Oxidative Stress Links Aging, Activity and Mobility Limitation
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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 |
- Vascular Function (i.e. % flow mediated vasodilation) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- 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 |
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| Contact: Heidi Britton, MS | (801) 582-1565 ext 1495 | heidi.britton@hsc.utah.edu |
| Contact: Van R Reese, BS MS | (801) 582-1565 ext 4335 | van.reese@hsc.utah.edu |
| United States, Utah | |
| VA Salt Lake City Health Care System, Salt Lake City | Recruiting |
| Salt Lake City, Utah, United States, 84148 | |
| Contact: Heidi Britton, MS 801-582-1565 ext 1495 heidi.britton@hsc.utah.edu | |
| Principal Investigator: Russell Richardson, PhD | |
| 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: | June 12, 2013 |
| 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 Ascorbic Acid Thioctic Acid Vitamins Antioxidants Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Protective Agents Physiological Effects of Drugs Micronutrients Growth Substances Vitamin B Complex |
ClinicalTrials.gov processed this record on June 18, 2013