HealthyNCT02505438
Application of Deuterated Water (D2O) to Define the Etiology of Musculoskeletal Decline in Ageing and the Efficacy of Nutritional Supplementation
A study testing Exercise in people with Healthy, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Maintaining muscle mass and function is important in healthy ageing to maintain quality of life. Loss of muscle mass is major problem, as beyond the age ~50, muscle mass declines by ~1-2% a year. To prevent this loss, the investigators need to understand the mechanism regulating muscle mass as we age. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2013to Dec 2015
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Young (18-30y) and old (60-75y) individuals 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 Chronic obstructive pulmonary disease, Hyper/ hypo parathyroidism, hyper/ hypothyroidism,
- Cushing's disease, diabetes
- Active inflammatory bowel disease
- Renal disease
Show all 10Show 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.
Ken Smith, PhD contact
Matthew Brook contact
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Derby Hospital Medical School
Derby, DE22 3DT
Matthew Brook, mzxmb2@nottingham.ac.uk
About this study
Maintaining muscle mass and function is important in healthy ageing to maintain quality of life. Loss of muscle mass is major problem, as beyond the age ~50, muscle mass declines by ~1-2% a year. To prevent this loss, the investigators need to understand the mechanism regulating muscle mass as we age. In this project the investigators aim to determine these mechanisms using a new technique of heavy water ingestion, this allows measurement of multiple aspects of skeletal muscle mass metabolism e.g. protein synthesis, over long periods (6 weeks) as people go about their normal everyday activities. The investigators also aim to determine the influence of resistance exercise training on older muscle, as well as differences between men and women in muscle responses to exercise and nutrition HMB (beta-hydroxy-beta-methylbutyrate).
- Conditions
- Healthy
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Young Unilateral Exercise | Experimental | Young Individuals (18-30y) studied before and after 6 weeks unilateral resistance exercise training Receives: Behavioral: Exercise |
| Old Unilateral Exercise | Experimental | Old individuals (65-75y) studied before and after 6 weeks of unilateral resistance exercise training Receives: Behavioral: Exercise |
| Old Unilateral Exercise and HMB | Experimental | Old individuals (65-75y) studied before and after 6 weeks of unilateral resistance exercise training with HMB (beta-hydroxy-beta-methylbutyrate) supplementation Receives: Behavioral: Exercise |
| Old Unilateral Exercise and Omega 3 | Experimental | Old individuals (65-75y) studied before and after 6 weeks of unilateral resistance exercise training with Omega 3 supplementation Receives: Behavioral: 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 and supplementation
Measured: 0-6 Weeks
Muscle Strength
Maximal voluntary contractions of the quadriceps will be performed (leg extension) in the trained and untrained legs. This will be performed at baseline and repeated throughout to monitor training progression
Measured: 0-6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startApr 2013
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- The Dunhill Medical Trust
- Responsible party
- Sponsor
- Investigators
- Ken Smith, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505438
- Sponsor's protocol ID
- DMTD2O13
- Status last verified
- Dec 2015
- First submitted
- 8 May 2015
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Deuterated Water (D2O) to Define the Etiology of Musculoskeletal Decline in Ageing and the Efficacy of Nutritional Supplementation
- ClinicalTrials.gov ID
- NCT02505438
- Acronym / sponsor ID
- DMTD2O13
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- The Dunhill Medical Trust
- Study start
- Apr 2013
- Primary completion
- Dec 2015 (estimated)
- First posted
- 22 Jul 2015 (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.
Maintaining muscle mass and function is important in healthy ageing to maintain quality of life. Loss of muscle mass is major problem, as beyond the age ~50, muscle mass declines by ~1-2% a year. To prevent this loss, the investigators need to understand the mechanism regulating muscle mass as we age. In this project the investigators aim to determine these mechanisms using a new technique of heavy water ingestion, this allows measurement of multiple aspects of skeletal muscle mass metabolism e.g. protein synthesis, over long periods (6 weeks) as people go about their normal everyday activities. The investigators also aim to determine the influence of resistance exercise training on older muscle, as well as differences between men and women in muscle responses to exercise and nutrition HMB (beta-hydroxy-beta-methylbutyrate).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Young Unilateral Exercise | Experimental | Behavioral: ExerciseYoung Individuals (18-30y) studied before and after 6 weeks unilateral resistance exercise training |
| Old Unilateral Exercise | Experimental | Behavioral: ExerciseOld individuals (65-75y) studied before and after 6 weeks of unilateral resistance exercise training |
| Old Unilateral Exercise and HMB | Experimental | Behavioral: ExerciseOld individuals (65-75y) studied before and after 6 weeks of unilateral resistance exercise training with HMB (beta-hydroxy-beta-methylbutyrate) supplementation |
| Old Unilateral Exercise and Omega 3 | Experimental | Behavioral: ExerciseOld individuals (65-75y) studied before and after 6 weeks of unilateral resistance exercise training with Omega 3 supplementation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Young (18-30y) and old (60-75y) individuals who are generally healthy and recreationally active
Key exclusion criteria (10 listed)
- Active cardiovascular disease
- Cerebrovascular disease including previous stroke, aneurysm (large vessel or intracranial)
- Respiratory disease including pulmonary hypertension or Chronic obstructive pulmonary disease, 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 |
|---|---|---|
| Exercise | Behavioural | Old Unilateral Exercise, Old Unilateral Exercise and HMB, Old Unilateral Exercise and Omega 3, 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 and supplementation
Muscle Strength
Time frame: 0-6 Weeks
Maximal voluntary contractions of the quadriceps will be performed (leg extension) in the trained and untrained legs. This will be performed at baseline and repeated throughout to monitor training progression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
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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.
Ken Smith, PhD contact
Matthew Brook contact
Ken Smith, PhD 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 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 10 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: status not confirmed, as of the sponsor's last update on 9 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ken Smith, PhD (ken.Smith@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Protein Synthesis (time frame: 0-6 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2015.