports & Health Sciences, College of Life & Environmental Sciences

Exeter, Devon, EX1 2LU, United Kingdom

Location

MeSH Terms

Conditions

Muscular Atrophy; Protein-Energy Malnutrition

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Protein Deficiency; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 25, 2021
• Study Start: November 1, 2021
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)