- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02152839
The Implementation of Novel 'Heavy' Water Techniques for Determining Modulation of Muscle Protein, DNA and Lipid Synthesis Due to Ageing
July 30, 2015 updated by: University of Nottingham
Maintenance of body's skeletal muscle is key to a healthy older age.
However, as we age we lose on average 1-2% of our muscle each year.
In order to slow this loss we need to understand fully the mechanisms regulating muscle mass with ageing.
In this project we aim to determine these mechanisms using a new novel technique of 'heavy' water ingestion, which will allow us to measure multiple aspects of skeletal muscle mass control during normal everyday activities in young and old individuals over a period of 6 weeks.
We will also determine the influence of resistance exercise training during this period in offsetting declines in muscle with ageing using this method
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Derby, United Kingdom, DE22 3DT
- Royal Derby Hospital Medical School
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Young (18-30y) and old men (65-75y) who are generally healthy and recreationally active
Exclusion Criteria:
- Active cardiovascular disease
- Cerebrovascular disease including previous stroke, aneurysm (large vessel or intracranial)
- Respiratory disease including pulmonary hypertension or COPD
- Hyper/ hypo parathyroidism, hyper/ hypothyroidism, Cushing's disease, diabetes
- Active inflammatory bowel disease
- Renal disease
- Malignancy
- Recent steroid treatment (within 6 mo), or hormone replacement therapy
- Clotting dysfunction
- Musculoskeletal or neurological disorders
- Any disease requiring long-term drug prescriptions, including statins
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Old Unilateral Exercise
Old individuals (65-75y) studied before and after 6 weeks of unilateral resistance exercise training
|
6 Weeks progressive unilateral resistance exercise, 3 times per week, 70% 1-RM, 6 x 8 Repetitions.
2 minutes rest between sets
|
Experimental: Young Unilateral Exercise
Young Individuals (18-30y) studied before and after 6 weeks unilateral resistance exercise training
|
6 Weeks progressive unilateral resistance exercise, 3 times per week, 70% 1-RM, 6 x 8 Repetitions.
2 minutes rest between sets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle Protein Synthesis
Time Frame: 0-6 Weeks
|
Comparison of muscle protein synthesis between young and older individuals and in response to 6 weeks unilateral exercise training
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0-6 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle Sub fractions
Time Frame: 0-6 week
|
Comparison of different sub fractions involved in muscle mass regulation between young and older individuals and in response unilateral exercise training
|
0-6 week
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle Functions
Time Frame: 0-6 Weeks
|
Muscle Strength and power un young and older individuals in response to unilateral exercise training
|
0-6 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Philip Atherton, PhD, AFHEA, University of Nottingham
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
July 1, 2014
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
May 29, 2014
First Submitted That Met QC Criteria
May 30, 2014
First Posted (Estimate)
June 2, 2014
Study Record Updates
Last Update Posted (Estimate)
July 31, 2015
Last Update Submitted That Met QC Criteria
July 30, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- Physoc_D20
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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