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

Primary Purpose

Muscle Atrophy, Aging, Energy Malnutrition Protein

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Energy status
Sponsored by
University of Exeter
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Muscle Atrophy focused on measuring Muscle protein synthesis, Ageing, Dietary protein, Disuse

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sport & Health Sciences University of ExeterRecruiting
  • University of Exeter, Sports & Health Sciences, College of Life & Environmental SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Hypocaloric

Energy Balance

Hypercaloric

Arm Description

Participants placed in energy restriction.

Participants placed in energy balance.

Participants placed in energy surplus.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 20, 2021
Last Updated
August 24, 2022
Sponsor
University of Exeter
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1. Study Identification

Unique Protocol Identification Number
NCT04900701
Brief Title
The Impact of Energy Intake and Short-term Disuse on Muscle Protein Synthesis Rates and Skeletal Muscle Mass in Middle-aged Adults.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Exeter

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Atrophy, Aging, Energy Malnutrition Protein
Keywords
Muscle protein synthesis, Ageing, Dietary protein, Disuse

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypocaloric
Arm Type
Experimental
Arm Description
Participants placed in energy restriction.
Arm Title
Energy Balance
Arm Type
Experimental
Arm Description
Participants placed in energy balance.
Arm Title
Hypercaloric
Arm Type
Experimental
Arm Description
Participants placed in energy surplus.
Intervention Type
Other
Intervention Name(s)
Energy status
Intervention Description
Varying conditions of energy intake, thereby manipulating whether participants are in a state of energy restriction, balance, or surplus.
Primary Outcome Measure Information:
Title
Muscle protein synthesis (MPS)
Description
Daily muscle protein synthesis rates, expressed as fractional synthetic rate (FSR) (%/day)
Time Frame
6 days (3 days free-living, 3 days immobilised)
Secondary Outcome Measure Information:
Title
Muscle morphology.
Description
Changes in muscle size, measured via MRI scanning, during immobilisation.
Time Frame
3 day immobilisation phase.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alistair Monteyne, PhD
Phone
+44 (0)1392 72 4774
Email
a.monteyne2@exeter.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Wall, PhD
Phone
+44 (0)1392 72 4774
Email
b.t.wall@exeter.ac.uk
Facility Information:
Facility Name
Sport & Health Sciences University of Exeter
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX1 2LU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin T Wall, PhD
Phone
+441392 724774
Ext
4774
Email
b.t.wall@exeter.ac.uk
Facility Name
University of Exeter, Sports & Health Sciences, College of Life & Environmental Sciences
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX1 2LU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin T Wall
Phone
+441392724774
Email
B.T.Wall@exeter.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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