HealthyNCT02152839
The Implementation of Novel 'Heavy' Water Techniques for Determining Modulation of Muscle Protein, DNA and Lipid Synthesis Due to Ageing
A study testing Resistance Exercise in people with Healthy, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Resistance Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Young (18-30y) and old men (65-75y) who are generally healthy and recreationally active
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Derby Hospital Medical School
Derby, DE22 3DT
About this study
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
- Conditions
- Healthy
- Being tested
- Resistance Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance ExerciseBehavioural
6 Weeks progressive unilateral resistance exercise, 3 times per week, 70% 1-RM, 6 x 8 Repetitions. 2 minutes rest between sets
| Study group | Role | What they receive |
|---|---|---|
| Old Unilateral Exercise | Experimental | Old individuals (65-75y) studied before and after 6 weeks of unilateral resistance exercise training Receives: Behavioral: Resistance Exercise |
| Young Unilateral Exercise | Experimental | Young Individuals (18-30y) studied before and after 6 weeks unilateral resistance exercise training Receives: Behavioral: Resistance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Protein Synthesis
Comparison of muscle protein synthesis between young and older individuals and in response to 6 weeks unilateral exercise training
Measured: 0-6 Weeks
Secondary outcomes (1)
Muscle Sub fractions
Comparison of different sub fractions involved in muscle mass regulation between young and older individuals and in response unilateral exercise training
Measured: 0-6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startMay 2013
- Primary completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Physiological Society
- Responsible party
- Sponsor
- Investigators
- Philip Atherton, PhD, AFHEA, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152839
- Sponsor's protocol ID
- Physoc_D20
- Status last verified
- Jul 2015
- First submitted
- 29 May 2014
- Last updated
- 31 Jul 2015
- Results posted
- No
Publications
Brook MS, Wilkinson DJ, Tarum J, Mitchell KW, Lund JL, Phillips BE, Szewczyk NJ, Kadi F, Greenhaff PL, Smith K, Atherton PJ. Neither myonuclear accretion nor a myonuclear domain size ceiling is a feature of the attenuated hypertrophic potential of aged human skeletal muscle. Geroscience. 2023 Feb;45(1):451-462. doi: 10.1007/s11357-022-00651-y. Epub 2022 Sep 9.
PubMed 36083436
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Implementation of Novel 'Heavy' Water Techniques for Determining Modulation of Muscle Protein, DNA and Lipid Synthesis Due to Ageing
- ClinicalTrials.gov ID
- NCT02152839
- Acronym / sponsor ID
- Physoc_D20
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Physiological Society
- Study start
- May 2013
- Primary completion
- Jul 2014 (actual)
- First posted
- 2 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Old Unilateral Exercise | Experimental | Behavioral: Resistance ExerciseOld individuals (65-75y) studied before and after 6 weeks of unilateral resistance exercise training |
| Young Unilateral Exercise | Experimental | Behavioral: Resistance ExerciseYoung Individuals (18-30y) studied before and after 6 weeks unilateral resistance exercise training |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Young (18-30y) and old men (65-75y) who are generally healthy and recreationally active
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance Exercise6 Weeks progressive unilateral resistance exercise, 3 times per week, 70% 1-RM, 6 x 8 Repetitions. 2 minutes rest between sets | Behavioural | Old Unilateral Exercise, Young Unilateral Exercise |
Primary outcome
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
1 secondary outcome
Muscle Sub fractions
Time frame: 0-6 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
- Derived from this study: PubMed 36083436Brook MS, Wilkinson DJ, Tarum J, Mitchell KW, Lund JL, Phillips BE, Szewczyk NJ, Kadi F, Greenhaff PL, Smith K, Atherton PJ. Neither myonuclear accretion nor a myonuclear domain size ceiling is a feature of the attenuated hypertrophic potential of aged human skeletal muscle. Geroscience. 2023 Feb;45(1):451-462. doi: 10.1007/s11357-022-00651-y. Epub 2022 Sep 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Atherton, PhD, AFHEA principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise in people with Healthy, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Protein Synthesis (time frame: 0-6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02152839, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2015.