严重能量不足和恢复期间睾酮的生理和心理影响 (OPS)
2019年1月3日 更新者:Jennifer C. Rood、Pennington Biomedical Research Center
严重能量不足和恢复期间睾酮的生理和心理影响:一项随机、安慰剂对照试验
本研究的目的是确定在严重、持续的能量不足期间维持性腺正常状态是否会减轻生理衰退,尤其是瘦体重的减少。
研究概览
详细说明
这项研究将招募多达 60 名身体活跃的男性参加一项 3 阶段随机、安慰剂对照试验。
在完成 14 天(自由生活,第一阶段)、能量充足的饮食适应阶段后(蛋白质,1.6 g∙kg-1∙d-1;脂肪占总能量摄入的 30%,剩余能量来自碳水化合物),参与者将被随机分配到两个实验组之一,并接受为期 28 天(留宿,第 2 阶段)、55% 能量不足阶段:仅能量不足 (DEF) 或能量不足 + 外源性睾酮 (DEF+TEST) .
恢复(自由生活,第 3 阶段)将在完成第 2 阶段后进行评估,以确定体重何时恢复到初始体重的 ± 2.5% 以内(持续时间会有所不同,第 3 阶段最长为 42 天)。
这项研究将描述战士在军事训练和作战行动中遇到的生理和心理状态的复杂标记的生理和心理需求导致睾丸激素下降的贡献,解决直接的、持续观察到的知识差距。
研究类型
介入性
注册 (实际的)
53
阶段
- 第四阶段
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
-
-
Louisiana
-
Baton Rouge、Louisiana、美国、70808
- Pennington Biomedical Research Center
-
-
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
18年 至 39年 (成人)
接受健康志愿者
是的
有资格学习的性别
男性
描述
纳入标准:
- 身体活跃(每周至少 2 天有氧运动和/或阻力运动)
- 除非研究医师提供/批准,否则在整个研究期间之前和期间不服用任何处方药和/或愿意避免使用所有药物
愿意在整个研究期间避免饮酒、吸烟、电子烟或使用任何尼古丁产品、咖啡因和膳食补充剂
- 由研究医师决定,药物、补充剂和非处方药的洗脱期≥ 1 至 4 周
- 咖啡因和酒精的清除期≥7天
- 愿意连续 28 天住在彭宁顿生物医学研究中心住院部
- 愿意进行尿液药物筛查
- 符合根据陆军条例 600-9 规定的特定年龄的美国陆军身体成分标准,其中包括基于身高、体重和围度测量(颈部和腰部)的身体脂肪百分比估计值
- 总睾酮浓度在正常生理范围内,总睾酮 (300-1,000 ng/dL)。
排除标准:
- 影响运动能力的肌肉骨骼损伤
- 已确诊的心脏代谢疾病(即高血压、高血脂、肾病、糖尿病等)
- 对食物过敏或不耐受、素食或利多卡因并发症史
- 在过去 6 个月内使用合成代谢类固醇、人类生长激素或营养性睾酮前体样补充剂
- 在研究期间不会戒烟(任何尼古丁产品)、酒精、咖啡因或任何其他膳食补充剂
- 在参与研究后 3 个月内使用过任何抗生素,局部抗生素除外
- 参与研究后 3 个月内进行结肠镜检查
- 长期使用泻药、大便软化剂、抗酸剂或止泻药(≥每周一次)
- 胃肠道疾病史(例如,腹腔疾病、肠易激综合征、结肠炎、克罗恩病)
- 由研究的心理和行为评估人员评估的节食者(三因素饮食问卷)
- 成年人无法同意
- 女性
- 犯人
- 金属植入物、幽闭恐惧症、头部尺寸与 MRI 设备不相容等。
- 久坐不动或每周进行 <2 天的体育锻炼(有氧和/或阻力训练)
- 根据陆军条例 600-9,超过特定年龄的美国陆军身体成分标准
- 除非医学调查员另有批准,否则既往有肾结石病史
- 收缩压 > 150 或舒张压 > 95 mmHg
- 既往有乳腺癌或前列腺癌病史
- 既往有慢性阻塞性肺病或阻塞性睡眠呼吸暂停病史
- 前列腺特异性抗原 > 3ng/ml、血细胞比容 > 50% 或阳性尿液药物筛查的实验室结果的发现
- 根据研究小组的临床判断,受试者可能不适合参与研究
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:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
安慰剂比较:能源赤字
随机分配到对照条件的参与者将受到运动引起的能量消耗,导致 55% 的能量不足,并将在试验的第 2 阶段接受芝麻油安慰剂注射。
|
在第 15、21、28 和 35 天每周肌肉注射 200 毫克芝麻油
|
实验性的:能量不足 + 睾酮
随机分配到干预条件的参与者将受到运动引起的能量消耗,导致 55% 的能量不足,并将在试验的第 2 阶段接受庚酸睾酮注射。
|
在第 15、21、28 和 35 天每周肌肉注射 200 毫克庚酸睾酮
|
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 |
---|---|---|
每个研究阶段结束时的身体成分
大体时间:每个研究阶段结束:第 1 阶段第 11 天,第 2 阶段第 39 天,第 3 阶段第 85 天
|
使用测距仪测量高度。
使用校准的数字秤测量重量。
使用双能 X 射线吸收测定法确定身体成分。
这些数据用于计算去脂体重、脂肪质量和全身组织质量。
|
每个研究阶段结束:第 1 阶段第 11 天,第 2 阶段第 39 天,第 3 阶段第 85 天
|
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。
合作者
调查人员
- 首席研究员:Jennifer C Rood, Ph.D.、Pennington Biomedical Research Center
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
- Baron-Cohen S, Wheelwright S, Hill J, Raste Y, Plumb I. The "Reading the Mind in the Eyes" Test revised version: a study with normal adults, and adults with Asperger syndrome or high-functioning autism. J Child Psychol Psychiatry. 2001 Feb;42(2):241-51.
- Stunkard AJ, Messick S. The three-factor eating questionnaire to measure dietary restraint, disinhibition and hunger. J Psychosom Res. 1985;29(1):71-83. doi: 10.1016/0022-3999(85)90010-8.
- Blundell J, de Graaf C, Hulshof T, Jebb S, Livingstone B, Lluch A, Mela D, Salah S, Schuring E, van der Knaap H, Westerterp M. Appetite control: methodological aspects of the evaluation of foods. Obes Rev. 2010 Mar;11(3):251-70. doi: 10.1111/j.1467-789X.2010.00714.x. Epub 2010 Jan 29.
- Wycherley TP, Moran LJ, Clifton PM, Noakes M, Brinkworth GD. Effects of energy-restricted high-protein, low-fat compared with standard-protein, low-fat diets: a meta-analysis of randomized controlled trials. Am J Clin Nutr. 2012 Dec;96(6):1281-98. doi: 10.3945/ajcn.112.044321. Epub 2012 Oct 24.
- Morgenthaler T, Alessi C, Friedman L, Owens J, Kapur V, Boehlecke B, Brown T, Chesson A Jr, Coleman J, Lee-Chiong T, Pancer J, Swick TJ; Standards of Practice Committee; American Academy of Sleep Medicine. Practice parameters for the use of actigraphy in the assessment of sleep and sleep disorders: an update for 2007. Sleep. 2007 Apr;30(4):519-29. doi: 10.1093/sleep/30.4.519.
- Bray GA, Redman LM, de Jonge L, Covington J, Rood J, Brock C, Mancuso S, Martin CK, Smith SR. Effect of protein overfeeding on energy expenditure measured in a metabolic chamber. Am J Clin Nutr. 2015 Mar;101(3):496-505. doi: 10.3945/ajcn.114.091769. Epub 2015 Jan 14.
- Asarian L, Geary N. Sex differences in the physiology of eating. Am J Physiol Regul Integr Comp Physiol. 2013 Dec;305(11):R1215-67. doi: 10.1152/ajpregu.00446.2012. Epub 2013 Jul 31.
- van Winkel R, Stefanis NC, Myin-Germeys I. Psychosocial stress and psychosis. A review of the neurobiological mechanisms and the evidence for gene-stress interaction. Schizophr Bull. 2008 Nov;34(6):1095-105. doi: 10.1093/schbul/sbn101. Epub 2008 Aug 20.
- Caporaso JG, Kuczynski J, Stombaugh J, Bittinger K, Bushman FD, Costello EK, Fierer N, Pena AG, Goodrich JK, Gordon JI, Huttley GA, Kelley ST, Knights D, Koenig JE, Ley RE, Lozupone CA, McDonald D, Muegge BD, Pirrung M, Reeder J, Sevinsky JR, Turnbaugh PJ, Walters WA, Widmann J, Yatsunenko T, Zaneveld J, Knight R. QIIME allows analysis of high-throughput community sequencing data. Nat Methods. 2010 May;7(5):335-6. doi: 10.1038/nmeth.f.303. Epub 2010 Apr 11. No abstract available.
- Mifflin MD, St Jeor ST, Hill LA, Scott BJ, Daugherty SA, Koh YO. A new predictive equation for resting energy expenditure in healthy individuals. Am J Clin Nutr. 1990 Feb;51(2):241-7. doi: 10.1093/ajcn/51.2.241.
- Caporaso JG, Lauber CL, Walters WA, Berg-Lyons D, Huntley J, Fierer N, Owens SM, Betley J, Fraser L, Bauer M, Gormley N, Gilbert JA, Smith G, Knight R. Ultra-high-throughput microbial community analysis on the Illumina HiSeq and MiSeq platforms. ISME J. 2012 Aug;6(8):1621-4. doi: 10.1038/ismej.2012.8. Epub 2012 Mar 8.
- Beauchet O. Testosterone and cognitive function: current clinical evidence of a relationship. Eur J Endocrinol. 2006 Dec;155(6):773-81. doi: 10.1530/eje.1.02306.
- Roy TC. Diagnoses and mechanisms of musculoskeletal injuries in an infantry brigade combat team deployed to Afghanistan evaluated by the brigade physical therapist. Mil Med. 2011 Aug;176(8):903-8. doi: 10.7205/milmed-d-11-00006.
- Skakkebaek NE, Bancroft J, Davidson DW, Warner P. Androgen replacement with oral testosterone undecanoate in hypogonadal men: a double blind controlled study. Clin Endocrinol (Oxf). 1981 Jan;14(1):49-61. doi: 10.1111/j.1365-2265.1981.tb00364.x.
- WEIR JB. New methods for calculating metabolic rate with special reference to protein metabolism. J Physiol. 1949 Aug;109(1-2):1-9. doi: 10.1113/jphysiol.1949.sp004363. No abstract available.
- Mauras N, Hayes V, Welch S, Rini A, Helgeson K, Dokler M, Veldhuis JD, Urban RJ. Testosterone deficiency in young men: marked alterations in whole body protein kinetics, strength, and adiposity. J Clin Endocrinol Metab. 1998 Jun;83(6):1886-92. doi: 10.1210/jcem.83.6.4892.
- Kvorning T, Andersen M, Brixen K, Madsen K. Suppression of endogenous testosterone production attenuates the response to strength training: a randomized, placebo-controlled, and blinded intervention study. Am J Physiol Endocrinol Metab. 2006 Dec;291(6):E1325-32. doi: 10.1152/ajpendo.00143.2006. Epub 2006 Jul 25.
- Buss AH, Perry M. The aggression questionnaire. J Pers Soc Psychol. 1992 Sep;63(3):452-9. doi: 10.1037//0022-3514.63.3.452.
- Cummings DE. Ghrelin and the short- and long-term regulation of appetite and body weight. Physiol Behav. 2006 Aug 30;89(1):71-84. doi: 10.1016/j.physbeh.2006.05.022. Epub 2006 Jul 21.
- Weiner C. Anticipate and communicate: Ethical management of incidental and secondary findings in the clinical, research, and direct-to-consumer contexts (December 2013 report of the Presidential Commission for the Study of Bioethical Issues). Am J Epidemiol. 2014 Sep 15;180(6):562-4. doi: 10.1093/aje/kwu217. Epub 2014 Aug 22.
- Wang C, Swerdloff RS, Iranmanesh A, Dobs A, Snyder PJ, Cunningham G, Matsumoto AM, Weber T, Berman N; Testosterone Gel Study Group. Transdermal testosterone gel improves sexual function, mood, muscle strength, and body composition parameters in hypogonadal men. J Clin Endocrinol Metab. 2000 Aug;85(8):2839-53. doi: 10.1210/jcem.85.8.6747.
- Areta JL, Burke LM, Camera DM, West DW, Crawshay S, Moore DR, Stellingwerff T, Phillips SM, Hawley JA, Coffey VG. Reduced resting skeletal muscle protein synthesis is rescued by resistance exercise and protein ingestion following short-term energy deficit. Am J Physiol Endocrinol Metab. 2014 Apr 15;306(8):E989-97. doi: 10.1152/ajpendo.00590.2013. Epub 2014 Mar 4.
- Pasiakos SM, Margolis LM, McClung JP, Cao JJ, Whigham LD, Combs GF, Young AJ. Whole-body protein turnover response to short-term high-protein diets during weight loss: a randomized controlled trial. Int J Obes (Lond). 2014 Jul;38(7):1015-8. doi: 10.1038/ijo.2013.197. Epub 2013 Oct 29.
- Cardello AV, Schutz HG, Lesher LL, Merrill E. Development and testing of a labeled magnitude scale of perceived satiety. Appetite. 2005 Feb;44(1):1-13. doi: 10.1016/j.appet.2004.05.007. Epub 2004 Nov 13.
- Bhasin S, Woodhouse L, Casaburi R, Singh AB, Bhasin D, Berman N, Chen X, Yarasheski KE, Magliano L, Dzekov C, Dzekov J, Bross R, Phillips J, Sinha-Hikim I, Shen R, Storer TW. Testosterone dose-response relationships in healthy young men. Am J Physiol Endocrinol Metab. 2001 Dec;281(6):E1172-81. doi: 10.1152/ajpendo.2001.281.6.E1172.
- Pasiakos SM, Margolis LM, Orr JS. Optimized dietary strategies to protect skeletal muscle mass during periods of unavoidable energy deficit. FASEB J. 2015 Apr;29(4):1136-42. doi: 10.1096/fj.14-266890. Epub 2014 Dec 30.
- Lieberman HR, Thompson LA, Caruso CM, Niro PJ, Mahoney CR, McClung JP, Caron GR. The catecholamine neurotransmitter precursor tyrosine increases anger during exposure to severe psychological stress. Psychopharmacology (Berl). 2015 Mar;232(5):943-51. doi: 10.1007/s00213-014-3727-7. Epub 2014 Sep 16.
- Friedl KE, Moore RJ, Hoyt RW, Marchitelli LJ, Martinez-Lopez LE, Askew EW. Endocrine markers of semistarvation in healthy lean men in a multistressor environment. J Appl Physiol (1985). 2000 May;88(5):1820-30. doi: 10.1152/jappl.2000.88.5.1820.
- Opstad PK. The hypothalamo-pituitary regulation of androgen secretion in young men after prolonged physical stress combined with energy and sleep deprivation. Acta Endocrinol (Copenh). 1992 Sep;127(3):231-6. doi: 10.1530/acta.0.1270231.
- Henning PC, Scofield DE, Spiering BA, Staab JS, Matheny RW Jr, Smith MA, Bhasin S, Nindl BC. Recovery of endocrine and inflammatory mediators following an extended energy deficit. J Clin Endocrinol Metab. 2014 Mar;99(3):956-64. doi: 10.1210/jc.2013-3046. Epub 2013 Dec 11.
- Nindl BC, Friedl KE, Frykman PN, Marchitelli LJ, Shippee RL, Patton JF. Physical performance and metabolic recovery among lean, healthy men following a prolonged energy deficit. Int J Sports Med. 1997 Jul;18(5):317-24. doi: 10.1055/s-2007-972640.
- Nindl BC, Alemany JA, Kellogg MD, Rood J, Allison SA, Young AJ, Montain SJ. Utility of circulating IGF-I as a biomarker for assessing body composition changes in men during periods of high physical activity superimposed upon energy and sleep restriction. J Appl Physiol (1985). 2007 Jul;103(1):340-6. doi: 10.1152/japplphysiol.01321.2006. Epub 2007 Apr 5.
- Carbone JW, McClung JP, Pasiakos SM. Skeletal muscle responses to negative energy balance: effects of dietary protein. Adv Nutr. 2012 Mar 1;3(2):119-26. doi: 10.3945/an.111.001792.
- Knapik JJ, Ang P, Meiselman H, Johnson W, Kirk J, Bensel C, Hanlon W. Soldier performance and strenuous road marching: influence of load mass and load distribution. Mil Med. 1997 Jan;162(1):62-7.
- Knapik JJ, Reynolds KL, Harman E. Soldier load carriage: historical, physiological, biomechanical, and medical aspects. Mil Med. 2004 Jan;169(1):45-56. doi: 10.7205/milmed.169.1.45.
- Roy TC, Ritland BM, Knapik JJ, Sharp MA. Lifting tasks are associated with injuries during the early portion of a deployment to Afghanistan. Mil Med. 2012 Jun;177(6):716-22. doi: 10.7205/milmed-d-11-00402.
- Christensen PA, Jacobsen O, Thorlund JB, Madsen T, Moller C, Jensen C, Suetta C, Aagaard P. Changes in maximum muscle strength and rapid muscle force characteristics after long-term special support and reconnaissance missions: a preliminary report. Mil Med. 2008 Sep;173(9):889-94. doi: 10.7205/milmed.173.9.889.
- Alemany JA, Nindl BC, Kellogg MD, Tharion WJ, Young AJ, Montain SJ. Effects of dietary protein content on IGF-I, testosterone, and body composition during 8 days of severe energy deficit and arduous physical activity. J Appl Physiol (1985). 2008 Jul;105(1):58-64. doi: 10.1152/japplphysiol.00005.2008. Epub 2008 May 1.
- Hoyt RW, Opstad PK, Haugen AH, DeLany JP, Cymerman A, Friedl KE. Negative energy balance in male and female rangers: effects of 7 d of sustained exercise and food deprivation. Am J Clin Nutr. 2006 May;83(5):1068-75. doi: 10.1093/ajcn/83.5.1068.
- Margolis LM, Rood J, Champagne C, Young AJ, Castellani JW. Energy balance and body composition during US Army special forces training. Appl Physiol Nutr Metab. 2013 Apr;38(4):396-400. doi: 10.1139/apnm-2012-0323. Epub 2013 Apr 3.
- Nindl BC, Barnes BR, Alemany JA, Frykman PN, Shippee RL, Friedl KE. Physiological consequences of U.S. Army Ranger training. Med Sci Sports Exerc. 2007 Aug;39(8):1380-7. doi: 10.1249/MSS.0b013e318067e2f7.
- Nindl BC, Rarick KR, Castellani JW, Tuckow AP, Patton JF, Young AJ, Montain SJ. Altered secretion of growth hormone and luteinizing hormone after 84 h of sustained physical exertion superimposed on caloric and sleep restriction. J Appl Physiol (1985). 2006 Jan;100(1):120-8. doi: 10.1152/japplphysiol.01415.2004. Epub 2005 Sep 1.
- Nindl BC, Leone CD, Tharion WJ, Johnson RF, Castellani JW, Patton JF, Montain SJ. Physical performance responses during 72 h of military operational stress. Med Sci Sports Exerc. 2002 Nov;34(11):1814-22. doi: 10.1097/00005768-200211000-00019.
- Welsh TT, Alemany JA, Montain SJ, Frykman PN, Tuckow AP, Young AJ, Nindl BC. Effects of intensified military field training on jumping performance. Int J Sports Med. 2008 Jan;29(1):45-52. doi: 10.1055/s-2007-964970. Epub 2007 Sep 18.
- Thorlund JB, Jakobsen O, Madsen T, Christensen PA, Nedergaard A, Andersen JL, Suetta C, Aagaard P. Changes in muscle strength and morphology after muscle unloading in Special Forces missions. Scand J Med Sci Sports. 2011 Dec;21(6):e56-63. doi: 10.1111/j.1600-0838.2010.01149.x. Epub 2010 Jun 18.
- Pasiakos SM, Cao JJ, Margolis LM, Sauter ER, Whigham LD, McClung JP, Rood JC, Carbone JW, Combs GF Jr, Young AJ. Effects of high-protein diets on fat-free mass and muscle protein synthesis following weight loss: a randomized controlled trial. FASEB J. 2013 Sep;27(9):3837-47. doi: 10.1096/fj.13-230227. Epub 2013 Jun 5.
- Pasiakos SM, Austin KG, Lieberman HR, Askew EW. Efficacy and safety of protein supplements for U.S. Armed Forces personnel: consensus statement. J Nutr. 2013 Nov;143(11):1811S-1814S. doi: 10.3945/jn.113.176859. Epub 2013 Sep 11.
- Margolis LM, Murphy NE, Martini S, Spitz MG, Thrane I, McGraw SM, Blatny JM, Castellani JW, Rood JC, Young AJ, Montain SJ, Gundersen Y, Pasiakos SM. Effects of winter military training on energy balance, whole-body protein balance, muscle damage, soreness, and physical performance. Appl Physiol Nutr Metab. 2014 Dec;39(12):1395-401. doi: 10.1139/apnm-2014-0212.
- Finkelstein JS, Yu EW, Burnett-Bowie SA. Gonadal steroids and body composition, strength, and sexual function in men. N Engl J Med. 2013 Dec 19;369(25):2457. doi: 10.1056/NEJMc1313169. No abstract available.
- Henning PC, Margolis LM, McClung JP, Young AJ, Pasiakos SM. High protein diets do not attenuate decrements in testosterone and IGF-I during energy deficit. Metabolism. 2014 May;63(5):628-32. doi: 10.1016/j.metabol.2014.02.007. Epub 2014 Feb 17.
- Murphy MG, Plunkett LM, Gertz BJ, He W, Wittreich J, Polvino WM, Clemmons DR. MK-677, an orally active growth hormone secretagogue, reverses diet-induced catabolism. J Clin Endocrinol Metab. 1998 Feb;83(2):320-5. doi: 10.1210/jcem.83.2.4551.
- Clemmons DR, Smith-Banks A, Underwood LE. Reversal of diet-induced catabolism by infusion of recombinant insulin-like growth factor-I in humans. J Clin Endocrinol Metab. 1992 Jul;75(1):234-8. doi: 10.1210/jcem.75.1.1619015.
- Kupfer SR, Underwood LE, Baxter RC, Clemmons DR. Enhancement of the anabolic effects of growth hormone and insulin-like growth factor I by use of both agents simultaneously. J Clin Invest. 1993 Feb;91(2):391-6. doi: 10.1172/JCI116212.
- Dulloo AG, Jacquet J, Montani JP. How dieting makes some fatter: from a perspective of human body composition autoregulation. Proc Nutr Soc. 2012 Aug;71(3):379-89. doi: 10.1017/S0029665112000225. Epub 2012 Apr 5.
- Dulloo AG, Jacquet J, Girardier L. Poststarvation hyperphagia and body fat overshooting in humans: a role for feedback signals from lean and fat tissues. Am J Clin Nutr. 1997 Mar;65(3):717-23. doi: 10.1093/ajcn/65.3.717.
- Pescatello LS, Devaney JM, Hubal MJ, Thompson PD, Hoffman EP. Highlights from the functional single nucleotide polymorphisms associated with human muscle size and strength or FAMuSS study. Biomed Res Int. 2013;2013:643575. doi: 10.1155/2013/643575. Epub 2013 Dec 23.
- Silverman I, Kastuk D, Choi J, Phillips K. Testosterone levels and spatial ability in men. Psychoneuroendocrinology. 1999 Nov;24(8):813-22. doi: 10.1016/s0306-4530(99)00031-1.
- Christiansen K, Knussmann R. Sex hormones and cognitive functioning in men. Neuropsychobiology. 1987;18(1):27-36. doi: 10.1159/000118389.
- Morley JE, Kaiser F, Raum WJ, Perry HM 3rd, Flood JF, Jensen J, Silver AJ, Roberts E. Potentially predictive and manipulable blood serum correlates of aging in the healthy human male: progressive decreases in bioavailable testosterone, dehydroepiandrosterone sulfate, and the ratio of insulin-like growth factor 1 to growth hormone. Proc Natl Acad Sci U S A. 1997 Jul 8;94(14):7537-42. doi: 10.1073/pnas.94.14.7537.
- Moffat SD, Hampson E. A curvilinear relationship between testosterone and spatial cognition in humans: possible influence of hand preference. Psychoneuroendocrinology. 1996 Apr;21(3):323-37. doi: 10.1016/0306-4530(95)00051-8.
- Muller M, Aleman A, Grobbee DE, de Haan EH, van der Schouw YT. Endogenous sex hormone levels and cognitive function in aging men: is there an optimal level? Neurology. 2005 Mar 8;64(5):866-71. doi: 10.1212/01.WNL.0000153072.54068.E3.
- Stanton SJ, Liening SH, Schultheiss OC. Testosterone is positively associated with risk taking in the Iowa Gambling Task. Horm Behav. 2011 Feb;59(2):252-6. doi: 10.1016/j.yhbeh.2010.12.003. Epub 2010 Dec 15.
- Apicella CL, Dreber A, Mollerstrom J. Salivary testosterone change following monetary wins and losses predicts future financial risk-taking. Psychoneuroendocrinology. 2014 Jan;39:58-64. doi: 10.1016/j.psyneuen.2013.09.025. Epub 2013 Oct 6.
- Coates JM, Gurnell M, Sarnyai Z. From molecule to market: steroid hormones and financial risk-taking. Philos Trans R Soc Lond B Biol Sci. 2010 Jan 27;365(1538):331-43. doi: 10.1098/rstb.2009.0193.
- Anderson RA, Martin CW, Kung AW, Everington D, Pun TC, Tan KC, Bancroft J, Sundaram K, Moo-Young AJ, Baird DT. 7Alpha-methyl-19-nortestosterone maintains sexual behavior and mood in hypogonadal men. J Clin Endocrinol Metab. 1999 Oct;84(10):3556-62. doi: 10.1210/jcem.84.10.6028.
- O'Carroll R, Shapiro C, Bancroft J. Androgens, behaviour and nocturnal erection in hypogonadal men: the effects of varying the replacement dose. Clin Endocrinol (Oxf). 1985 Nov;23(5):527-38. doi: 10.1111/j.1365-2265.1985.tb01113.x.
- Salmimies P, Kockott G, Pirke KM, Vogt HJ, Schill WB. Effects of testosterone replacement on sexual behavior in hypogonadal men. Arch Sex Behav. 1982 Aug;11(4):345-53. doi: 10.1007/BF01541595.
- Wright ND, Bahrami B, Johnson E, Di Malta G, Rees G, Frith CD, Dolan RJ. Testosterone disrupts human collaboration by increasing egocentric choices. Proc Biol Sci. 2012 Jun 7;279(1736):2275-80. doi: 10.1098/rspb.2011.2523. Epub 2012 Feb 1.
- Zak PJ, Kurzban R, Ahmadi S, Swerdloff RS, Park J, Efremidze L, Redwine K, Morgan K, Matzner W. Testosterone administration decreases generosity in the ultimatum game. PLoS One. 2009 Dec 16;4(12):e8330. doi: 10.1371/journal.pone.0008330.
- Baker LA, Pearcey SM, Dabbs JM Jr. Testosterone, alcohol, and civil and rough conflict resolution strategies in lesbian couples. J Homosex. 2002;42(4):77-88. doi: 10.1300/J082v42n04_05.
- Johnson RT, Breedlove SM. Human trust: testosterone raises suspicion. Proc Natl Acad Sci U S A. 2010 Jun 22;107(25):11149-50. doi: 10.1073/pnas.1005376107. Epub 2010 Jun 10. No abstract available.
- van Honk J, Tuiten A, Verbaten R, van den Hout M, Koppeschaar H, Thijssen J, de Haan E. Correlations among salivary testosterone, mood, and selective attention to threat in humans. Horm Behav. 1999 Aug;36(1):17-24. doi: 10.1006/hbeh.1999.1521.
- Luboshitzky R, Shen-Orr Z, Herer P. Middle-aged men secrete less testosterone at night than young healthy men. J Clin Endocrinol Metab. 2003 Jul;88(7):3160-6. doi: 10.1210/jc.2002-021920.
- Penev PD. Association between sleep and morning testosterone levels in older men. Sleep. 2007 Apr;30(4):427-32. doi: 10.1093/sleep/30.4.427.
- Wittert G. The relationship between sleep disorders and testosterone in men. Asian J Androl. 2014 Mar-Apr;16(2):262-5. doi: 10.4103/1008-682X.122586.
- Ebstein RP, Israel S, Chew SH, Zhong S, Knafo A. Genetics of human social behavior. Neuron. 2010 Mar 25;65(6):831-44. doi: 10.1016/j.neuron.2010.02.020.
- Bartels M, Van den Berg M, Sluyter F, Boomsma DI, de Geus EJ. Heritability of cortisol levels: review and simultaneous analysis of twin studies. Psychoneuroendocrinology. 2003 Feb;28(2):121-37. doi: 10.1016/s0306-4530(02)00003-3.
- Uhart M, McCaul ME, Oswald LM, Choi L, Wand GS. GABRA6 gene polymorphism and an attenuated stress response. Mol Psychiatry. 2004 Nov;9(11):998-1006. doi: 10.1038/sj.mp.4001535.
- Zhang L, Rao F, Wessel J, Kennedy BP, Rana BK, Taupenot L, Lillie EO, Cockburn M, Schork NJ, Ziegler MG, O'Connor DT. Functional allelic heterogeneity and pleiotropy of a repeat polymorphism in tyrosine hydroxylase: prediction of catecholamines and response to stress in twins. Physiol Genomics. 2004 Nov 17;19(3):277-91. doi: 10.1152/physiolgenomics.00151.2004. Epub 2004 Sep 14.
- Sumithran P, Proietto J. The defence of body weight: a physiological basis for weight regain after weight loss. Clin Sci (Lond). 2013 Feb;124(4):231-41. doi: 10.1042/CS20120223.
- Montani JP, Schutz Y, Dulloo AG. Dieting and weight cycling as risk factors for cardiometabolic diseases: who is really at risk? Obes Rev. 2015 Feb;16 Suppl 1:7-18. doi: 10.1111/obr.12251.
- Liu J, Prudom CE, Nass R, Pezzoli SS, Oliveri MC, Johnson ML, Veldhuis P, Gordon DA, Howard AD, Witcher DR, Geysen HM, Gaylinn BD, Thorner MO. Novel ghrelin assays provide evidence for independent regulation of ghrelin acylation and secretion in healthy young men. J Clin Endocrinol Metab. 2008 May;93(5):1980-7. doi: 10.1210/jc.2007-2235. Epub 2008 Mar 18.
- Greenman Y, Rouach V, Limor R, Gilad S, Stern N. Testosterone is a strong correlate of ghrelin levels in men and postmenopausal women. Neuroendocrinology. 2009;89(1):79-85. doi: 10.1159/000151768. Epub 2008 Aug 28.
- Pagotto U, Gambineri A, Pelusi C, Genghini S, Cacciari M, Otto B, Castaneda T, Tschop M, Pasquali R. Testosterone replacement therapy restores normal ghrelin in hypogonadal men. J Clin Endocrinol Metab. 2003 Sep;88(9):4139-43. doi: 10.1210/jc.2003-030554.
- Jockenhovel F, Blum WF, Vogel E, Englaro P, Muller-Wieland D, Reinwein D, Rascher W, Krone W. Testosterone substitution normalizes elevated serum leptin levels in hypogonadal men. J Clin Endocrinol Metab. 1997 Aug;82(8):2510-3. doi: 10.1210/jcem.82.8.4174.
- Lambert GP. Stress-induced gastrointestinal barrier dysfunction and its inflammatory effects. J Anim Sci. 2009 Apr;87(14 Suppl):E101-8. doi: 10.2527/jas.2008-1339. Epub 2008 Sep 12.
- Teshima CW, Meddings JB. The measurement and clinical significance of intestinal permeability. Curr Gastroenterol Rep. 2008 Oct;10(5):443-9. doi: 10.1007/s11894-008-0083-y.
- Baumgart DC, Dignass AU. Intestinal barrier function. Curr Opin Clin Nutr Metab Care. 2002 Nov;5(6):685-94. doi: 10.1097/00075197-200211000-00012.
- Forchielli ML, Walker WA. The effect of protective nutrients on mucosal defense in the immature intestine. Acta Paediatr Suppl. 2005 Oct;94(449):74-83. doi: 10.1111/j.1651-2227.2005.tb02159.x.
- McClung JP, Karl JP. Iron deficiency and obesity: the contribution of inflammation and diminished iron absorption. Nutr Rev. 2009 Feb;67(2):100-4. doi: 10.1111/j.1753-4887.2008.00145.x.
- Deplancke B, Vidal O, Ganessunker D, Donovan SM, Mackie RI, Gaskins HR. Selective growth of mucolytic bacteria including Clostridium perfringens in a neonatal piglet model of total parenteral nutrition. Am J Clin Nutr. 2002 Nov;76(5):1117-25. doi: 10.1093/ajcn/76.5.1117.
- Sonoyama K, Fujiwara R, Takemura N, Ogasawara T, Watanabe J, Ito H, Morita T. Response of gut microbiota to fasting and hibernation in Syrian hamsters. Appl Environ Microbiol. 2009 Oct;75(20):6451-6. doi: 10.1128/AEM.00692-09. Epub 2009 Aug 21.
- Plaisancie P, Ducroc R, El Homsi M, Tsocas A, Guilmeau S, Zoghbi S, Thibaudeau O, Bado A. Luminal leptin activates mucin-secreting goblet cells in the large bowel. Am J Physiol Gastrointest Liver Physiol. 2006 Apr;290(4):G805-12. doi: 10.1152/ajpgi.00433.2005. Epub 2006 Feb 2.
- Ravussin Y, Koren O, Spor A, LeDuc C, Gutman R, Stombaugh J, Knight R, Ley RE, Leibel RL. Responses of gut microbiota to diet composition and weight loss in lean and obese mice. Obesity (Silver Spring). 2012 Apr;20(4):738-47. doi: 10.1038/oby.2011.111. Epub 2011 May 19.
- Braniste V, Leveque M, Buisson-Brenac C, Bueno L, Fioramonti J, Houdeau E. Oestradiol decreases colonic permeability through oestrogen receptor beta-mediated up-regulation of occludin and junctional adhesion molecule-A in epithelial cells. J Physiol. 2009 Jul 1;587(Pt 13):3317-28. doi: 10.1113/jphysiol.2009.169300. Epub 2009 May 11.
- Meng J, Mostaghel EA, Vakar-Lopez F, Montgomery B, True L, Nelson PS. Testosterone regulates tight junction proteins and influences prostatic autoimmune responses. Horm Cancer. 2011 Jun;2(3):145-56. doi: 10.1007/s12672-010-0063-1.
- Markle JG, Frank DN, Mortin-Toth S, Robertson CE, Feazel LM, Rolle-Kampczyk U, von Bergen M, McCoy KD, Macpherson AJ, Danska JS. Sex differences in the gut microbiome drive hormone-dependent regulation of autoimmunity. Science. 2013 Mar 1;339(6123):1084-8. doi: 10.1126/science.1233521. Epub 2013 Jan 17.
- Lohman TG, Harris M, Teixeira PJ, Weiss L. Assessing body composition and changes in body composition. Another look at dual-energy X-ray absorptiometry. Ann N Y Acad Sci. 2000 May;904:45-54. doi: 10.1111/j.1749-6632.2000.tb06420.x.
- Coviello AD, Kaplan B, Lakshman KM, Chen T, Singh AB, Bhasin S. Effects of graded doses of testosterone on erythropoiesis in healthy young and older men. J Clin Endocrinol Metab. 2008 Mar;93(3):914-9. doi: 10.1210/jc.2007-1692. Epub 2007 Dec 26.
- Lakshman KM, Kaplan B, Travison TG, Basaria S, Knapp PE, Singh AB, LaValley MP, Mazer NA, Bhasin S. The effects of injected testosterone dose and age on the conversion of testosterone to estradiol and dihydrotestosterone in young and older men. J Clin Endocrinol Metab. 2010 Aug;95(8):3955-64. doi: 10.1210/jc.2010-0102. Epub 2010 Jun 9.
- Lo S, Russell JC, Taylor AW. Determination of glycogen in small tissue samples. J Appl Physiol. 1970 Feb;28(2):234-6. doi: 10.1152/jappl.1970.28.2.234. No abstract available.
- Carbone JW, Margolis LM, McClung JP, Cao JJ, Murphy NE, Sauter ER, Combs GF Jr, Young AJ, Pasiakos SM. Effects of energy deficit, dietary protein, and feeding on intracellular regulators of skeletal muscle proteolysis. FASEB J. 2013 Dec;27(12):5104-11. doi: 10.1096/fj.13-239228. Epub 2013 Aug 21.
- Spiering BA, Kraemer WJ, Vingren JL, Ratamess NA, Anderson JM, Armstrong LE, Nindl BC, Volek JS, Hakkinen K, Maresh CM. Elevated endogenous testosterone concentrations potentiate muscle androgen receptor responses to resistance exercise. J Steroid Biochem Mol Biol. 2009 Apr;114(3-5):195-9. doi: 10.1016/j.jsbmb.2009.02.005. Epub 2009 Feb 21.
- Price JC, Holmes WE, Li KW, Floreani NA, Neese RA, Turner SM, Hellerstein MK. Measurement of human plasma proteome dynamics with (2)H(2)O and liquid chromatography tandem mass spectrometry. Anal Biochem. 2012 Jan 1;420(1):73-83. doi: 10.1016/j.ab.2011.09.007. Epub 2011 Sep 14.
- Jequier E, Acheson K, Schutz Y. Assessment of energy expenditure and fuel utilization in man. Annu Rev Nutr. 1987;7:187-208. doi: 10.1146/annurev.nu.07.070187.001155. No abstract available.
- Lieberman HR, Bathalon GP, Falco CM, Kramer FM, Morgan CA 3rd, Niro P. Severe decrements in cognition function and mood induced by sleep loss, heat, dehydration, and undernutrition during simulated combat. Biol Psychiatry. 2005 Feb 15;57(4):422-9. doi: 10.1016/j.biopsych.2004.11.014.
- Lieberman HR, Caruso CM, Niro PJ, Adam GE, Kellogg MD, Nindl BC, Kramer FM. A double-blind, placebo-controlled test of 2 d of calorie deprivation: effects on cognition, activity, sleep, and interstitial glucose concentrations. Am J Clin Nutr. 2008 Sep;88(3):667-76. doi: 10.1093/ajcn/88.3.667.
- Butcher J, Graham J, Tellegen A, Dahlstrom W, Kaemmer B. Minnesota Multiphasic Personality Inventory-2 (MMPI-2): Manual for administration, scoring, and interpretation 2nd ed. Minneapolis, MN: University of Minnesota Press; 2001.
- Weiner IB, Greene RL. Handbook of Personality Assessment. Hoboken, NJ: Wiley; 2006.
- Spiro A, Butcher JN, Levenson RM, Aldwin CM, Bossé R. Change and stability in personality: A 5-year study of the MMPI-2 in older men. In: Butcher JN, ed. Fundamentals of MMPI-2: Research and application Minneapolis, MN: University of Minnesota Press; 2000:443-462.
- Keo-Meier CL, Herman LI, Reisner SL, Pardo ST, Sharp C, Babcock JC. Testosterone treatment and MMPI-2 improvement in transgender men: a prospective controlled study. J Consult Clin Psychol. 2015 Feb;83(1):143-56. doi: 10.1037/a0037599. Epub 2014 Aug 11.
- O'Connor DB, Archer J, Wu FC. Effects of testosterone on mood, aggression, and sexual behavior in young men: a double-blind, placebo-controlled, cross-over study. J Clin Endocrinol Metab. 2004 Jun;89(6):2837-45. doi: 10.1210/jc.2003-031354.
- McNair DM, Lorr M, Droppleman LF. Profile of Mood States Manual. San Diego, CA: Educational and Industrial Testing Service; 1971.
- Banderet LE, Lieberman HR. Treatment with tyrosine, a neurotransmitter precursor, reduces environmental stress in humans. Brain Res Bull. 1989 Apr;22(4):759-62. doi: 10.1016/0361-9230(89)90096-8.
- Lieberman HR, Bathalon GP, Falco CM, et al. The Fog of War: Documenting Cognitive Decrements Associated with the Stress of Combat. 2002.
- Lieberman HR, Falco CM, Slade SS. Carbohydrate administration during a day of sustained aerobic activity improves vigilance, as assessed by a novel ambulatory monitoring device, and mood. Am J Clin Nutr. 2002 Jul;76(1):120-7. doi: 10.1093/ajcn/76.1.120.
- Lieberman HR, Tharion WJ, Shukitt-Hale B, Speckman KL, Tulley R. Effects of caffeine, sleep loss, and stress on cognitive performance and mood during U.S. Navy SEAL training. Sea-Air-Land. Psychopharmacology (Berl). 2002 Nov;164(3):250-61. doi: 10.1007/s00213-002-1217-9. Epub 2002 Sep 5.
- Shukitt-Hale B, Askew EW, Lieberman HR. Effects of 30 days of undernutrition on reaction time, moods, and symptoms. Physiol Behav. 1997 Oct;62(4):783-9. doi: 10.1016/s0031-9384(97)00236-9.
- Lejuez CW, Read JP, Kahler CW, Richards JB, Ramsey SE, Stuart GL, Strong DR, Brown RA. Evaluation of a behavioral measure of risk taking: the Balloon Analogue Risk Task (BART). J Exp Psychol Appl. 2002 Jun;8(2):75-84. doi: 10.1037//1076-898x.8.2.75.
- Burnham TC. High-testosterone men reject low ultimatum game offers. Proc Biol Sci. 2007 Sep 22;274(1623):2327-30. doi: 10.1098/rspb.2007.0546.
- Prevost M, Carrier ME, Chowne G, Zelkowitz P, Joseph L, Gold I. The Reading the Mind in the Eyes test: validation of a French version and exploration of cultural variations in a multi-ethnic city. Cogn Neuropsychiatry. 2014;19(3):189-204. doi: 10.1080/13546805.2013.823859. Epub 2013 Aug 13.
- Fine BJ, Kobrick JL, Lieberman HR, Marlowe B, Riley RH, Tharion WJ. Effects of caffeine or diphenhydramine on visual vigilance. Psychopharmacology (Berl). 1994 Mar;114(2):233-8. doi: 10.1007/BF02244842.
- Dinges DF, Powell JW. Microcomputer analyses of performance on a portable, simple, visual RT task during sustained operations. Vol 171985:652-655.
- Baddeley AD. A 3 min reasoning test based on grammatical transformation. Psychon Sci. 1968;10(10):341-342.
- Vartanian O, Mandel DR, Duncan M. Money or life: Behavioral and neural context effects on choice under uncertainty. Journal of Neuroscience, Psychology, and Economics. 2011;4(1):25-36.
- Lotze M, Veit R, Anders S, Birbaumer N. Evidence for a different role of the ventral and dorsal medial prefrontal cortex for social reactive aggression: An interactive fMRI study. Neuroimage. 2007 Jan 1;34(1):470-8. doi: 10.1016/j.neuroimage.2006.09.028. Epub 2006 Oct 27.
- Bush G, Shin LM. The Multi-Source Interference Task: an fMRI task that reliably activates the cingulo-frontal-parietal cognitive/attention network. Nat Protoc. 2006;1(1):308-13. doi: 10.1038/nprot.2006.48.
- Carter CS, Braver TS, Barch DM, Botvinick MM, Noll D, Cohen JD. Anterior cingulate cortex, error detection, and the online monitoring of performance. Science. 1998 May 1;280(5364):747-9. doi: 10.1126/science.280.5364.747.
- Goetz SM, Tang L, Thomason ME, Diamond MP, Hariri AR, Carre JM. Testosterone rapidly increases neural reactivity to threat in healthy men: a novel two-step pharmacological challenge paradigm. Biol Psychiatry. 2014 Aug 15;76(4):324-31. doi: 10.1016/j.biopsych.2014.01.016. Epub 2014 Jan 29.
- Kuczynski J, Lauber CL, Walters WA, Parfrey LW, Clemente JC, Gevers D, Knight R. Experimental and analytical tools for studying the human microbiome. Nat Rev Genet. 2011 Dec 16;13(1):47-58. doi: 10.1038/nrg3129.
- Possemiers S, Verthe K, Uyttendaele S, Verstraete W. PCR-DGGE-based quantification of stability of the microbial community in a simulator of the human intestinal microbial ecosystem. FEMS Microbiol Ecol. 2004 Sep 1;49(3):495-507. doi: 10.1016/j.femsec.2004.05.002.
- Grootjans J, Thuijls G, Verdam F, Derikx JP, Lenaerts K, Buurman WA. Non-invasive assessment of barrier integrity and function of the human gut. World J Gastrointest Surg. 2010 Mar 27;2(3):61-9. doi: 10.4240/wjgs.v2.i3.61.
- Howard EE, Shankaran M, Evans WJ, Berryman CE, Margolis LM, Lieberman HR, Karl JP, Young AJ, Montano MA, Matthews MD, Bizieff A, Nyangao E, Mohammed H, Harris MN, Hellerstein MK, Rood JC, Pasiakos SM. Effects of Testosterone on Mixed-Muscle Protein Synthesis and Proteome Dynamics During Energy Deficit. J Clin Endocrinol Metab. 2022 Jul 14;107(8):e3254-e3263. doi: 10.1210/clinem/dgac295.
- Karl JP, Berryman CE, Harris MN, Lieberman HR, Gadde KM, Rood JC, Pasiakos SM. Effects of Testosterone Supplementation on Ghrelin and Appetite During and After Severe Energy Deficit in Healthy Men. J Endocr Soc. 2020 Mar 3;4(4):bvaa024. doi: 10.1210/jendso/bvaa024. eCollection 2020 Apr 1.
- Hennigar SR, Berryman CE, Harris MN, Karl JP, Lieberman HR, McClung JP, Rood JC, Pasiakos SM. Testosterone Administration During Energy Deficit Suppresses Hepcidin and Increases Iron Availability for Erythropoiesis. J Clin Endocrinol Metab. 2020 Apr 1;105(4):dgz316. doi: 10.1210/clinem/dgz316.
- Pasiakos SM, Berryman CE, Karl JP, Lieberman HR, Orr JS, Margolis LM, Caldwell JA, Young AJ, Montano MA, Evans WJ, Vartanian O, Carmichael OT, Gadde KM, Harris M, Rood JC. Physiological and psychological effects of testosterone during severe energy deficit and recovery: A study protocol for a randomized, placebo-controlled trial for Optimizing Performance for Soldiers (OPS). Contemp Clin Trials. 2017 Jul;58:47-57. doi: 10.1016/j.cct.2017.05.001. Epub 2017 May 4.
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)
2016年4月1日
初级完成 (实际的)
2017年12月1日
研究完成 (实际的)
2017年12月1日
研究注册日期
首次提交
2016年3月31日
首先提交符合 QC 标准的
2016年4月5日
首次发布 (估计)
2016年4月12日
研究记录更新
最后更新发布 (实际的)
2019年1月16日
上次提交的符合 QC 标准的更新
2019年1月3日
最后验证
2019年1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.
芝麻油的临床试验
-
Beni-Suef UniversityUniversity of Arizona; Maternity and Children Hospital, Makkah完全的