Resistance Exercise, Metabolism and Time of Day
Primary Purpose
Metabolic Disease
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise training
Sponsored by
About this trial
This is an interventional basic science trial for Metabolic Disease focused on measuring exercise, muscle, metabolism, circadian
Eligibility Criteria
Inclusion Criteria:
- pass the physical activity readiness questionnaire
- body mass index (BMI) >27kg/m² and limited to 40 kg/m².
Exclusion Criteria:
- Prior surgery for weight loss
- Prior history of heart, lung, cancer, endocrine or liver disease
- Participating in more than 1 hour structured exercise training per week
Sites / Locations
- Stuart Robert GrayRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control
Morning exercise
Evening exercise
Arm Description
Habitual physical activity
Exercise training in the morning (6:00-10:00am)
Exercise training in the evening (4:00-8:00pm)
Outcomes
Primary Outcome Measures
Change in insulin sensitivity
Insulin sensitivity calculated via the Matsuda Index during an oral glucose tolerance test
Secondary Outcome Measures
Change in vastus lateralis muscle thickness
Muscle thickness of the vastus lateralis muscle measured via ultrasound
Change in whole body lean mass
whole body lean mass measured via bio-electrical impedance
Change in whole body fat mass
whole body fat mass measured via bio-electrical impedance
Change in one-repetition maximum muscle strength
Sum of one-repetition maximum of Bench press, biceps curl, lat pull down, overhead press, lateral raise, leg extension, leg curl and calf raise exercise
Change in knee extensor maximal isometric torque
Knee extensor maximal isometric torque measured during a maximal voluntary contraction
Change in grip strength
Grip strength measured with a hand held dynamometer
Change in mean glucose levels
Mean glucose levels measured via continuous glucose monitors
Change in glucose variability
Glucose variability measured via continuous glucose monitors
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05321914
Brief Title
Resistance Exercise, Metabolism and Time of Day
Official Title
The Impact of the Time of Day on Metabolic Responses to Resistance Exercise in Adults Who Are Obese or Overweight: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Glasgow
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
The aim of the current study is to determine the effect of time of day on the muscle and metabolic responses to resistance exercises in obese or overweight adults. To achieve this aim we have the following objectives:
Compare the effects of resistance exercise training performed in the morning vs the evening on insulin sensitivity
Compare the effects of resistance exercise training performed in the morning vs the evening on gains in muscle mass and strength
Compare the acute glucose responses to resistance exercise performed in the morning vs the evening
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Disease
Keywords
exercise, muscle, metabolism, circadian
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Habitual physical activity
Arm Title
Morning exercise
Arm Type
Experimental
Arm Description
Exercise training in the morning (6:00-10:00am)
Arm Title
Evening exercise
Arm Type
Experimental
Arm Description
Exercise training in the evening (4:00-8:00pm)
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Intervention Description
Exercise will consist of 1 set x 9 exercises x 3 sessions per week x 6 weeks. The load to be used during training will be calculated as 80% of one-repetition maximum (1RM) with each set performed to failure. 1RM will be re-tested on week 3, and the load adjusted accordingly, and upon completion of the study. During the training period, all sessions of training will be supervised by the researcher. The following exercises will be performed: Bench press, biceps curl, lat pull down, overhead press, lateral raise, leg extension, leg curl and calf raise.
Primary Outcome Measure Information:
Title
Change in insulin sensitivity
Description
Insulin sensitivity calculated via the Matsuda Index during an oral glucose tolerance test
Time Frame
Change from baseline to 6 weeks
Secondary Outcome Measure Information:
Title
Change in vastus lateralis muscle thickness
Description
Muscle thickness of the vastus lateralis muscle measured via ultrasound
Time Frame
Change from baseline to 6 weeks
Title
Change in whole body lean mass
Description
whole body lean mass measured via bio-electrical impedance
Time Frame
Change from baseline to 6 weeks
Title
Change in whole body fat mass
Description
whole body fat mass measured via bio-electrical impedance
Time Frame
Change from baseline to 6 weeks
Title
Change in one-repetition maximum muscle strength
Description
Sum of one-repetition maximum of Bench press, biceps curl, lat pull down, overhead press, lateral raise, leg extension, leg curl and calf raise exercise
Time Frame
Change from baseline to 6 weeks
Title
Change in knee extensor maximal isometric torque
Description
Knee extensor maximal isometric torque measured during a maximal voluntary contraction
Time Frame
Change from baseline to 6 weeks
Title
Change in grip strength
Description
Grip strength measured with a hand held dynamometer
Time Frame
Change from baseline to 6 weeks
Title
Change in mean glucose levels
Description
Mean glucose levels measured via continuous glucose monitors
Time Frame
Change from baseline to 6 weeks
Title
Change in glucose variability
Description
Glucose variability measured via continuous glucose monitors
Time Frame
Change from baseline to 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
pass the physical activity readiness questionnaire
body mass index (BMI) >27kg/m² and limited to 40 kg/m².
Exclusion Criteria:
Prior surgery for weight loss
Prior history of heart, lung, cancer, endocrine or liver disease
Participating in more than 1 hour structured exercise training per week
Facility Information:
Facility Name
Stuart Robert Gray
City
Glasgow
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stuart R Gray
Phone
01413302569
Email
stuart.gray@glasgow.ac.uk
Phone
01413302569
Ext
Gray
Email
stuart.gray@glasgow.ac.uk
First Name & Middle Initial & Last Name & Degree
Stuart R Gray, PhD
12. IPD Sharing Statement
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Resistance Exercise, Metabolism and Time of Day
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