进餐时间和血压
2023年3月21日 更新者：University of Wisconsin, Madison
进餐时间对成人神经血管控制的影响
将在短暂的干预期前后测量中年人的脑血流量、血压和神经血管控制机制。
干预将包括改变参与者每天进食的时间。
研究概览
详细说明
与白天血压相比，健康成年人的夜间血压降低 10-20%。 然而，20-40% 的中年人并没有表现出血压下降。 异常的血压模式与睡眠障碍、高血压有关，并与心血管风险和死亡率升高有关。 此外，异常的昼夜血压模式与循环的神经血管控制受损有关，导致高血压、中风和心血管疾病的风险增加。 重要的是，中年是实施干预措施以预防或延缓未来心血管疾病的关键时期。 最近的数据表明，限时喂养可以使血压模式正常化。 本研究的总体目标是确定限时喂养是否能使血压模式正常化并改善神经血管控制。
研究目标是：
- 确定进餐时间对中年成年人血压模式的影响。
- 确定进餐时间对中年成年人神经血管控制的影响。
研究类型
介入性
注册 (实际的)
34
阶段
- 不适用
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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Wisconsin
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Madison、Wisconsin、美国、53706
- University of Wisconsin-Madison
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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
50年 至 65年 (成人、年长者)
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：
- 体重指数 ≤ 34 公斤/平方米
- 禁止吸烟
- 久坐或娱乐活动
- 每天≤ 2 杯酒精饮品
- 女性受试者：围绝经期/绝经后
排除标准：
- 肝、肾、血液、外周血管疾病或中风/神经血管疾病、糖尿病、未控制的高血压、睡眠呼吸暂停的病史或证据
- 关于用于治疗/控制上述疾病的药物
- 通宵工作
- 临床诊断的焦虑或抑郁
- 怀孕或试图怀孕
- 重要的手术史
- 研究者酌情决定的其他重要医疗状况
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：基础科学
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：限时喂食
控制（基线）：将测量血压和神经血管控制。 干预后：将测量血压和神经血管控制。 |
基线测量完成后，参与者将参加限时喂养干预。
参与者将被要求将他们每天进食的时间限制在 10 小时以内，其余 14 小时禁食。
还将要求参与者至少在睡前 2 小时吃完当天的最后一餐。
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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在 24 小时内连续测量血压
大体时间：在 24 小时内连续
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使用动态血压监测仪在 24 小时内连续测量血压值。
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在 24 小时内连续
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神经血管控制：脑血流的变化
大体时间：基线和 5 周
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大脑血流的变化将使用经颅多普勒超声测量以响应呼吸测试。
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基线和 5 周
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神经血管控制：血压变化
大体时间：基线和 5 周
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呼吸测试引起的血压变化。
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基线和 5 周
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神经血管控制：交感神经活动的变化
大体时间：基线和 5 周
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交感神经活动的变化将使用显微神经造影术响应呼吸测试来测量。
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基线和 5 周
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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。
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
- Varady KA, Bhutani S, Klempel MC, Kroeger CM, Trepanowski JF, Haus JM, Hoddy KK, Calvo Y. Alternate day fasting for weight loss in normal weight and overweight subjects: a randomized controlled trial. Nutr J. 2013 Nov 12;12(1):146. doi: 10.1186/1475-2891-12-146.
- Sutton EF, Beyl R, Early KS, Cefalu WT, Ravussin E, Peterson CM. Early Time-Restricted Feeding Improves Insulin Sensitivity, Blood Pressure, and Oxidative Stress Even without Weight Loss in Men with Prediabetes. Cell Metab. 2018 Jun 5;27(6):1212-1221.e3. doi: 10.1016/j.cmet.2018.04.010. Epub 2018 May 10.
- Barnosky AR, Hoddy KK, Unterman TG, Varady KA. Intermittent fasting vs daily calorie restriction for type 2 diabetes prevention: a review of human findings. Transl Res. 2014 Oct;164(4):302-11. doi: 10.1016/j.trsl.2014.05.013. Epub 2014 Jun 12.
- Barnes JN. Exercise, cognitive function, and aging. Adv Physiol Educ. 2015 Jun;39(2):55-62. doi: 10.1152/advan.00101.2014.
- Rickards CA, Johnson BD, Harvey RE, Convertino VA, Joyner MJ, Barnes JN. Cerebral blood velocity regulation during progressive blood loss compared with lower body negative pressure in humans. J Appl Physiol (1985). 2015 Sep 15;119(6):677-85. doi: 10.1152/japplphysiol.00127.2015. Epub 2015 Jul 2.
- Verdecchia P, Porcellati C, Schillaci G, Borgioni C, Ciucci A, Battistelli M, Guerrieri M, Gatteschi C, Zampi I, Santucci A, Santucci C, Reboldi G, et al. Ambulatory blood pressure. An independent predictor of prognosis in essential hypertension. Hypertension. 1994 Dec;24(6):793-801. doi: 10.1161/01.hyp.24.6.793. Erratum In: Hypertension 1995 Mar;25(3):462.
- Fagard RH, Celis H, Thijs L, Staessen JA, Clement DL, De Buyzere ML, De Bacquer DA. Daytime and nighttime blood pressure as predictors of death and cause-specific cardiovascular events in hypertension. Hypertension. 2008 Jan;51(1):55-61. doi: 10.1161/HYPERTENSIONAHA.107.100727. Epub 2007 Nov 26.
- Oosterman JE, Kalsbeek A, la Fleur SE, Belsham DD. Impact of nutrients on circadian rhythmicity. Am J Physiol Regul Integr Comp Physiol. 2015 Mar 1;308(5):R337-50. doi: 10.1152/ajpregu.00322.2014. Epub 2014 Dec 17.
- Patterson RE, Laughlin GA, LaCroix AZ, Hartman SJ, Natarajan L, Senger CM, Martinez ME, Villasenor A, Sears DD, Marinac CR, Gallo LC. Intermittent Fasting and Human Metabolic Health. J Acad Nutr Diet. 2015 Aug;115(8):1203-12. doi: 10.1016/j.jand.2015.02.018. Epub 2015 Apr 6. No abstract available.
- Klempel MC, Kroeger CM, Varady KA. Alternate day fasting (ADF) with a high-fat diet produces similar weight loss and cardio-protection as ADF with a low-fat diet. Metabolism. 2013 Jan;62(1):137-43. doi: 10.1016/j.metabol.2012.07.002. Epub 2012 Aug 11.
- Panda S. Circadian physiology of metabolism. Science. 2016 Nov 25;354(6315):1008-1015. doi: 10.1126/science.aah4967.
- Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2018 May 15;71(19):e127-e248. doi: 10.1016/j.jacc.2017.11.006. Epub 2017 Nov 13. No abstract available. Erratum In: J Am Coll Cardiol. 2018 May 15;71(19):2275-2279.
- Wei M, Brandhorst S, Shelehchi M, Mirzaei H, Cheng CW, Budniak J, Groshen S, Mack WJ, Guen E, Di Biase S, Cohen P, Morgan TE, Dorff T, Hong K, Michalsen A, Laviano A, Longo VD. Fasting-mimicking diet and markers/risk factors for aging, diabetes, cancer, and cardiovascular disease. Sci Transl Med. 2017 Feb 15;9(377):eaai8700. doi: 10.1126/scitranslmed.aai8700.
- Longo VD, Panda S. Fasting, Circadian Rhythms, and Time-Restricted Feeding in Healthy Lifespan. Cell Metab. 2016 Jun 14;23(6):1048-1059. doi: 10.1016/j.cmet.2016.06.001.
- Hatori M, Vollmers C, Zarrinpar A, DiTacchio L, Bushong EA, Gill S, Leblanc M, Chaix A, Joens M, Fitzpatrick JA, Ellisman MH, Panda S. Time-restricted feeding without reducing caloric intake prevents metabolic diseases in mice fed a high-fat diet. Cell Metab. 2012 Jun 6;15(6):848-60. doi: 10.1016/j.cmet.2012.04.019. Epub 2012 May 17.
- Pearson TA, Blair SN, Daniels SR, Eckel RH, Fair JM, Fortmann SP, Franklin BA, Goldstein LB, Greenland P, Grundy SM, Hong Y, Miller NH, Lauer RM, Ockene IS, Sacco RL, Sallis JF Jr, Smith SC Jr, Stone NJ, Taubert KA. AHA Guidelines for Primary Prevention of Cardiovascular Disease and Stroke: 2002 Update: Consensus Panel Guide to Comprehensive Risk Reduction for Adult Patients Without Coronary or Other Atherosclerotic Vascular Diseases. American Heart Association Science Advisory and Coordinating Committee. Circulation. 2002 Jul 16;106(3):388-91. doi: 10.1161/01.cir.0000020190.45892.75. No abstract available.
- Ingelsson E, Bjorklund-Bodegard K, Lind L, Arnlov J, Sundstrom J. Diurnal blood pressure pattern and risk of congestive heart failure. JAMA. 2006 Jun 28;295(24):2859-66. doi: 10.1001/jama.295.24.2859.
- de la Sierra A, Redon J, Banegas JR, Segura J, Parati G, Gorostidi M, de la Cruz JJ, Sobrino J, Llisterri JL, Alonso J, Vinyoles E, Pallares V, Sarria A, Aranda P, Ruilope LM; Spanish Society of Hypertension Ambulatory Blood Pressure Monitoring Registry Investigators. Prevalence and factors associated with circadian blood pressure patterns in hypertensive patients. Hypertension. 2009 Mar;53(3):466-72. doi: 10.1161/HYPERTENSIONAHA.108.124008. Epub 2009 Jan 26.
- Loredo JS, Nelesen R, Ancoli-Israel S, Dimsdale JE. Sleep quality and blood pressure dipping in normal adults. Sleep. 2004 Sep 15;27(6):1097-103. doi: 10.1093/sleep/27.6.1097.
- Verdecchia P, Schillaci G, Gatteschi C, Zampi I, Battistelli M, Bartoccini C, Porcellati C. Blunted nocturnal fall in blood pressure in hypertensive women with future cardiovascular morbid events. Circulation. 1993 Sep;88(3):986-92. doi: 10.1161/01.cir.88.3.986.
- Hajjar I, Selim M, Novak P, Novak V. The relationship between nighttime dipping in blood pressure and cerebral hemodynamics in nonstroke patients. J Clin Hypertens (Greenwich). 2007 Dec;9(12):929-36. doi: 10.1111/j.1524-6175.2007.07342.x.
- Grassi G, Seravalle G, Quarti-Trevano F, Dell'Oro R, Bombelli M, Cuspidi C, Facchetti R, Bolla G, Mancia G. Adrenergic, metabolic, and reflex abnormalities in reverse and extreme dipper hypertensives. Hypertension. 2008 Nov;52(5):925-31. doi: 10.1161/HYPERTENSIONAHA.108.116368. Epub 2008 Sep 8.
- Douma LG, Gumz ML. Circadian clock-mediated regulation of blood pressure. Free Radic Biol Med. 2018 May 1;119:108-114. doi: 10.1016/j.freeradbiomed.2017.11.024. Epub 2017 Dec 2.
- Su WL, J. Guo, Z., and Gong, M.C. Time of Food Intake is an Important Determinant of Blood Pressure Circadian Rhythm. Hypertension. 2015;66:AP:225.
- Nikolaeva S, Pradervand S, Centeno G, Zavadova V, Tokonami N, Maillard M, Bonny O, Firsov D. The circadian clock modulates renal sodium handling. J Am Soc Nephrol. 2012 Jun;23(6):1019-26. doi: 10.1681/ASN.2011080842. Epub 2012 Mar 22.
- Grassi G, Bombelli M, Seravalle G, Dell'Oro R, Quarti-Trevano F. Diurnal blood pressure variation and sympathetic activity. Hypertens Res. 2010 May;33(5):381-5. doi: 10.1038/hr.2010.26. Epub 2010 Mar 5.
- Fryar CD, Chen TC, Li X. Prevalence of uncontrolled risk factors for cardiovascular disease: United States, 1999-2010. NCHS Data Brief. 2012 Aug;(103):1-8.
- Prevention CfDCa. Vital Signs. 2018.
- Palsson R, Patel UD. Cardiovascular complications of diabetic kidney disease. Adv Chronic Kidney Dis. 2014 May;21(3):273-80. doi: 10.1053/j.ackd.2014.03.003.
- Chamberlain JJ, Johnson EL, Leal S, Rhinehart AS, Shubrook JH, Peterson L. Cardiovascular Disease and Risk Management: Review of the American Diabetes Association Standards of Medical Care in Diabetes 2018. Ann Intern Med. 2018 May 1;168(9):640-650. doi: 10.7326/M18-0222. Epub 2018 Apr 3.
- Luchsinger JA. Type 2 diabetes, related conditions, in relation and dementia: an opportunity for prevention? J Alzheimers Dis. 2010;20(3):723-36. doi: 10.3233/JAD-2010-091687.
- Boggia J, Li Y, Thijs L, Hansen TW, Kikuya M, Bjorklund-Bodegard K, Richart T, Ohkubo T, Kuznetsova T, Torp-Pedersen C, Lind L, Ibsen H, Imai Y, Wang J, Sandoya E, O'Brien E, Staessen JA; International Database on Ambulatory blood pressure monitoring in relation to Cardiovascular Outcomes (IDACO) investigators. Prognostic accuracy of day versus night ambulatory blood pressure: a cohort study. Lancet. 2007 Oct 6;370(9594):1219-29. doi: 10.1016/S0140-6736(07)61538-4.
- Fagard RH, Thijs L, Staessen JA, Clement DL, De Buyzere ML, De Bacquer DA. Night-day blood pressure ratio and dipping pattern as predictors of death and cardiovascular events in hypertension. J Hum Hypertens. 2009 Oct;23(10):645-53. doi: 10.1038/jhh.2009.9. Epub 2009 Feb 19.
- Fagard RH, Thijs L, Staessen JA, Clement DL, De Buyzere ML, De Bacquer DA. Prognostic significance of ambulatory blood pressure in hypertensive patients with history of cardiovascular disease. Blood Press Monit. 2008 Dec;13(6):325-32. doi: 10.1097/MBP.0b013e32831054f5.
- Mancia G, Bombelli M, Facchetti R, Madotto F, Corrao G, Trevano FQ, Grassi G, Sega R. Long-term prognostic value of blood pressure variability in the general population: results of the Pressioni Arteriose Monitorate e Loro Associazioni Study. Hypertension. 2007 Jun;49(6):1265-70. doi: 10.1161/HYPERTENSIONAHA.107.088708. Epub 2007 Apr 23.
- De Nicola L, Conte G, Minutolo R. Prediabetes as a Precursor to Diabetic Kidney Disease. Am J Kidney Dis. 2016 Jun;67(6):817-9. doi: 10.1053/j.ajkd.2016.03.411. No abstract available.
- Sorensen BM, Houben AJ, Berendschot TT, Schouten JS, Kroon AA, van der Kallen CJ, Henry RM, Koster A, Sep SJ, Dagnelie PC, Schaper NC, Schram MT, Stehouwer CD. Prediabetes and Type 2 Diabetes Are Associated With Generalized Microvascular Dysfunction: The Maastricht Study. Circulation. 2016 Nov 1;134(18):1339-1352. doi: 10.1161/CIRCULATIONAHA.116.023446. Epub 2016 Sep 27.
- Brotman DJ, Davidson MB, Boumitri M, Vidt DG. Impaired diurnal blood pressure variation and all-cause mortality. Am J Hypertens. 2008 Jan;21(1):92-7. doi: 10.1038/ajh.2007.7.
- Ohkubo T, Imai Y, Tsuji I, Nagai K, Watanabe N, Minami N, Kato J, Kikuchi N, Nishiyama A, Aihara A, Sekino M, Satoh H, Hisamichi S. Relation between nocturnal decline in blood pressure and mortality. The Ohasama Study. Am J Hypertens. 1997 Nov;10(11):1201-7. doi: 10.1016/s0895-7061(97)00274-4.
- Viera AJ, Shimbo D. Ambulatory blood pressure phenotypes and the risk for hypertension. Curr Hypertens Rep. 2014 Oct;16(10):481. doi: 10.1007/s11906-014-0481-5.
- Su W, Guo Z, Randall DC, Cassis L, Brown DR, Gong MC. Hypertension and disrupted blood pressure circadian rhythm in type 2 diabetic db/db mice. Am J Physiol Heart Circ Physiol. 2008 Oct;295(4):H1634-41. doi: 10.1152/ajpheart.00257.2008. Epub 2008 Aug 15.
- Su W, Xie Z, Guo Z, Duncan MJ, Lutshumba J, Gong MC. Altered clock gene expression and vascular smooth muscle diurnal contractile variations in type 2 diabetic db/db mice. Am J Physiol Heart Circ Physiol. 2012 Feb 1;302(3):H621-33. doi: 10.1152/ajpheart.00825.2011. Epub 2011 Dec 2.
- Barr EL, Zimmet PZ, Welborn TA, Jolley D, Magliano DJ, Dunstan DW, Cameron AJ, Dwyer T, Taylor HR, Tonkin AM, Wong TY, McNeil J, Shaw JE. Risk of cardiovascular and all-cause mortality in individuals with diabetes mellitus, impaired fasting glucose, and impaired glucose tolerance: the Australian Diabetes, Obesity, and Lifestyle Study (AusDiab). Circulation. 2007 Jul 10;116(2):151-7. doi: 10.1161/CIRCULATIONAHA.106.685628. Epub 2007 Jun 18.
- Gupta AK, Greenway FL, Cornelissen G, Pan W, Halberg F. Prediabetes is associated with abnormal circadian blood pressure variability. J Hum Hypertens. 2008 Sep;22(9):627-33. doi: 10.1038/jhh.2008.32. Epub 2008 May 15.
- Chaix A, Zarrinpar A, Miu P, Panda S. Time-restricted feeding is a preventative and therapeutic intervention against diverse nutritional challenges. Cell Metab. 2014 Dec 2;20(6):991-1005. doi: 10.1016/j.cmet.2014.11.001.
- Rothschild J, Hoddy KK, Jambazian P, Varady KA. Time-restricted feeding and risk of metabolic disease: a review of human and animal studies. Nutr Rev. 2014 May;72(5):308-18. doi: 10.1111/nure.12104. Epub 2014 Apr 16.
- Gill S, Le HD, Melkani GC, Panda S. Time-restricted feeding attenuates age-related cardiac decline in Drosophila. Science. 2015 Mar 13;347(6227):1265-9. doi: 10.1126/science.1256682.
- Mager DE, Wan R, Brown M, Cheng A, Wareski P, Abernethy DR, Mattson MP. Caloric restriction and intermittent fasting alter spectral measures of heart rate and blood pressure variability in rats. FASEB J. 2006 Apr;20(6):631-7. doi: 10.1096/fj.05-5263com.
- Trepanowski JF, Kroeger CM, Barnosky A, Klempel M, Bhutani S, Hoddy KK, Rood J, Ravussin E, Varady KA. Effects of alternate-day fasting or daily calorie restriction on body composition, fat distribution, and circulating adipokines: Secondary analysis of a randomized controlled trial. Clin Nutr. 2018 Dec;37(6 Pt A):1871-1878. doi: 10.1016/j.clnu.2017.11.018. Epub 2017 Dec 5.
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 (实际的)
2022年2月2日
初级完成 (实际的)
2022年12月16日
研究完成 (实际的)
2022年12月16日
研究注册日期
首次提交
2019年10月16日
首先提交符合 QC 标准的
2019年10月17日
首次发布 (实际的)
2019年10月21日
研究记录更新
最后更新发布 (实际的)
2023年3月22日
上次提交的符合 QC 标准的更新
2023年3月21日
最后验证
2023年3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.