抗氧化维生素和矿物质对健康影响的初级预防试验。
SU.VI.MAX 研究。抗氧化维生素和矿物质对健康影响的随机、安慰剂对照预防试验。
有人提出,饮食中抗氧化维生素和矿物质摄入量低会增加心血管疾病和癌症的发病率。
然而,迄今为止,已发表的关于含有抗氧化营养素的补充剂的随机、安慰剂对照试验的结果尚未提供有益效果的明确证据。
我们测试了营养剂量的补充剂与抗氧化维生素和矿物质的组合在降低一般人群癌症和缺血性心血管疾病发病率方面的功效。
研究概览
详细说明
实验研究表明,自由基可能会引发多种病理过程,并且有人提出,由于其抗氧化能力,β-胡萝卜素、维生素 C、维生素 E、硒和锌等营养素可以防止此类有害影响。 来自横断面、病例对照和前瞻性研究的流行病学数据确实表明,抗氧化维生素和矿物质或富含这些营养素的食物的摄入量与癌症和缺血性心血管疾病 (CVD) 的风险之间存在密切关系。 然而,随机安慰剂对照一级预防试验,其中抗氧化微量营养素单独或成对长期以高剂量给药,未能证明这种潜在的有益作用,其中两项甚至表明有害作用。 观察性研究和这些随机试验之间看似矛盾的结果可以通过以下事实来解释:临床试验中使用的剂量远高于通常饮食摄入量可达到的最高水平,而在观察性研究中发现与最低摄入量相关患癌症和心血管疾病的风险。 事实上,唯一一项确实观察到对总死亡率和癌症发病率产生有益影响的试验使用了几种维生素和矿物质组合的营养剂量,并且是在由于该地区生活条件差而基线微量营养素水平非常低的中国人群中进行的(9).
“Supplementation en VItamines et Minéraux AntioXydants” (SU.VI.MAX) 研究的目的是在一项随机、安慰剂对照试验中测试,充足且均衡的抗氧化营养素摄入量是否会降低癌症和缺血性心脏病的发生率中年一般人群的心血管疾病。
研究类型
介入性
注册
13000
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Paris、法国、75003
- U557 Inserm
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
35年 至 60年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
纳入标准:
- 女性35-60岁,男性45-60岁
- 接受给予安慰剂的可能性并接受参与的限制
- 以前没有定期补充所提供的补充剂中的任何维生素或矿物质
- 没有关于饮食的极端信念或行为
排除标准:
- 可能妨碍积极参与或威胁 5 年生存的疾病
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
研究衡量的是什么?
主要结果指标
结果测量 |
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主要致死性和非致死性缺血性心血管事件
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除基底细胞皮肤癌外的任何类型的癌症
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次要结果测量
结果测量 |
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与健康相关的生活质量
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全因死亡率
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临床状态的中间标准
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生物学状态的中间标准
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人体测量状态的中间标准
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Serge Hercberg, MD, PhD、U557 Inserm (UMR Inserm/Inra/CNAM), Institut Scientifique et Technique de la Nutrition et de l'Alimentation/CNAM
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Hercberg S, Galan P, Preziosi P, Bertrais S, Mennen L, Malvy D, Roussel AM, Favier A, Briancon S. The SU.VI.MAX Study: a randomized, placebo-controlled trial of the health effects of antioxidant vitamins and minerals. Arch Intern Med. 2004 Nov 22;164(21):2335-42. doi: 10.1001/archinte.164.21.2335. Erratum In: Arch Intern Med. 2005 Feb 14;165(3):286.
- Andreeva VA, Peneau S, Julia C, Shivappa N, Hebert JR, Wirth MD, Touvier M, Hercberg S, Galan P, Kesse-Guyot E. The inflammatory potential of the diet is prospectively associated with subjective hearing loss. Eur J Nutr. 2021 Oct;60(7):3669-3678. doi: 10.1007/s00394-021-02531-1. Epub 2021 Mar 18.
- Lecuyer L, Dalle C, Micheau P, Petera M, Centeno D, Lyan B, Lagree M, Galan P, Hercberg S, Rossary A, Demidem A, Vasson MP, Partula V, Deschasaux M, Srour B, Latino-Martel P, Druesne-Pecollo N, Kesse-Guyot E, Durand S, Pujos-Guillot E, Manach C, Touvier M. Untargeted plasma metabolomic profiles associated with overall diet in women from the SU.VI.MAX cohort. Eur J Nutr. 2020 Dec;59(8):3425-3439. doi: 10.1007/s00394-020-02177-5. Epub 2020 Jan 11.
- Lecuyer L, Dalle C, Lyan B, Demidem A, Rossary A, Vasson MP, Petera M, Lagree M, Ferreira T, Centeno D, Galan P, Hercberg S, Deschasaux M, Partula V, Srour B, Latino-Martel P, Kesse-Guyot E, Druesne-Pecollo N, Durand S, Pujos-Guillot E, Touvier M. Plasma Metabolomic Signatures Associated with Long-term Breast Cancer Risk in the SU.VI.MAX Prospective Cohort. Cancer Epidemiol Biomarkers Prev. 2019 Aug;28(8):1300-1307. doi: 10.1158/1055-9965.EPI-19-0154. Epub 2019 Jun 4.
- Assmann KE, Adjibade M, Hercberg S, Galan P, Kesse-Guyot E. Unsaturated Fatty Acid Intakes During Midlife Are Positively Associated with Later Cognitive Function in Older Adults with Modulating Effects of Antioxidant Supplementation. J Nutr. 2018 Dec 1;148(12):1938-1945. doi: 10.1093/jn/nxy206.
- Wiernik E, Lemogne C, Fezeu L, Arnault N, Hercberg S, Kesse-Guyot E, Galan P. Association Between Alexithymia and Risk of Incident Cardiovascular Diseases in the SUpplementation en VItamines et Mineraux AntioXydants (SU.VI.MAX) Cohort. Psychosom Med. 2018 Jun;80(5):460-467. doi: 10.1097/PSY.0000000000000592.
- Assmann KE, Adjibade M, Shivappa N, Hebert JR, Wirth MD, Touvier M, Akbaraly T, Hercberg S, Galan P, Julia C, Kesse-Guyot E. The Inflammatory Potential of the Diet at Midlife Is Associated with Later Healthy Aging in French Adults. J Nutr. 2018 Mar 1;148(3):437-444. doi: 10.1093/jn/nxx061.
- Ruhunuhewa I, Adjibade M, Andreeva VA, Galan P, Hercberg S, Assmann KE, Kesse-Guyot E. Prospective association between body mass index at midlife and healthy aging among French adults. Obesity (Silver Spring). 2017 Jul;25(7):1254-1262. doi: 10.1002/oby.21853. Epub 2017 May 11.
- Adjibade M, Andreeva VA, Lemogne C, Touvier M, Shivappa N, Hebert JR, Wirth MD, Hercberg S, Galan P, Julia C, Assmann KE, Kesse-Guyot E. The Inflammatory Potential of the Diet Is Associated with Depressive Symptoms in Different Subgroups of the General Population. J Nutr. 2017 May;147(5):879-887. doi: 10.3945/jn.116.245167. Epub 2017 Mar 29.
- Walker V, Perret-Guillaume C, Kesse-Guyot E, Agrinier N, Hercberg S, Galan P, Assmann KE, Briancon S, Rotonda C. Effect of Multimorbidity on Health-Related Quality of Life in Adults Aged 55 Years or Older: Results from the SU.VI.MAX 2 Cohort. PLoS One. 2016 Dec 29;11(12):e0169282. doi: 10.1371/journal.pone.0169282. eCollection 2016.
- Kesse-Guyot E, Assmann KE, Andreeva VA, Touvier M, Neufcourt L, Shivappa N, Hebert JR, Wirth MD, Hercberg S, Galan P, Julia C. Long-term association between the dietary inflammatory index and cognitive functioning: findings from the SU.VI.MAX study. Eur J Nutr. 2017 Jun;56(4):1647-1655. doi: 10.1007/s00394-016-1211-3. Epub 2016 Apr 7.
- Adriouch S, Julia C, Kesse-Guyot E, Mejean C, Ducrot P, Peneau S, Donnenfeld M, Deschasaux M, Menai M, Hercberg S, Touvier M, Fezeu LK. Prospective association between a dietary quality index based on a nutrient profiling system and cardiovascular disease risk. Eur J Prev Cardiol. 2016 Oct;23(15):1669-76. doi: 10.1177/2047487316640659. Epub 2016 Mar 21.
- Graffouillere L, Deschasaux M, Mariotti F, Neufcourt L, Shivappa N, Hebert JR, Wirth MD, Latino-Martel P, Hercberg S, Galan P, Julia C, Kesse-Guyot E, Touvier M. The Dietary Inflammatory Index Is Associated with Prostate Cancer Risk in French Middle-Aged Adults in a Prospective Study. J Nutr. 2016 Apr 1;146(4):785-791. doi: 10.3945/jn.115.225623. Epub 2016 Mar 9.
- Graffouillere L, Deschasaux M, Mariotti F, Neufcourt L, Shivappa N, Hebert JR, Wirth MD, Latino-Martel P, Hercberg S, Galan P, Julia C, Kesse-Guyot E, Touvier M. Prospective association between the Dietary Inflammatory Index and mortality: modulation by antioxidant supplementation in the SU.VI.MAX randomized controlled trial. Am J Clin Nutr. 2016 Mar;103(3):878-85. doi: 10.3945/ajcn.115.126243. Epub 2016 Feb 10.
- Deschasaux M, Souberbielle JC, Latino-Martel P, Sutton A, Charnaux N, Druesne-Pecollo N, Galan P, Hercberg S, Le Clerc S, Kesse-Guyot E, Ezzedine K, Touvier M. Weight Status and Alcohol Intake Modify the Association between Vitamin D and Breast Cancer Risk. J Nutr. 2016 Mar;146(3):576-85. doi: 10.3945/jn.115.221481. Epub 2016 Jan 27.
- Kesse-Guyot E, Assmann KE, Andreeva VA, Ferry M, Hercberg S, Galan P; SU.VI.MAX 2 Research Group. Consumption of Dairy Products and Cognitive Functioning: Findings from the SU.VI.MAX 2 Study. J Nutr Health Aging. 2016 Feb;20(2):128-37. doi: 10.1007/s12603-015-0593-x.
- Deschasaux M, Souberbielle JC, Latino-Martel P, Sutton A, Charnaux N, Druesne-Pecollo N, Galan P, Hercberg S, Le Clerc S, Kesse-Guyot E, Ezzedine K, Touvier M. Prospective associations between vitamin D status, vitamin D-related gene polymorphisms, and risk of tobacco-related cancers. Am J Clin Nutr. 2015 Nov;102(5):1207-15. doi: 10.3945/ajcn.115.110510. Epub 2015 Oct 7.
- Kesse-Guyot E, Lassale C, Assmann KE, Andreeva VA, Julia C, Blacher J, Fezeu L, Hercberg S, Galan P. Are different vascular risk scores calculated at midlife uniformly associated with subsequent poor cognitive performance? Atherosclerosis. 2015 Nov;243(1):286-92. doi: 10.1016/j.atherosclerosis.2015.09.023. Epub 2015 Sep 21.
- Donnenfeld M, Deschasaux M, Latino-Martel P, Diallo A, Galan P, Hercberg S, Ezzedine K, Touvier M. Prospective association between dietary folate intake and skin cancer risk: results from the Supplementation en Vitamines et Mineraux Antioxydants cohort. Am J Clin Nutr. 2015 Aug;102(2):471-8. doi: 10.3945/ajcn.115.109041. Epub 2015 Jul 8.
- Chhim AS, Fassier P, Latino-Martel P, Druesne-Pecollo N, Zelek L, Duverger L, Hercberg S, Galan P, Deschasaux M, Touvier M. Prospective association between alcohol intake and hormone-dependent cancer risk: modulation by dietary fiber intake. Am J Clin Nutr. 2015 Jul;102(1):182-9. doi: 10.3945/ajcn.114.098418. Epub 2015 May 20.
- Kesse-Guyot E, Andreeva VA, Touvier M, Jeandel C, Ferry M, Hercberg S, Galan P; SU.VI.MAX 2 Research Group. Overall and abdominal adiposity in midlife and subsequent cognitive function. J Nutr Health Aging. 2015 Feb;19(2):183-9. doi: 10.1007/s12603-014-0508-2.
- Deschasaux M, Pouchieu C, His M, Hercberg S, Latino-Martel P, Touvier M. Dietary total and insoluble fiber intakes are inversely associated with prostate cancer risk. J Nutr. 2014 Apr;144(4):504-10. doi: 10.3945/jn.113.189670. Epub 2014 Feb 19.
- Touvier M, Deschasaux M, Montourcy M, Sutton A, Charnaux N, Kesse-Guyot E, Fezeu LK, Latino-Martel P, Druesne-Pecollo N, Malvy D, Galan P, Hercberg S, Ezzedine K, Souberbielle JC. Interpretation of plasma PTH concentrations according to 25OHD status, gender, age, weight status, and calcium intake: importance of the reference values. J Clin Endocrinol Metab. 2014 Apr;99(4):1196-203. doi: 10.1210/jc.2013-3349. Epub 2014 Feb 14.
- Andreeva VA, Galan P, Arnaud J, Julia C, Hercberg S, Kesse-Guyot E. Midlife iron status is inversely associated with subsequent cognitive performance, particularly in perimenopausal women. J Nutr. 2013 Dec;143(12):1974-81. doi: 10.3945/jn.113.177089. Epub 2013 Oct 2.
- Julia C, Touvier M, Meunier N, Papet I, Galan P, Hercberg S, Kesse-Guyot E. Intakes of PUFAs were inversely associated with plasma C-reactive protein 12 years later in a middle-aged population with vitamin E intake as an effect modifier. J Nutr. 2013 Nov;143(11):1760-6. doi: 10.3945/jn.113.180943. Epub 2013 Sep 11.
- Kesse-Guyot E, Andreeva VA, Jeandel C, Ferry M, Touvier M, Hercberg S, Galan P. Alcohol consumption in midlife and cognitive performance assessed 13 years later in the SU.VI.MAX 2 cohort. PLoS One. 2012;7(12):e52311. doi: 10.1371/journal.pone.0052311. Epub 2012 Dec 19.
- Kesse-Guyot E, Andreeva VA, Lassale C, Ferry M, Jeandel C, Hercberg S, Galan P; SU.VI.MAX 2 Research Group. Mediterranean diet and cognitive function: a French study. Am J Clin Nutr. 2013 Feb;97(2):369-76. doi: 10.3945/ajcn.112.047993. Epub 2013 Jan 2.
- Kesse-Guyot E, Charreire H, Andreeva VA, Touvier M, Hercberg S, Galan P, Oppert JM. Cross-sectional and longitudinal associations of different sedentary behaviors with cognitive performance in older adults. PLoS One. 2012;7(10):e47831. doi: 10.1371/journal.pone.0047831. Epub 2012 Oct 17.
- Kesse-Guyot E, Ahluwalia N, Lassale C, Hercberg S, Fezeu L, Lairon D. Adherence to Mediterranean diet reduces the risk of metabolic syndrome: a 6-year prospective study. Nutr Metab Cardiovasc Dis. 2013 Jul;23(7):677-83. doi: 10.1016/j.numecd.2012.02.005. Epub 2012 May 25.
- Touvier M, Kesse-Guyot E, Andreeva VA, Fezeu L, Charnaux N, Sutton A, Druesne-Pecollo N, Hercberg S, Galan P, Zelek L, Latino-Martel P, Czernichow S. Modulation of the association between plasma intercellular adhesion molecule-1 and cancer risk by n-3 PUFA intake: a nested case-control study. Am J Clin Nutr. 2012 Apr;95(4):944-50. doi: 10.3945/ajcn.111.027805. Epub 2012 Feb 29.
- Briancon S, Boini S, Bertrais S, Guillemin F, Galan P, Hercberg S. Long-term antioxidant supplementation has no effect on health-related quality of life: the randomized, double-blind, placebo-controlled, primary prevention SU.VI.MAX trial. Int J Epidemiol. 2011 Dec;40(6):1605-16. doi: 10.1093/ije/dyr161.
- Peneau S, Galan P, Jeandel C, Ferry M, Andreeva V, Hercberg S, Kesse-Guyot E; SU.VI.MAX 2 Research Group. Fruit and vegetable intake and cognitive function in the SU.VI.MAX 2 prospective study. Am J Clin Nutr. 2011 Nov;94(5):1295-303. doi: 10.3945/ajcn.111.014712. Epub 2011 Sep 28.
- Kesse-Guyot E, Fezeu L, Jeandel C, Ferry M, Andreeva V, Amieva H, Hercberg S, Galan P. French adults' cognitive performance after daily supplementation with antioxidant vitamins and minerals at nutritional doses: a post hoc analysis of the Supplementation in Vitamins and Mineral Antioxidants (SU.VI.MAX) trial. Am J Clin Nutr. 2011 Sep;94(3):892-9. doi: 10.3945/ajcn.110.007815. Epub 2011 Jul 20.
- Perez-Jimenez J, Fezeu L, Touvier M, Arnault N, Manach C, Hercberg S, Galan P, Scalbert A. Dietary intake of 337 polyphenols in French adults. Am J Clin Nutr. 2011 Jun;93(6):1220-8. doi: 10.3945/ajcn.110.007096. Epub 2011 Apr 13.
- Kesse-Guyot E, Amieva H, Castetbon K, Henegar A, Ferry M, Jeandel C, Hercberg S, Galan P; SU.VI.MAX 2 Research Group. Adherence to nutritional recommendations and subsequent cognitive performance: findings from the prospective Supplementation with Antioxidant Vitamins and Minerals 2 (SU.VI.MAX 2) study. Am J Clin Nutr. 2011 Jan;93(1):200-10. doi: 10.3945/ajcn.2010.29761. Epub 2010 Nov 24.
- Ezzedine K, Latreille J, Kesse-Guyot E, Galan P, Hercberg S, Guinot C, Malvy D. Incidence of skin cancers during 5-year follow-up after stopping antioxidant vitamins and mineral supplementation. Eur J Cancer. 2010 Dec;46(18):3316-22. doi: 10.1016/j.ejca.2010.06.008. Epub 2010 Jul 6.
- Kesse-Guyot E, Vergnaud AC, Fezeu L, Zureik M, Blacher J, Peneau S, Hercberg S, Galan P, Czernichow S. Associations between dietary patterns and arterial stiffness, carotid artery intima-media thickness and atherosclerosis. Eur J Cardiovasc Prev Rehabil. 2010 Dec;17(6):718-24. doi: 10.1097/HJR.0b013e32833a197f.
- Phillips CM, Goumidi L, Bertrais S, Field MR, Cupples LA, Ordovas JM, Defoort C, Lovegrove JA, Drevon CA, Gibney MJ, Blaak EE, Kiec-Wilk B, Karlstrom B, Lopez-Miranda J, McManus R, Hercberg S, Lairon D, Planells R, Roche HM. Gene-nutrient interactions with dietary fat modulate the association between genetic variation of the ACSL1 gene and metabolic syndrome. J Lipid Res. 2010 Jul;51(7):1793-800. doi: 10.1194/jlr.M003046. Epub 2010 Feb 22.
- Phillips CM, Goumidi L, Bertrais S, Ferguson JF, Field MR, Kelly ED, Peloso GM, Cupples LA, Shen J, Ordovas JM, McManus R, Hercberg S, Portugal H, Lairon D, Planells R, Roche HM. Complement component 3 polymorphisms interact with polyunsaturated fatty acids to modulate risk of metabolic syndrome. Am J Clin Nutr. 2009 Dec;90(6):1665-73. doi: 10.3945/ajcn.2009.28101. Epub 2009 Oct 14.
- Czernichow S, Vergnaud AC, Galan P, Arnaud J, Favier A, Faure H, Huxley R, Hercberg S, Ahluwalia N. Effects of long-term antioxidant supplementation and association of serum antioxidant concentrations with risk of metabolic syndrome in adults. Am J Clin Nutr. 2009 Aug;90(2):329-35. doi: 10.3945/ajcn.2009.27635. Epub 2009 Jun 2.
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
1994年10月1日
研究完成 (实际的)
2005年9月1日
研究注册日期
首次提交
2006年1月3日
首先提交符合 QC 标准的
2006年1月4日
首次发布 (估计)
2006年1月6日
研究记录更新
最后更新发布 (估计)
2009年12月17日
上次提交的符合 QC 标准的更新
2009年12月16日
最后验证
2007年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.