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Oxidative Stress Links Aging, Activity, and Mobility Limitation

This study has been terminated.
(Inadequate effect size.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01177189
First Posted: August 6, 2010
Last Update Posted: September 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Utah
Information provided by (Responsible Party):
VA Office of Research and Development
  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
Aging Dietary Supplement: Vitamins C, E, and alpha lipoic acid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Participants will consume either a daily oral antioxidant cocktail or a placebo. The oral antioxidant cocktail consists of vitamin C, vitamin E, and alpha lipoic acid.
Masking: Triple (Participant, 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 VA Office of Research and Development:

Primary Outcome Measures:
  • Vascular Function (i.e. % flow mediated vasodilation) [ Time Frame: 8 weeks ]
    The effect on flow mediated vasodilation is measured using Doppler ultrasound.


Secondary Outcome Measures:
  • Exercise-induced oxidative stress (i.e. free radical concentrations and levels of lipid peroxidation) [ Time Frame: 8 weeks ]
    Free radicals and levels of lipid peroxidation were measured using electron paramagnetic spectroscopy and ELISA assays.

  • Exercise-induced adaptations in vascular function (i.e. % flow mediated vasodilation) [ Time Frame: 8 weeks ]
    The degree of exercise-induced adaptation is measured by its effect on flow mediated vasodilation using Doppler ultrasound.


Enrollment: 111
Actual Study Start Date: July 1, 2011
Study Completion Date: July 3, 2017
Primary Completion Date: July 3, 2017 (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 the investigators' 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01177189


Sponsors and Collaborators
VA Office of Research and Development
University of Utah
Investigators
Principal Investigator: Russell S Richardson, PhD VA Salt Lake City Health Care System, Salt Lake City, UT
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01177189     History of Changes
Other Study ID Numbers: E6910-R
First Submitted: July 30, 2010
First Posted: August 6, 2010
Last Update Posted: September 21, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Oxidative Stress
Free radicals
Aging

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