抗酸化ビタミンとミネラルの健康効果の一次予防試験。
SU.VI.MAX研究。抗酸化ビタミンとミネラルの健康への影響に関する無作為化プラセボ対照予防試験。
調査の概要
詳細な説明
実験的研究から、フリーラジカルが多くの病理学的プロセスを誘発する可能性があることが知られており、その抗酸化能力のために、ベータカロチン、ビタミン C、ビタミン E、セレン、亜鉛などの栄養素がそのような有害な影響を防ぐ可能性があることが示唆されています. 横断研究、症例対照研究、および前向き研究からの疫学的データは、抗酸化ビタミンやミネラル、またはこれらの栄養素が豊富な食品の摂取と、がんや虚血性心血管疾患 (CVD) のリスクとの間に強い関係があることを実際に示しています。 しかし、抗酸化微量栄養素を単独またはペアで長期間にわたって高用量で投与したランダム化プラセボ対照一次予防試験では、この潜在的な有益な効果を証明できず、そのうちの2つは有害な影響さえ示唆していました. 観察研究とこれらの無作為化試験との間の一見矛盾する結果は、臨床試験で使用された用量が、観察研究で最低レベルと関連していることがわかっている通常の食事摂取によって到達可能な最高レベルよりもはるかに高かったという事実によって説明できます。がんやCVDのリスク。 実際、総死亡率とがんの発生率に対する有益な効果を観察した唯一の試験は、いくつかのビタミンとミネラルの組み合わせの栄養用量を使用し、この地域の生活条件が悪いため、ベースライン微量栄養素の状態が非常に低い中国人に対して実施されました. (9)。
「Supplementation en VItamines et Minéraux AntioXydants」(SU.VI.MAX)研究の目的は、抗酸化栄養素の十分かつバランスの取れた摂取が癌および虚血の発生率を低下させるかどうかを無作為化プラセボ対照試験でテストすることでした。中年の一般集団における心血管疾患。
研究の種類
入学
段階
- フェーズ 3
連絡先と場所
研究場所
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Paris、フランス、75003
- U557 Inserm
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
包含基準:
- 女性は35~60歳、男性は45~60歳
- プラセボを投与される可能性を受け入れ、参加の制約を受け入れる
- 提供されたサプリメント中のビタミンまたはミネラルのいずれかによる以前の定期的な補給の欠如
- 食事に関する極端な信念や行動がないこと
除外基準:
- 積極的な参加を妨げたり、5年生存を脅かしたりする可能性が高い疾患
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
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主要な致命的および非致命的な虚血性心血管イベント
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基底細胞皮膚癌を除くあらゆる種類の癌
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二次結果の測定
結果測定 |
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健康関連の生活の質
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すべての原因の死亡率
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臨床状態の中間基準
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生物学的状態の中間基準
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人体測定ステータスの中間基準
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協力者と研究者
捜査官
- 主任研究者:Serge Hercberg, MD, PhD、U557 Inserm (UMR Inserm/Inra/CNAM), Institut Scientifique et Technique de la Nutrition et de l'Alimentation/CNAM
出版物と役立つリンク
一般刊行物
- 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.
便利なリンク
研究記録日
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研究開始
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
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