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Oxidative Stress Links Aging, Activity, and Mobility Limitation

Primary Purpose

Aging

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vitamins C, E, and alpha lipoic acid
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aging focused on measuring Oxidative Stress, Free radicals, Aging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Arm 1

    Arm 2

    Arm Description

    Young healthy men and women aged 18-30

    Older healthy men and women aged >70.

    Outcomes

    Primary Outcome Measures

    Vascular Function (i.e. % Flow Mediated Vasodilation)
    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)
    Free radicals and levels of lipid peroxidation were measured using electron paramagnetic spectroscopy and ELISA assays. A minimum value is 0 and a maximum value is 10. A higher value is a worse outcome.
    Vascular Function Following the Antioxidant Intervention
    The degree of vasodilation following the antioxidant intervention measured by Doppler ultrasound.

    Full Information

    First Posted
    July 30, 2010
    Last Updated
    October 9, 2018
    Sponsor
    VA Office of Research and Development
    Collaborators
    University of Utah
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01177189
    Brief Title
    Oxidative Stress Links Aging, Activity, and Mobility Limitation
    Official Title
    Oxidative Stress Links Aging, Activity and Mobility Limitation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Terminated
    Why Stopped
    Inadequate effect size.
    Study Start Date
    July 1, 2011 (Actual)
    Primary Completion Date
    July 3, 2017 (Actual)
    Study Completion Date
    July 3, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    VA Office of Research and Development
    Collaborators
    University of Utah

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aging
    Keywords
    Oxidative Stress, Free radicals, Aging

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    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
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    87 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 1
    Arm Type
    Other
    Arm Description
    Young healthy men and women aged 18-30
    Arm Title
    Arm 2
    Arm Type
    Other
    Arm Description
    Older healthy men and women aged >70.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Vitamins C, E, and alpha lipoic acid
    Intervention Description
    Oral antioxidant cocktail or placebo to be consumed daily
    Primary Outcome Measure Information:
    Title
    Vascular Function (i.e. % Flow Mediated Vasodilation)
    Description
    The effect on flow mediated vasodilation is measured using Doppler ultrasound.
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Exercise-induced Oxidative Stress (i.e. Free Radical Concentrations and Levels of Lipid Peroxidation)
    Description
    Free radicals and levels of lipid peroxidation were measured using electron paramagnetic spectroscopy and ELISA assays. A minimum value is 0 and a maximum value is 10. A higher value is a worse outcome.
    Time Frame
    8 weeks
    Title
    Vascular Function Following the Antioxidant Intervention
    Description
    The degree of vasodilation following the antioxidant intervention measured by Doppler ultrasound.
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Russell S Richardson, PhD
    Organizational Affiliation
    VA Salt Lake City Health Care System, Salt Lake City, UT
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Oxidative Stress Links Aging, Activity, and Mobility Limitation

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