The Effects of Vitamin E and Vitamin C and Exercise

Sponsor

USDA Grand Forks Human Nutrition Research Center (U.S. Fed)

Overall Status

Terminated

CT.gov ID

NCT01369043

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Exercise and Non-exercise Effect Upon Vitamins E and C	Dietary Supplement: Vitamin E and Vitamin C	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

May 1, 2011

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

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

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

Outcome Measures

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. [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 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. [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. [28 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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