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The Effects of Vitamin E and Vitamin C and Exercise

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01369043
First received: June 6, 2011
Last updated: August 21, 2012
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention
Exercise and Non-exercise Effect Upon Vitamins E and C
 Dietary Supplement: Vitamin E and Vitamin C

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: Modulation of Insulin and Exercise Responses by Vitamin E and Vitamin C

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by USDA Grand Forks Human Nutrition Research Center:

Primary Outcome 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 ] [ Designated as safety issue: No ]
    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 Outcome 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 ] [ Designated as safety issue: No ]
  • (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 ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: May 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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
No Intervention: Placebo
Placebos instead of the Vitamin E and Vitamin C supplements

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.

  Eligibility

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01369043

Locations
United States, North Dakota
Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, United States, 58201
Sponsors and Collaborators
USDA Grand Forks Human Nutrition Research Center
Investigators
Principal Investigator: Matthew Picklo, PhD Agriculture Research Service, United States Department of Agriculture, Grand Forks Human Nutrition Research Center
  More Information

Additional Information:
Click here for information about this study: Modulation of Insulin and Exercise Responses by Vitamin E and Vitamin C  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01369043     History of Changes
Other Study ID Numbers: GFHNRC503
Study First Received: June 6, 2011
Last Updated: August 21, 2012
Health Authority: United States: Federal Government

Keywords provided by USDA Grand Forks Human Nutrition Research Center:
Vitamin E
Vitamin C
Exercise
Antioxidant

Additional relevant MeSH terms:
Ascorbic Acid
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Antioxidants
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013