The Effects of Testosterone and Nutritional Supplementation in the Undernourished Elderly

Summary

The purpose of this study is to determine what effect treatment for one year with testosterone and a nutritional supplement, alone and combined, has on the adverse effects of under-nutrition in community-dwelling older men and women.

Timeline

Start

2003-07

Primary completion

—

Completion

2007-02

Publications

• Background Evans WJ, Campbell WW. Sarcopenia and age-related changes in body composition and functional capacity. J Nutr. 1993 Feb;123(2 Suppl):465-8. doi: 10.1093/jn/123.suppl_2.465.
• Background Tenover JS. Androgen replacement therapy to reverse and/or prevent age-associated sarcopenia in men. Baillieres Clin Endocrinol Metab. 1998 Oct;12(3):419-25. doi: 10.1016/s0950-351x(98)80153-5.
• Background Roshan S, Nader S, Orlander P. Review: Ageing and hormones. Eur J Clin Invest. 1999 Mar;29(3):210-3. doi: 10.1046/j.1365-2362.1999.00436.x.
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• Background Newman AB, Yanez D, Harris T, Duxbury A, Enright PL, Fried LP; Cardiovascular Study Research Group. Weight change in old age and its association with mortality. J Am Geriatr Soc. 2001 Oct;49(10):1309-18. doi: 10.1046/j.1532-5415.2001.49258.x.
• Background MacIntosh C, Morley JE, Chapman IM. The anorexia of aging. Nutrition. 2000 Oct;16(10):983-95. doi: 10.1016/s0899-9007(00)00405-6. No abstract available.
• Background Morley JE. Anorexia in older persons: epidemiology and optimal treatment. Drugs Aging. 1996 Feb;8(2):134-55. doi: 10.2165/00002512-199608020-00007.
• Background Visvanathan R, Macintosh C, Callary M, Penhall R, Horowitz M, Chapman I. The nutritional status of 250 older Australian recipients of domiciliary care services and its association with outcomes at 12 months. J Am Geriatr Soc. 2003 Jul;51(7):1007-11. doi: 10.1046/j.1365-2389.2003.51317.x.
• Background Morley JE. Testosterone replacement and the physiologic aspects of aging in men. Mayo Clin Proc. 2000 Jan;75 Suppl:S83-7.
• Background Melton LJ 3rd, Khosla S, Riggs BL. Epidemiology of sarcopenia. Mayo Clin Proc. 2000 Jan;75 Suppl:S10-2; discussion S12-3.
• Background Roubenoff R, Rall LC, Veldhuis JD, Kehayias JJ, Rosen C, Nicolson M, Lundgren N, Reichlin S. The relationship between growth hormone kinetics and sarcopenia in postmenopausal women: the role of fat mass and leptin. J Clin Endocrinol Metab. 1998 May;83(5):1502-6. doi: 10.1210/jcem.83.5.4809.
• Background Davis S. Androgen replacement in women: a commentary. J Clin Endocrinol Metab. 1999 Jun;84(6):1886-91. doi: 10.1210/jcem.84.6.5802.
• Background Zumoff B, Strain GW, Miller LK, Rosner W. Twenty-four-hour mean plasma testosterone concentration declines with age in normal premenopausal women. J Clin Endocrinol Metab. 1995 Apr;80(4):1429-30. doi: 10.1210/jcem.80.4.7714119.
• Background Burger HG, Dudley EC, Cui J, Dennerstein L, Hopper JL. A prospective longitudinal study of serum testosterone, dehydroepiandrosterone sulfate, and sex hormone-binding globulin levels through the menopause transition. J Clin Endocrinol Metab. 2000 Aug;85(8):2832-8. doi: 10.1210/jcem.85.8.6740.
• Background Morley JE. Testosterone replacement in older men and women. J Gend Specif Med. 2001;4(2):49-53.
• Background Morley JE. Androgens and aging. Maturitas. 2001 Feb 28;38(1):61-71; discussion 71-3. doi: 10.1016/s0378-5122(00)00192-4.
• Background Davis SR, Burger HG. The rationale for physiological testosterone replacement in women. Baillieres Clin Endocrinol Metab. 1998 Oct;12(3):391-405. doi: 10.1016/s0950-351x(98)80115-8.
• Background Tenover JL. Testosterone replacement therapy in older adult men. Int J Androl. 1999 Oct;22(5):300-6. doi: 10.1046/j.1365-2605.1999.00184.x.
• Background Ly LP, Jimenez M, Zhuang TN, Celermajer DS, Conway AJ, Handelsman DJ. A double-blind, placebo-controlled, randomized clinical trial of transdermal dihydrotestosterone gel on muscular strength, mobility, and quality of life in older men with partial androgen deficiency. J Clin Endocrinol Metab. 2001 Sep;86(9):4078-88. doi: 10.1210/jcem.86.9.7821.
• Background Amory JK, Chansky HA, Chansky KL, Camuso MR, Hoey CT, Anawalt BD, Matsumoto AM, Bremner WJ. Preoperative supraphysiological testosterone in older men undergoing knee replacement surgery. J Am Geriatr Soc. 2002 Oct;50(10):1698-701. doi: 10.1046/j.1532-5415.2002.50462.x.
• Background Bakhshi V, Elliott M, Gentili A, Godschalk M, Mulligan T. Testosterone improves rehabilitation outcomes in ill older men. J Am Geriatr Soc. 2000 May;48(5):550-3. doi: 10.1111/j.1532-5415.2000.tb05002.x.
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• Background Zumoff B, Rosenfeld RS, Strain GW, Levin J, Fukushima DK. Sex differences in the twenty-four-hour mean plasma concentrations of dehydroisoandrosterone (DHA) and dehydroisoandrosterone sulfate (DHAS) and the DHA to DHAS ratio in normal adults. J Clin Endocrinol Metab. 1980 Aug;51(2):330-3. doi: 10.1210/jcem-51-2-330.
• Background Davis SR, McCloud P, Strauss BJ, Burger H. Testosterone enhances estradiol's effects on postmenopausal bone density and sexuality. Maturitas. 1995 Apr;21(3):227-36. doi: 10.1016/0378-5122(94)00898-h.
• Background Davis SR, Tran J. Testosterone influences libido and well being in women. Trends Endocrinol Metab. 2001 Jan-Feb;12(1):33-7. doi: 10.1016/s1043-2760(00)00333-7.
• Background Castelo-Branco C, Vicente JJ, Figueras F, Sanjuan A, Martinez de Osaba MJ, Casals E, Pons F, Balasch J, Vanrell JA. Comparative effects of estrogens plus androgens and tibolone on bone, lipid pattern and sexuality in postmenopausal women. Maturitas. 2000 Feb 15;34(2):161-8. doi: 10.1016/s0378-5122(99)00096-1.
• Background Gruber DM, Sator MO, Kirchengast S, Joura EA, Huber JC. Effect of percutaneous androgen replacement therapy on body composition and body weight in postmenopausal women. Maturitas. 1998 Jun 17;29(3):253-9. doi: 10.1016/s0378-5122(98)00031-0.
• Background Padero MC, Bhasin S, Friedman TC. Androgen supplementation in older women: too much hype, not enough data. J Am Geriatr Soc. 2002 Jun;50(6):1131-40. doi: 10.1046/j.1532-5415.2002.50273.x.
• Background Lobo RA. Androgens in postmenopausal women: production, possible role, and replacement options. Obstet Gynecol Surv. 2001 Jun;56(6):361-76. doi: 10.1097/00006254-200106000-00022.
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• Background Raisz LG, Wiita B, Artis A, Bowen A, Schwartz S, Trahiotis M, Shoukri K, Smith J. Comparison of the effects of estrogen alone and estrogen plus androgen on biochemical markers of bone formation and resorption in postmenopausal women. J Clin Endocrinol Metab. 1996 Jan;81(1):37-43. doi: 10.1210/jcem.81.1.8550780.
• Background Davis SR, Burger HG. Clinical review 82: Androgens and the postmenopausal woman. J Clin Endocrinol Metab. 1996 Aug;81(8):2759-63. doi: 10.1210/jcem.81.8.8768824. No abstract available.
• Background Burger HG, Hailes J, Menelaus M, Nelson J, Hudson B, Balazs N. The management of persistent menopausal symptoms with oestradiol-testosterone implants: clinical, lipid and hormonal results. Maturitas. 1984 Dec;6(4):351-8. doi: 10.1016/0378-5122(84)90008-2.
• Background Burger H, Hailes J, Nelson J, Menelaus M. Effect of combined implants of oestradiol and testosterone on libido in postmenopausal women. Br Med J (Clin Res Ed). 1987 Apr 11;294(6577):936-7. doi: 10.1136/bmj.294.6577.936. No abstract available.
• Background Miller K, Corcoran C, Armstrong C, Caramelli K, Anderson E, Cotton D, Basgoz N, Hirschhorn L, Tuomala R, Schoenfeld D, Daugherty C, Mazer N, Grinspoon S. Transdermal testosterone administration in women with acquired immunodeficiency syndrome wasting: a pilot study. J Clin Endocrinol Metab. 1998 Aug;83(8):2717-25. doi: 10.1210/jcem.83.8.5051.
• Background Mortola JF, Yen SS. The effects of oral dehydroepiandrosterone on endocrine-metabolic parameters in postmenopausal women. J Clin Endocrinol Metab. 1990 Sep;71(3):696-704. doi: 10.1210/jcem-71-3-696.
• Background Casson PR, Santoro N, Elkind-Hirsch K, Carson SA, Hornsby PJ, Abraham G, Buster JE. Postmenopausal dehydroepiandrosterone administration increases free insulin-like growth factor-I and decreases high-density lipoprotein: a six-month trial. Fertil Steril. 1998 Jul;70(1):107-10. doi: 10.1016/s0015-0282(98)00121-6.
• Background Phillips E, Bauman C. Safety surveillance of esterified estrogens-methyltestosterone (Estratest and Estratest HS) replacement therapy in the United States. Clin Ther. 1997 Sep-Oct;19(5):1070-84. doi: 10.1016/s0149-2918(97)80060-4.
• Background Barnhart KT, Freeman E, Grisso JA, Rader DJ, Sammel M, Kapoor S, Nestler JE. The effect of dehydroepiandrosterone supplementation to symptomatic perimenopausal women on serum endocrine profiles, lipid parameters, and health-related quality of life. J Clin Endocrinol Metab. 1999 Nov;84(11):3896-902. doi: 10.1210/jcem.84.11.6153.
• Background Diamond P, Cusan L, Gomez JL, Belanger A, Labrie F. Metabolic effects of 12-month percutaneous dehydroepiandrosterone replacement therapy in postmenopausal women. J Endocrinol. 1996 Sep;150 Suppl:S43-50.
• Background Shifren JL, Braunstein GD, Simon JA, Casson PR, Buster JE, Redmond GP, Burki RE, Ginsburg ES, Rosen RC, Leiblum SR, Caramelli KE, Mazer NA. Transdermal testosterone treatment in women with impaired sexual function after oophorectomy. N Engl J Med. 2000 Sep 7;343(10):682-8. doi: 10.1056/NEJM200009073431002.
• Background Dobs AS, Nguyen T, Pace C, Roberts CP. Differential effects of oral estrogen versus oral estrogen-androgen replacement therapy on body composition in postmenopausal women. J Clin Endocrinol Metab. 2002 Apr;87(4):1509-16. doi: 10.1210/jcem.87.4.8362.
• Background Myers LS, Dixen J, Morrissette D, Carmichael M, Davidson JM. Effects of estrogen, androgen, and progestin on sexual psychophysiology and behavior in postmenopausal women. J Clin Endocrinol Metab. 1990 Apr;70(4):1124-31. doi: 10.1210/jcem-70-4-1124.
• Background Watts NB, Notelovitz M, Timmons MC, Addison WA, Wiita B, Downey LJ. Comparison of oral estrogens and estrogens plus androgen on bone mineral density, menopausal symptoms, and lipid-lipoprotein profiles in surgical menopause. Obstet Gynecol. 1995 Apr;85(4):529-37. doi: 10.1016/0029-7844(94)00448-m.
• Background Penotti M, Sironi L, Cannata L, Vigano P, Casini A, Gabrielli L, Vignali M. Effects of androgen supplementation of hormone replacement therapy on the vascular reactivity of cerebral arteries. Fertil Steril. 2001 Aug;76(2):235-40. doi: 10.1016/s0015-0282(01)01923-9.
• Background Morley JE. Anorexia of aging: physiologic and pathologic. Am J Clin Nutr. 1997 Oct;66(4):760-73. doi: 10.1093/ajcn/66.4.760.
• Background Mathey MF, Siebelink E, de Graaf C, Van Staveren WA. Flavor enhancement of food improves dietary intake and nutritional status of elderly nursing home residents. J Gerontol A Biol Sci Med Sci. 2001 Apr;56(4):M200-5. doi: 10.1093/gerona/56.4.m200.
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• Background Ritchie CS, Burgio KL, Locher JL, Cornwell A, Thomas D, Hardin M, Redden D. Nutritional status of urban homebound older adults. Am J Clin Nutr. 1997 Oct;66(4):815-8. doi: 10.1093/ajcn/66.4.815.
• Background Omran ML, Morley JE. Assessment of protein energy malnutrition in older persons, Part II: Laboratory evaluation. Nutrition. 2000 Feb;16(2):131-40. doi: 10.1016/s0899-9007(99)00251-8.
• Background Lumbers M, New SA, Gibson S, Murphy MC. Nutritional status in elderly female hip fracture patients: comparison with an age-matched home living group attending day centres. Br J Nutr. 2001 Jun;85(6):733-40. doi: 10.1079/bjn2001350.
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• Background Abbasi AA, Rudman D. Undernutrition in the nursing home: prevalence, consequences, causes and prevention. Nutr Rev. 1994 Apr;52(4):113-22. doi: 10.1111/j.1753-4887.1994.tb01403.x.
• Background de Jong N, Chin A Paw MJ, de Groot LC, de Graaf C, Kok FJ, van Staveren WA. Functional biochemical and nutrient indices in frail elderly people are partly affected by dietary supplements but not by exercise. J Nutr. 1999 Nov;129(11):2028-36. doi: 10.1093/jn/129.11.2028.
• Background Lauque S, Arnaud-Battandier F, Mansourian R, Guigoz Y, Paintin M, Nourhashemi F, Vellas B. Protein-energy oral supplementation in malnourished nursing-home residents. A controlled trial. Age Ageing. 2000 Jan;29(1):51-6. doi: 10.1093/ageing/29.1.51.
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• Background Tkatch L, Rapin CH, Rizzoli R, Slosman D, Nydegger V, Vasey H, Bonjour JP. Benefits of oral protein supplementation in elderly patients with fracture of the proximal femur. J Am Coll Nutr. 1992 Oct;11(5):519-25. doi: 10.1080/07315724.1992.10718256.
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• Background Sullivan DH, Patch GA, Walls RC, Lipschitz DA. Impact of nutrition status on morbidity and mortality in a select population of geriatric rehabilitation patients. Am J Clin Nutr. 1990 May;51(5):749-58. doi: 10.1093/ajcn/51.5.749.
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• Background Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
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• Chapman IM, Visvanathan R, Hammond AJ, Morley JE, Field JB, Tai K, Belobrajdic DP, Chen RY, Horowitz M. Effect of testosterone and a nutritional supplement, alone and in combination, on hospital admissions in undernourished older men and women. Am J Clin Nutr. 2009 Mar;89(3):880-9. doi: 10.3945/ajcn.2008.26538. Epub 2009 Jan 14.

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