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Completed

NCT Number: NCT04900701

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

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?

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Key information

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sport & Health Sciences University of Exeter, Exeter, Devon, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Energy status

Other

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

Primary outcomes

  1. Muscle protein synthesis (MPS)

    Time frame: 6 days (3 days free-living, 3 days immobilised)

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

Secondary outcomes

  1. Muscle morphology.

    Time frame: 3 day immobilisation phase.

    Changes in muscle size, measured via MRI scanning, during immobilisation.

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Registry information

Acronym: PIE

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 25, 2021
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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