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

NCT ID: NCT04900701

Last Updated: 2025-01-16

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2025-06-30

Brief Summary

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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?

Detailed Description

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Background Age related muscle tissue loss, which is associated with a number of negative health outcomes is partially caused by blunted muscle protein synthesis rates (MPS) in response to food ingestion, which is exacerbated by muscle disuse. Concomitantly, consuming an energy balanced diet appears to become more challenging with advancing age, due to a reduction in appetite. Of concern is that the impact of energy intake on muscle protein metabolism during ageing is poorly characterised.

Objective To determine daily MPS and muscle morphology in response to differing energy intakes, in free-living conditions and during immobilisation.

Methods Healthy middle-aged volunteers will consume a hypocaloric, energy-balanced, or hypercaloric diet (providing 1.4 g.kg.day protein) over a three-day free-living period, and a three day period of single leg immobilisation. Deuterium oxide and MRI scans will be used to measure daily MPS and muscle size, respectively.

Value The study will determine the effect of energy intake per se on daily muscle protein synthesis rates and muscle size, in free-living and immobilised conditions. This will inform how energy provision modulates tissue loss with ageing, and how this interacts with the catabolic stress of muscle disuse.

Conditions

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Muscle Atrophy Aging Energy Malnutrition Protein

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Hypocaloric

Participants placed in energy restriction.

Group Type EXPERIMENTAL

Energy status

Intervention Type OTHER

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

Energy Balance

Participants placed in energy balance.

Group Type EXPERIMENTAL

Energy status

Intervention Type OTHER

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

Hypercaloric

Participants placed in energy surplus.

Group Type EXPERIMENTAL

Energy status

Intervention Type OTHER

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

Interventions

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Energy status

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Age 35-65 Healthy Non-smoker Recreationally active

Exclusion Criteria

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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Exeter

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sport & Health Sciences University of Exeter

Exeter, Devon, United Kingdom

Site Status

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

Exeter, Devon, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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201209-B-01

Identifier Type: -

Identifier Source: org_study_id

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