NCT04900701

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2024

Completed
Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

2.6 years

First QC Date

May 20, 2021

Last Update Submit

May 5, 2026

Conditions

Keywords

Muscle protein synthesisAgeingDietary proteinDisuse

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Muscle morphology.

    3 day immobilisation phase.

Study Arms (3)

Hypocaloric

EXPERIMENTAL

Participants placed in energy restriction.

Other: Energy status

Energy Balance

EXPERIMENTAL

Participants placed in energy balance.

Other: Energy status

Hypercaloric

EXPERIMENTAL

Participants placed in energy surplus.

Other: Energy status

Interventions

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

Energy BalanceHypercaloricHypocaloric

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 35-65 Healthy Non-smoker Recreationally active

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sport & Health Sciences University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

Location

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

Exeter, Devon, EX1 2LU, United Kingdom

Location

MeSH Terms

Conditions

Muscular AtrophyProtein-Energy Malnutrition

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsProtein DeficiencyDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2021

First Posted

May 25, 2021

Study Start

November 1, 2021

Primary Completion

June 3, 2024

Study Completion

June 3, 2024

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations