The Effects of Vitamin E and Vitamin C and Exercise
6 mars 2015 mis à jour par: 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.
Aperçu de l'étude
Statut
Résilié
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
1
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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North Dakota
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Grand Forks, North Dakota, États-Unis, 58201
- Grand Forks Human Nutrition Research Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
30 ans à 50 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: 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.
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Vitamin E 400 iu/dose daily times 56 days Vitamin C 500 mg/dose twice daily times 56 days
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Aucune intervention: Placebo
Placebos instead of the Vitamin E and Vitamin C supplements
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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(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.
Délai: 28 weeks
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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.
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28 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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(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.
Délai: 28 weeks
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28 weeks
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(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.
Délai: 28 weeks
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28 weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Matthew Picklo, PhD, Agriculture Research Service, United States Department of Agriculture, Grand Forks Human Nutrition Research Center
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Bailey DM, Young IS, McEneny J, Lawrenson L, Kim J, Barden J, Richardson RS. Regulation of free radical outflow from an isolated muscle bed in exercising humans. Am J Physiol Heart Circ Physiol. 2004 Oct;287(4):H1689-99. doi: 10.1152/ajpheart.00148.2004. Epub 2004 May 20.
- Mastaloudis A, Leonard SW, Traber MG. Oxidative stress in athletes during extreme endurance exercise. Free Radic Biol Med. 2001 Oct 1;31(7):911-22. doi: 10.1016/s0891-5849(01)00667-0.
- Mastaloudis A, Morrow JD, Hopkins DW, Devaraj S, Traber MG. Antioxidant supplementation prevents exercise-induced lipid peroxidation, but not inflammation, in ultramarathon runners. Free Radic Biol Med. 2004 May 15;36(10):1329-41. doi: 10.1016/j.freeradbiomed.2004.02.069.
- Mastaloudis A, Traber MG, Carstensen K, Widrick JJ. Antioxidants did not prevent muscle damage in response to an ultramarathon run. Med Sci Sports Exerc. 2006 Jan;38(1):72-80. doi: 10.1249/01.mss.0000188579.36272.f6.
- Mastaloudis A, Yu TW, O'Donnell RP, Frei B, Dashwood RH, Traber MG. Endurance exercise results in DNA damage as detected by the comet assay. Free Radic Biol Med. 2004 Apr 15;36(8):966-75. doi: 10.1016/j.freeradbiomed.2004.01.012.
- Ristow M, Zarse K, Oberbach A, Kloting N, Birringer M, Kiehntopf M, Stumvoll M, Kahn CR, Bluher M. Antioxidants prevent health-promoting effects of physical exercise in humans. Proc Natl Acad Sci U S A. 2009 May 26;106(21):8665-70. doi: 10.1073/pnas.0903485106. Epub 2009 May 11.
- Gomez-Cabrera MC, Domenech E, Romagnoli M, Arduini A, Borras C, Pallardo FV, Sastre J, Vina J. Oral administration of vitamin C decreases muscle mitochondrial biogenesis and hampers training-induced adaptations in endurance performance. Am J Clin Nutr. 2008 Jan;87(1):142-9. doi: 10.1093/ajcn/87.1.142.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mai 2011
Achèvement primaire (Réel)
1 mars 2012
Achèvement de l'étude (Réel)
1 mars 2012
Dates d'inscription aux études
Première soumission
6 juin 2011
Première soumission répondant aux critères de contrôle qualité
7 juin 2011
Première publication (Estimation)
8 juin 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
9 mars 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 mars 2015
Dernière vérification
1 mars 2015
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- GFHNRC503
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .