Exercise and Non-exercise Effect Upon Vitamins E and CNCT01369043

The Effects of Vitamin E and Vitamin C and Exercise

A study testing Vitamin E and Vitamin C in people with Exercise and Non-exercise Effect Upon Vitamins E and C, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 30 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Exercise and Non-exercise Effect Upon Vitamins E and C
What is being tested?: Vitamin E and Vitamin C
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteUnited States
Study dates: May 2011to Mar 2012
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58201

Other trials in United States

About this study

Official title: Modulation of Insulin and Exercise Responses by Vitamin E and Vitamin C

Read the 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.

Conditions: Exercise and Non-exercise Effect Upon Vitamins E and C
Being tested: Vitamin E and Vitamin C
Keywords: Vitamin E, Vitamin C, Exercise, Antioxidant
Medical subject headings: Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vitamin E and Vitamin CDietary supplement
Vitamin E 400 iu/dose daily times 56 days Vitamin C 500 mg/dose twice daily times 56 days

Study groups in NCT01369043
Study group	Role	What they receive
Vitamin E and Vitamin C	Active comparator	4 weeks with Vitamin E and Vitamin C supplementation with no exercise and 4 weeks of supplementation with prescribed exercise. Receives: Dietary Supplement: Vitamin E and Vitamin C
Placebo	No intervention	Placebos instead of the Vitamin E and Vitamin C supplements

What is being measured

The primary outcome is the main question the study is designed to answer.

(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.
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.
Measured: 28 weeks

Secondary outcomes (2)

(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.
Measured: 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.
Measured: 28 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Mar 2012

First posted8 Jun 2011 (estimated)
Study startMay 2011
Primary completionMar 2012
Study completionMar 2012

Why it stopped: Lack of successful recruiting, budget cuts, and potential study flaws.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (22)Papers the sponsor has linked to this study.
Other trials for Exercise and Non-exercise Effect Upon Vitamins E and CStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01369043
Sponsor's protocol ID: GFHNRC503
Status last verified: Mar 2015
First submitted: 6 Jun 2011
Last updated: 9 Mar 2015
Results posted: No
Data monitoring committee: Yes

Publications

Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
PubMed 11832527
Hathcock JN, Azzi A, Blumberg J, Bray T, Dickinson A, Frei B, Jialal I, Johnston CS, Kelly FJ, Kraemer K, Packer L, Parthasarathy S, Sies H, Traber MG. Vitamins E and C are safe across a broad range of intakes. Am J Clin Nutr. 2005 Apr;81(4):736-45. doi: 10.1093/ajcn/81.4.736.
PubMed 15817846
Devaraj S, Leonard S, Traber MG, Jialal I. Gamma-tocopherol supplementation alone and in combination with alpha-tocopherol alters biomarkers of oxidative stress and inflammation in subjects with metabolic syndrome. Free Radic Biol Med. 2008 Mar 15;44(6):1203-8. doi: 10.1016/j.freeradbiomed.2007.12.018. Epub 2007 Dec 23.
PubMed 18191645
Vincent HK, Bourguignon CM, Weltman AL, Vincent KR, Barrett E, Innes KE, Taylor AG. Effects of antioxidant supplementation on insulin sensitivity, endothelial adhesion molecules, and oxidative stress in normal-weight and overweight young adults. Metabolism. 2009 Feb;58(2):254-62. doi: 10.1016/j.metabol.2008.09.022.
PubMed 19154960
Furukawa S, Fujita T, Shimabukuro M, Iwaki M, Yamada Y, Nakajima Y, Nakayama O, Makishima M, Matsuda M, Shimomura I. Increased oxidative stress in obesity and its impact on metabolic syndrome. J Clin Invest. 2004 Dec;114(12):1752-61. doi: 10.1172/JCI21625.
PubMed 15599400
Gletsu-Miller N, Hansen JM, Jones DP, Go YM, Torres WE, Ziegler TR, Lin E. Loss of total and visceral adipose tissue mass predicts decreases in oxidative stress after weight-loss surgery. Obesity (Silver Spring). 2009 Mar;17(3):439-46. doi: 10.1038/oby.2008.542. Epub 2008 Dec 11.
PubMed 19219062
Manning PJ, Sutherland WH, Walker RJ, de Jong SA, Berry EA. The effect of glucose ingestion on inflammation and oxidative stress in obese individuals. Metabolism. 2008 Oct;57(10):1345-9. doi: 10.1016/j.metabol.2008.04.020.
PubMed 18803936
Manning PJ, Sutherland WH, Walker RJ, Williams SM, de Jong SA, Berry EA. The effect of rosiglitazone on oxidative stress and insulin resistance in overweight individuals. Diabetes Res Clin Pract. 2008 Aug;81(2):209-15. doi: 10.1016/j.diabres.2008.04.015. Epub 2008 Jun 9.
PubMed 18541328
Sutherland WH, Manning PJ, Walker RJ, de Jong SA, Ryalls AR, Berry EA. Vitamin E supplementation and plasma 8-isoprostane and adiponectin in overweight subjects. Obesity (Silver Spring). 2007 Feb;15(2):386-91. doi: 10.1038/oby.2007.546.
PubMed 17299112
Manning PJ, Sutherland WH, Walker RJ, Williams SM, De Jong SA, Ryalls AR, Berry EA. Effect of high-dose vitamin E on insulin resistance and associated parameters in overweight subjects. Diabetes Care. 2004 Sep;27(9):2166-71. doi: 10.2337/diacare.27.9.2166.
PubMed 15333479
Perticone F, Ceravolo R, Candigliota M, Ventura G, Iacopino S, Sinopoli F, Mattioli PL. Obesity and body fat distribution induce endothelial dysfunction by oxidative stress: protective effect of vitamin C. Diabetes. 2001 Jan;50(1):159-65. doi: 10.2337/diabetes.50.1.159.
PubMed 11147782
Chen H, Karne RJ, Hall G, Campia U, Panza JA, Cannon RO 3rd, Wang Y, Katz A, Levine M, Quon MJ. High-dose oral vitamin C partially replenishes vitamin C levels in patients with Type 2 diabetes and low vitamin C levels but does not improve endothelial dysfunction or insulin resistance. Am J Physiol Heart Circ Physiol. 2006 Jan;290(1):H137-45. doi: 10.1152/ajpheart.00768.2005. Epub 2005 Aug 26.
PubMed 16126809
Rizzo MR, Abbatecola AM, Barbieri M, Vietri MT, Cioffi M, Grella R, Molinari A, Forsey R, Powell J, Paolisso G. Evidence for anti-inflammatory effects of combined administration of vitamin E and C in older persons with impaired fasting glucose: impact on insulin action. J Am Coll Nutr. 2008 Aug;27(4):505-11. doi: 10.1080/07315724.2008.10719732.
PubMed 18978171
Bailey DM, Davies B, Young IS, Jackson MJ, Davison GW, Isaacson R, Richardson RS. EPR spectroscopic detection of free radical outflow from an isolated muscle bed in exercising humans. J Appl Physiol (1985). 2003 May;94(5):1714-8. doi: 10.1152/japplphysiol.01024.2002. Epub 2003 Mar 7.
PubMed 12626489
Bailey DM, Lawrenson L, McEneny J, Young IS, James PE, Jackson SK, Henry RR, Mathieu-Costello O, McCord JM, Richardson RS. Electron paramagnetic spectroscopic evidence of exercise-induced free radical accumulation in human skeletal muscle. Free Radic Res. 2007 Feb;41(2):182-90. doi: 10.1080/10715760601028867.
PubMed 17364944

Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Modulation of Insulin and Exercise Responses by Vitamin E and Vitamin C
ClinicalTrials.gov ID: NCT01369043
Acronym / sponsor ID: GFHNRC503
Conditions: Exercise and Non-exercise Effect Upon Vitamins E and C
Keywords: Vitamin E, Vitamin C, Exercise, Antioxidant
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of successful recruiting, budget cuts, and potential study flaws.
Enrolment: 1 participants (actual)
Lead sponsor: USDA Grand Forks Human Nutrition Research CenterUS federal agency
Study start: May 2011
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 8 Jun 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Vitamin E and Vitamin C	Active comparator	Dietary Supplement: Vitamin E and Vitamin C4 weeks with Vitamin E and Vitamin C supplementation with no exercise and 4 weeks of supplementation with prescribed exercise.
Placebo	No intervention	–Placebos instead of the Vitamin E and Vitamin C supplements

Who may qualify

Ages: 30 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vitamin E and Vitamin CVitamin E 400 iu/dose daily times 56 days Vitamin C 500 mg/dose twice daily times 56 days	Dietary supplement	Vitamin E and Vitamin C

Primary outcome

(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.

2 secondary outcomes

(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

Results and safety

The study was stopped early (reason given: Lack of successful recruiting, budget cuts, and potential study flaws.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2015.
Background: PubMed 11832527Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
Background: PubMed 15817846Hathcock JN, Azzi A, Blumberg J, Bray T, Dickinson A, Frei B, Jialal I, Johnston CS, Kelly FJ, Kraemer K, Packer L, Parthasarathy S, Sies H, Traber MG. Vitamins E and C are safe across a broad range of intakes. Am J Clin Nutr. 2005 Apr;81(4):736-45. doi: 10.1093/ajcn/81.4.736.
Background: PubMed 18191645Devaraj S, Leonard S, Traber MG, Jialal I. Gamma-tocopherol supplementation alone and in combination with alpha-tocopherol alters biomarkers of oxidative stress and inflammation in subjects with metabolic syndrome. Free Radic Biol Med. 2008 Mar 15;44(6):1203-8. doi: 10.1016/j.freeradbiomed.2007.12.018. Epub 2007 Dec 23.
Background: PubMed 19154960Vincent HK, Bourguignon CM, Weltman AL, Vincent KR, Barrett E, Innes KE, Taylor AG. Effects of antioxidant supplementation on insulin sensitivity, endothelial adhesion molecules, and oxidative stress in normal-weight and overweight young adults. Metabolism. 2009 Feb;58(2):254-62. doi: 10.1016/j.metabol.2008.09.022.
Background: PubMed 15599400Furukawa S, Fujita T, Shimabukuro M, Iwaki M, Yamada Y, Nakajima Y, Nakayama O, Makishima M, Matsuda M, Shimomura I. Increased oxidative stress in obesity and its impact on metabolic syndrome. J Clin Invest. 2004 Dec;114(12):1752-61. doi: 10.1172/JCI21625.
Background: PubMed 19219062Gletsu-Miller N, Hansen JM, Jones DP, Go YM, Torres WE, Ziegler TR, Lin E. Loss of total and visceral adipose tissue mass predicts decreases in oxidative stress after weight-loss surgery. Obesity (Silver Spring). 2009 Mar;17(3):439-46. doi: 10.1038/oby.2008.542. Epub 2008 Dec 11.
Background: PubMed 18803936Manning PJ, Sutherland WH, Walker RJ, de Jong SA, Berry EA. The effect of glucose ingestion on inflammation and oxidative stress in obese individuals. Metabolism. 2008 Oct;57(10):1345-9. doi: 10.1016/j.metabol.2008.04.020.
Background: PubMed 18541328Manning PJ, Sutherland WH, Walker RJ, Williams SM, de Jong SA, Berry EA. The effect of rosiglitazone on oxidative stress and insulin resistance in overweight individuals. Diabetes Res Clin Pract. 2008 Aug;81(2):209-15. doi: 10.1016/j.diabres.2008.04.015. Epub 2008 Jun 9.
Background: PubMed 17299112Sutherland WH, Manning PJ, Walker RJ, de Jong SA, Ryalls AR, Berry EA. Vitamin E supplementation and plasma 8-isoprostane and adiponectin in overweight subjects. Obesity (Silver Spring). 2007 Feb;15(2):386-91. doi: 10.1038/oby.2007.546.
Background: PubMed 15333479Manning PJ, Sutherland WH, Walker RJ, Williams SM, De Jong SA, Ryalls AR, Berry EA. Effect of high-dose vitamin E on insulin resistance and associated parameters in overweight subjects. Diabetes Care. 2004 Sep;27(9):2166-71. doi: 10.2337/diacare.27.9.2166.
Background: PubMed 11147782Perticone F, Ceravolo R, Candigliota M, Ventura G, Iacopino S, Sinopoli F, Mattioli PL. Obesity and body fat distribution induce endothelial dysfunction by oxidative stress: protective effect of vitamin C. Diabetes. 2001 Jan;50(1):159-65. doi: 10.2337/diabetes.50.1.159.
Background: PubMed 16126809Chen H, Karne RJ, Hall G, Campia U, Panza JA, Cannon RO 3rd, Wang Y, Katz A, Levine M, Quon MJ. High-dose oral vitamin C partially replenishes vitamin C levels in patients with Type 2 diabetes and low vitamin C levels but does not improve endothelial dysfunction or insulin resistance. Am J Physiol Heart Circ Physiol. 2006 Jan;290(1):H137-45. doi: 10.1152/ajpheart.00768.2005. Epub 2005 Aug 26.
Click here for information about this study: Modulation of Insulin and Exercise Responses by Vitamin E and Vitamin CLink provided by the sponsor.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Matthew Picklo, PhD principal investigator

Agriculture Research Service, United States Department of Agriculture, Grand Forks Human Nutrition Research Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin E and Vitamin C in people with Exercise and Non-exercise Effect Upon Vitamins E and C, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Lack of successful recruiting, budget cuts, and potential study flaws.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

(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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01369043, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2015.