- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02624011
Influence of Sedentary Time on Skeletal Muscle Protein Metabolism
Influence of Increased Sedentary Time on Long-term Rates of Skeletal Muscle Protein Synthesis in Young Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sarcopenia, the loss of muscle mass with age, is thought to be accelerated by an inactive, sedentary lifestyle. Increased sedentary time has consistently been associated with lower muscle mass and compromised metabolic health. However, there is currently a lack of direct evidence to support these associations.
Therefore, this study will investigate whether increased sedentary time (reduced step count and exercise cessation) directly influences long-term measures of muscle protein synthesis and metabolic health in young, active adults. Following a 7 day period of normal habitual physical activity, participants will undertake a 7 day period of step reduction and exercise cessation. It is hypothesised that 7 days of increased sedentary time will result in a reduction in long-term rates of muscle protein synthesis and a worsening of metabolic health.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Birmingham, United Kingdom, B15 2TT
- School of Sport Exercise and Rehabilitation Sciences, University of Birmingham
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Body mass index (18.5-29.99 kg/m2)
- Active - defined as: ≥ 7000 steps per day (assessed during screening) and taking part in regular exercise (defined as participation in ≥ 3 sessions of aerobic and/or resistance exercise type sessions a week for ≥ 6 months prior to recruitment)
- Good general health
Exclusion Criteria:
- Lidocaine allergy
- Hypertension (≥140/90 mmHg)
- Current participation in another clinical study
- Previous participation in this study
- Bleeding disorder/s
- Current or recent smoker
- Past history of substance abuse and/or taking prescription or non-prescription medication (e.g., beta-blockers, insulin or thyroxine) or supplements that may influence normal metabolic responses.
- Participants who have previously (within 5 years of the present study) had 4 or more muscle biopsies obtained from the thigh quadriceps region will be ineligible.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Physical inactivity
Study arm consisting of 7 days of habitual physical activity followed by 7 days of step reduction and exercise cessation.
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Young, active participants will undergo a 7 day period of habitual physical activity followed by a 7 day period of step reduction and exercise cessation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle protein synthesis (FSR %/day)
Time Frame: 0-14 days
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Long-term muscle protein synthesis (FSR %/day) will be determined using deuterium oxide (D2O) to compare muscle protein synthesis rates over the first 7 day period and the second 7 day period.
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0-14 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of fat oxidation at rest (g/min)
Time Frame: For 20 minutes at day 7 and day 14
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Whole body oxygen consumption (VO2, L/min) and carbon dioxide production (VCO2, L/min) at rest will be measured using indirect calorimetry to calculate the rate of fat oxidation at rest (g/min).
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For 20 minutes at day 7 and day 14
|
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Rate of fat oxidation during an oral glucose tolerance test (g/min)
Time Frame: At 0, 30, 60, 90 and 120min of the oral glucose tolerance test at day 7 and day 14
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Whole body oxygen consumption (VO2, L/min) and carbon dioxide production (VCO2, L/min) following an oral glucose drink will be measured using indirect calorimetry to calculate the rate of fat oxidation during an oral glucose tolerance test (g/min).
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At 0, 30, 60, 90 and 120min of the oral glucose tolerance test at day 7 and day 14
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Rate of carbohydrate oxidation at rest (g/min)
Time Frame: For 20 minutes at day 7 and day 14
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Whole body oxygen consumption (VO2, L/min) and carbon dioxide production (VCO2, L/min) at rest will be measured using indirect calorimetry to calculate the rate of carbohydrate oxidation at rest (g/min).
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For 20 minutes at day 7 and day 14
|
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Rate of carbohydrate oxidation during an oral glucose tolerance test (g/min)
Time Frame: At 0, 30, 60, 90 and 120min of the oral glucose tolerance test at day 7 and day 14
|
Whole body oxygen consumption (VO2, L/min) and carbon dioxide production (VCO2, L/min) following an oral glucose drink will be measured using indirect calorimetry to calculate the rate of carbohydrate oxidation during an oral glucose tolerance test (g/min).
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At 0, 30, 60, 90 and 120min of the oral glucose tolerance test at day 7 and day 14
|
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Blood glucose concentration
Time Frame: At 0, 30, 60, 90 and 120min of the oral glucose tolerance test at day 7 and day 14
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Blood glucose concentration will be assessed in blood samples taken during the oral glucose tolerance test.
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At 0, 30, 60, 90 and 120min of the oral glucose tolerance test at day 7 and day 14
|
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Blood insulin concentration
Time Frame: At 0, 30, 60, 90 and 120min of the oral glucose tolerance test at day 7 and day 14
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Blood insulin concentration will be assessed in blood samples taken during the oral glucose tolerance test.
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At 0, 30, 60, 90 and 120min of the oral glucose tolerance test at day 7 and day 14
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Blood fatty acid concentration
Time Frame: At 0, 30, 60, 90 and 120min of the oral glucose tolerance test at day 7 and day 14
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Blood fatty acid concentration will be assessed in blood samples taken during the oral glucose tolerance test.
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At 0, 30, 60, 90 and 120min of the oral glucose tolerance test at day 7 and day 14
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Brandon J Shad, BSc, University of Birmingham
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ERN_15-1238
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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