Oxidative Stress Links Aging, Activity and Mobility Limitation

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Department of Veterans Affairs
Sponsor:
Collaborator:
University of Utah
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01177189
First received: July 30, 2010
Last updated: October 14, 2014
Last verified: October 2014
  Purpose

The purpose of this study is to understand why and how oxidative stress negatively impacts mobility in the elderly, and to determine whether antioxidant supplements can increase vascular health and mobility.


Condition Intervention Phase
Aging
Dietary Supplement: Vitamins C, E, and alpha lipoic acid
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oxidative Stress Links Aging, Activity and Mobility Limitation

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Vascular Function (i.e. % flow mediated vasodilation) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exercise-induced oxidative stress (i.e. free radical concentrations and levels of lipid peroxidation) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Exercise-induced adaptations in vascular function (i.e. % flow mediated vasodilation) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: July 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
Young healthy men and women aged 18-30
Dietary Supplement: Vitamins C, E, and alpha lipoic acid
Oral antioxidant cocktail or placebo to be consumed daily
Arm 2
Older healthy men and women aged >70.
Dietary Supplement: Vitamins C, E, and alpha lipoic acid
Oral antioxidant cocktail or placebo to be consumed daily

Detailed Description:

With the premise that U.S. Veteran demographics reveal an aging population with significant mobility limitation and oxidative stress is tightly linked to both of these characteristics, a series of skeletal muscle/vascular studies are proposed. Specifically, in a series of recent studies our group has documented positive vascular consequences of antioxidant supplementation during exercise in older subjects that negatively impacted young people. Further provocative findings revealed that following exercise training the older subjects were now also negatively impacted by the antioxidant supplementation. These findings have implications for the understanding of the complex balance between the positive effects of exercise-based rehabilitation, exercise induced oxidative stress, aging, frailty, and subsequent mobility limitation. Therefore four specific aims are proposed that will answer the questions of where (I) oxidative stress is most prevalent in the elderly, why (II) oxidative stress occurs in the elderly, what (III) are the acute consequences of oxidative stress in the elderly, and finally how (IV) can exercise-induced oxidative stress as the result of exercise training in elderly be appropriately managed with exogenous antioxidant therapy to promote compliance and the positive outcome of increased mobility.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy men and women aged either between 18 - 30 years (young group) and >70 years (old group)
  • Free of overt disease. Subjects will be non-obese (BMI < 30) and have plasma glucose concentrations < 7.0 mmol/L under fasting conditions and < 11.1 mmol/L at 120 minutes of an oral glucose tolerance test (OGTT)
  • Subjects will be sedentary, defined here as no regular physical activity for at least the prior 2 years
  • Candidates must have no orthopedic limitations that would prohibit them from performing cycle or knee-extensor exercise
  • All women will be postmenopausal (either natural or surgical) defined as a cessation of menses for at least 2 years, and in women without a uterus, follicle stimulating hormone (FSH) > 40 IU/L

Exclusion Criteria:

  • Candidates demonstrating dyslipidemia based on the National Cholesterol Education Program Guidelines of plasma total cholesterol > 240 mg/dl with LDL-cholesterol > 160 mg/dl will be excluded from participation
  • Candidates who smoke or are taking medications (blood pressure medications, statins, antioxidants etc.) that could influence the results of the study will not be eligible
  • In terms of diet, subjects will be asked to maintain a dietary record for one week prior to the pre-screening and if this reveals a diet that differs substantially from the "typical" average diet in both the young and old, the subject will not be eligible
  • Women currently taking hormone replacement therapy (HRT) in the preceding year will be excluded from the proposed studies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01177189

Contacts
Contact: Amy Rogers (801) 582-1565 amy.rogers@hsc.utah.edu
Contact: Van R Reese, BS MS (801) 582-1565 ext 4335 van.reese@hsc.utah.edu

Locations
United States, Utah
VA Salt Lake City Health Care System, Salt Lake City Recruiting
Salt Lake City, Utah, United States, 84148
Contact: Amy Rogers    801-582-1565    amy.rogers@hsc.utah.edu   
Principal Investigator: Russell Richardson, PhD         
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Russell Richardson, PhD VA Salt Lake City Health Care System, Salt Lake City
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01177189     History of Changes
Other Study ID Numbers: E6910-R
Study First Received: July 30, 2010
Last Updated: October 14, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Oxidative Stress
Free radicals
Aging

Additional relevant MeSH terms:
Mobility Limitation
Signs and Symptoms
Thioctic Acid
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on October 22, 2014