The Effects of Vitamin E and Vitamin C and Exercise

Overview

Moderate exercise is thought to be one of the best known means to improve how insulin works in people. Taking vitamin C and vitamin E is also thought to have the same effect. This study is being done to see if taking vitamin C and vitamin E improves or hinders how insulin works when people do not exercise and when they do exercise.

Full Title of Study: “Modulation of Insulin and Exercise Responses by Vitamin E and Vitamin C”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: March 2012

Detailed Description

The objective of the study is to determine in humans whether anti-oxidant supplementation with ascorbate (vitamin C) or R,R,R-α-tocopherol acetate (vitamin E) improves insulin sensitivity in the untrained state but blocks exercise-induced increases in insulin sensitivity and other adaptations to exercise. The results will provide new information on the roles of anti-oxidant supplementation in modifying insulin sensitivity, and will inform guidelines for anti-oxidant supplementation as an adjunct to exercise.

Interventions

  • Dietary Supplement: Vitamin E and Vitamin C
    • Vitamin E 400 iu/dose daily times 56 days Vitamin C 500 mg/dose twice daily times 56 days

Arms, Groups and Cohorts

  • Active Comparator: Vitamin E and Vitamin C
    • 4 weeks with Vitamin E and Vitamin C supplementation with no exercise and 4 weeks of supplementation with prescribed exercise.
  • No Intervention: Placebo
    • Placebos instead of the Vitamin E and Vitamin C supplements

Clinical Trial Outcome Measures

Primary Measures

  • (1) Blood glucose and insulin following glucose challenge in non-exercising and exercising people (BMI 27 to 35) taking anti-oxidants (vitamin E and vitamin C) or placebo.
    • Time Frame: 28 weeks
    • Individuals will be in placebo and vitamin supplemented groups in a cross-over design. A total of 6 oral glucose tolerance tests will be performed per subject in the study.

Secondary Measures

  • (1) Resting metabolic rate, body composition, plasma oxidative stress, plasma vitamin E and vitamin C levels in non-exercising and exercising people (BMI 27 to 35) taking anti-oxidants (vitamin E and vitamin C) or placebo.
    • Time Frame: 28 weeks
  • (2) Fitness measures (heart rate, exercise work, VO2, VCO2, blood lactate) in non-exercising and exercising people (BMI 27 to 35) taking anti-oxidants (vitamin E and vitamin C) or placebo.
    • Time Frame: 28 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • 30 to 50 years of age
  • Willing to not change eating habits
  • Willing to not change physical activity habits
  • Willing to complete the 28 week study
  • Able to swallow pills

Exclusion Criteria

  • smoke or use tobacco or nicotine in any form including snuff, pills, and patches
  • take any medication that makes you unable to do hard exercise
  • have cardiovascular, pulmonary, and/or a metabolic disease such as diabetes
  • have uncontrolled high blood pressure
  • have alcohol, anabolic steroids, or other substance abuse issues
  • consume more than 3 alcoholic drinks/week
  • have any joint or muscle injuries that affects your ability to exercise
  • have cancer (other than skin cancer or carcinoma in situ of the cervix)
  • are pregnant or nursing

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • USDA Grand Forks Human Nutrition Research Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Matthew Picklo, PhD, Principal Investigator, Agriculture Research Service, United States Department of Agriculture, Grand Forks Human Nutrition Research Center

References

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