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

December 8, 2015 updated by: University of Nottingham
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

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 Contact

Study Contact Backup

Study Locations

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

Yes

Genders Eligible for Study

All

Description

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 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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
Behavioral: Exercise
Experimental: Young Unilateral Exercise
Young Individuals (18-30y) studied before and after 6 weeks unilateral resistance exercise training
Behavioral: Exercise
Experimental: Old Unilateral Exercise and HMB
Old individuals (65-75y) studied before and after 6 weeks of unilateral resistance exercise training with HMB (beta-hydroxy-beta-methylbutyrate) supplementation
Behavioral: Exercise
Experimental: Old Unilateral Exercise and Omega 3
Old individuals (65-75y) studied before and after 6 weeks of unilateral resistance exercise training with Omega 3 supplementation
Behavioral: Exercise

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 and supplementation
0-6 Weeks
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
0-6 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Collaborators

The Dunhill Medical Trust

Investigators

  • Principal Investigator: Ken Smith, PhD, 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

April 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

May 8, 2015

First Submitted That Met QC Criteria

July 21, 2015

First Posted (Estimate)

July 22, 2015

Study Record Updates

Last Update Posted (Estimate)

December 9, 2015

Last Update Submitted That Met QC Criteria

December 8, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • DMTD2O13

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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