Application of Deuterated Water (D2O) to Define the Etiology of Musculoskeletal Decline in Ageing and the Efficacy of Nutritional Supplementation

Healthy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02505438
• Other study ID #: DMTD2O13
• Status: Recruiting
• Phase: N/A
• First received: May 8, 2015
• Last updated: December 8, 2015
• Start date: April 2013

Study information

• Verified date: December 2015
• Source: University of Nottingham
• Contact: Ken Smith, PhD
• Email: ken.Smith[@]nottingham.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Young (18-30y) and old (60-75y) individuals 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 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• Exercise

Locations

Country	Name	City	State
United Kingdom	Royal Derby Hospital Medical School	Derby

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	The Dunhill Medical Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No