Clinical trial NCT04900701: The Impact of Energy Intake and Short-term Disuse on Muscle Protein Synthesis Rates and Skeletal Muscle Mass in Middle-aged Adults.
Official title: The Impact of Energy Intake and Short-term Disuse on Muscle Protein Synthesis Rates and Skeletal Muscle Mass in Middle-aged Adults.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Muscle Atrophy
Aging
Energy Malnutrition Protein
Keywords: Muscle protein synthesis
Ageing
Dietary protein
Disuse
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 36
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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?

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Muscle protein synthesis (MPS)
timeFrame: 6 days (3 days free-living, 3 days immobilised)
Secondary outcomes:
measure: Muscle morphology.
timeFrame: 3 day immobilisation phase.
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Sport & Health Sciences University of Exeter
state: Devon
city: Exeter
country: United Kingdom
facility: University of Exeter, Sports & Health Sciences, College of Life & Environmental Sciences
state: Devon
Study officials:
References: