Application of Deuterated Water (D2O) to Define the Etiology of Musculoskeletal Decline in Ageing and the Efficacy of Nutritional Supplementation
1 other identifier
interventional
48
1 country
1
Brief 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. 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 8, 2015
CompletedFirst Posted
Study publicly available on registry
July 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedDecember 9, 2015
December 1, 2015
2.7 years
May 8, 2015
December 8, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Muscle Protein Synthesis
Comparison of muscle protein synthesis between young and older individuals and in response to 6 weeks unilateral exercise training and supplementation
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
0-6 Weeks
Study Arms (4)
Young Unilateral Exercise
EXPERIMENTALYoung Individuals (18-30y) studied before and after 6 weeks unilateral resistance exercise training
Old Unilateral Exercise
EXPERIMENTALOld individuals (65-75y) studied before and after 6 weeks of unilateral resistance exercise training
Old Unilateral Exercise and HMB
EXPERIMENTALOld 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
EXPERIMENTALOld individuals (65-75y) studied before and after 6 weeks of unilateral resistance exercise training with Omega 3 supplementation
Interventions
Eligibility Criteria
You may qualify if:
- Young (18-30y) and old (60-75y) individuals who are generally healthy and recreationally active
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Nottinghamlead
- The Dunhill Medical Trustcollaborator
Study Sites (1)
Royal Derby Hospital Medical School
Derby, DE22 3DT, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ken Smith, PhD
University of Nottingham
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2015
First Posted
July 22, 2015
Study Start
April 1, 2013
Primary Completion
December 1, 2015
Last Updated
December 9, 2015
Record last verified: 2015-12