The Effects of Vitamin E and Vitamin C and Exercise

March 6, 2015 updated by: USDA Grand Forks Human Nutrition Research Center

Modulation of Insulin and Exercise Responses by Vitamin E and Vitamin C

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Dakota
      • Grand Forks, North Dakota, United States, 58201
        • Grand Forks Human Nutrition Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(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.
28 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
(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
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
28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

June 6, 2011

First Submitted That Met QC Criteria

June 7, 2011

First Posted (Estimate)

June 8, 2011

Study Record Updates

Last Update Posted (Estimate)

March 9, 2015

Last Update Submitted That Met QC Criteria

March 6, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GFHNRC503

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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