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

Aging Clinical Trial

— PIE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04900701
• Other study ID #: 201209-B-01
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: January 2025

Study information

• Verified date: August 2022
• Source: University of Exeter
• Contact: Alistair Monteyne, PhD
• Phone: +44 (0)1392 72 4774
• Email: a.monteyne2[@]exeter.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: January 2025
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Malnutrition
• Muscle Atrophy
• Muscular Atrophy
• Protein-Energy Malnutrition

Intervention

Other:
• Energy status
Varying conditions of energy intake, thereby manipulating whether participants are in a state of energy restriction, balance, or surplus.

Locations

Country	Name	City	State
United Kingdom	Sport & Health Sciences University of Exeter	Exeter	Devon
United Kingdom	University of Exeter, Sports & Health Sciences, College of Life & Environmental Sciences	Exeter	Devon

Sponsors (1)

Lead Sponsor	Collaborator
University of Exeter

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Muscle morphology.	Changes in muscle size, measured via MRI scanning, during immobilisation.	3 day immobilisation phase.