Oxidative Stress Links Aging, Activity, and Mobility Limitation

NCT01177189 | Terminated Results DMC

• 1 other identifier: E6910-R
• Study Type: interventional
• Target: 87
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Aging

Keywords

Oxidative Stress; Free radicals; Aging

Outcome Measures

Primary Outcomes (1)

• Vascular Function (i.e. % Flow Mediated Vasodilation)

  The effect on flow mediated vasodilation is measured using Doppler ultrasound.

  8 weeks

Secondary Outcomes (2)

• Exercise-induced Oxidative Stress (i.e. Free Radical Concentrations and Levels of Lipid Peroxidation)

  8 weeks

• Vascular Function Following the Antioxidant Intervention

  8 weeks

Study Arms (2)

Arm 1

OTHER

Young healthy men and women aged 18-30

Dietary Supplement: Vitamins C, E, and alpha lipoic acid

Arm 2

OTHER

Older healthy men and women aged \>70.

Dietary Supplement: Vitamins C, E, and alpha lipoic acid

Interventions

Vitamins C, E, and alpha lipoic acid DIETARY_SUPPLEMENT

Oral antioxidant cocktail or placebo to be consumed daily

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Utah: collaborator

MeSH Terms

Interventions

Thioctic Acid

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Results Point of Contact

• Title: Van Reese
• Organization: Salt Lake City VAMC

van.reese@hsc.utah.edu

801 582 1565

Study Officials

• Russell S Richardson, PhD

  VA Salt Lake City Health Care System, Salt Lake City, UT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 30, 2010
• First Posted: August 6, 2010
• Study Start: July 1, 2011
• Primary Completion: July 3, 2017
• Study Completion: July 3, 2017
• Last Updated: February 21, 2019
• Results First Posted: February 21, 2019

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share