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MalnutritionPhase 3NCT00117000

The Effects of Testosterone and Nutritional Supplementation in the Undernourished Elderly

A Phase 3 study testing testosterone undecanoate in people with Malnutrition and Aging, run by University of Adelaide at 1 site in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Malnutrition, Aging
What is being tested?
testosterone undecanoate
How many people
200 participants
Where
1 siteAustralia
Study dates
Jul 2003to Feb 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Men and women aged 65 years or older who are under-nourished, as defined by a Mini Nutritional Assessment (MNA) score <24 AND 1 or more of the following: *a body mass index (BMI) of less than 22 kg/m2; *weight loss of > 7.5% in the 3 months before enrolling in the study
  • Living independently in the community (not in a hospital, nursing home or hostel)
  • Understand and sign informed consent document, able to communicate with the investigator, and understand and comply with the requirements of the study.
  • Women who are taking oestrogen or other hormone replacement therapy (HRT) may take part (see exclusion criteria for exceptions), as may women who are not taking HRT. If a woman is taking HRT she must have been on a stable dose for at least 3 months before enrolment in the study. If not on HRT, she must not have been taking it for at least 3 months before enrolment.

Who cannot join

  • Dementia as indicated by a Folstein's Mini Mental State Examination (MMSE) score of < 23
  • Elevated haematocrit (HCT) levels (>50%)
  • Past or present history of prostatic cancer in men (Prostate Specific Antigen (PSA) levels [> age-related normal range and/or irregular prostate on prostate examination]) or breast cancer.
  • Pre-existing androgenic signs or symptoms in women of concern to either subject or investigator (deep voice, hirsutism, acne, androgenic hair loss).
  • Depression (Yesavage Geriatric Depression Scale (GDS) Score > 11)
  • Inability to attend DEXA scan or complete other requirements of the study
Show all 13Show fewer
  • Significant cardiac failure (NYHA Class III and above)
  • Significantly abnormal liver function tests (ALT, GGT, bilirubin or ALP more than 2 times the upper limit of normal)
  • Nephrotic syndrome; 24h urine protein excretion > 3 grams (if baseline urinalysis reveals > 1+ proteinuria, quantification will be performed) AND/OR calculated creatinine clearance (by the equation of Baracskay and Jarjoura for ambulatory elderly subjects [Cr clearance = 4.4/serum creatinine (mmol/L) + (88-age)](63) < 30 ml/min) AND/OR serum creatinine concentration > 0.2mmol/l.
  • Amputee (body mass index, creatinine clearance and body composition estimations inaccurate).
  • Any disease, which in the opinion of the investigator is likely to lead to death within one year
  • Testosterone or other androgen therapy (including DHEA and tibolone) in the four months before starting the study.
  • Medication with cyclosporin or barbiturates

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

Other trials in Australia

About this study

Official title: The Effects of Testosterone and Nutritional Supplementation, Alone and Combined, on the Adverse Effects of Under-Nutrition in the Elderly

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.

Read the detailed description

We hypothesize that oral androgen therapy and nutritional supplementation will have additive beneficial effects in older malnourished individuals living in the community; there will be a reduction in hospitalizations, falls and weight loss in association with improvements in functional measures and increases in lean body mass. The present study is designed to examine the effect of 12 months oral nutrition supplementation and androgen therapy, alone and combined, on (i) frequency and length of hospitalisations; (ii) functional status; (iii) body composition and weight; (iv) living arrangements; (v) death rate, in community dwelling under-nourished men and women, 65 years and older.

Conditions
Malnutrition, Aging
Being tested
testosterone undecanoate
Keywords
testosterone, food, formulated, malnutrition, undernutrition, aging, aged, aged, 80 and over, frail elderly
Medical subject headings
Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • testosterone undecanoateDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Days in hospital

  2. SF-36 quality of life scores (composite physical component score and composite mental component score).

Secondary outcomes (5)

  1. Body composition

  2. Muscle strength

  3. Number of falls

  4. Functional status (living arrangements, activities of daily living and frailty scale scores)

  5. Mortality

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2005 (estimated)
  2. Study startJul 2003
  3. Study completionFeb 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Enrolment
200 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00117000
Sponsor's protocol ID
030320
Status last verified
Sep 2006
First submitted
30 Jun 2005
Last updated
11 Sep 2006
Results posted
No

Publications

  • 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.

    PubMed 8429405

  • 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.

    PubMed 10332563

  • 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.

    PubMed 10202377

  • Volpi E, Sheffield-Moore M, Rasmussen BB, Wolfe RR. Basal muscle amino acid kinetics and protein synthesis in healthy young and older men. JAMA. 2001 Sep 12;286(10):1206-12. doi: 10.1001/jama.286.10.1206.

    PubMed 11559266

  • 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.

    PubMed 11890489

  • 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.

    PubMed 11054605

  • Morley JE. Anorexia in older persons: epidemiology and optimal treatment. Drugs Aging. 1996 Feb;8(2):134-55. doi: 10.2165/00002512-199608020-00007.

    PubMed 8845587

  • 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.

    PubMed 12834523

  • Morley JE. Testosterone replacement and the physiologic aspects of aging in men. Mayo Clin Proc. 2000 Jan;75 Suppl:S83-7.

    PubMed 10959223

  • Melton LJ 3rd, Khosla S, Riggs BL. Epidemiology of sarcopenia. Mayo Clin Proc. 2000 Jan;75 Suppl:S10-2; discussion S12-3.

    PubMed 10959209

  • 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.

    PubMed 9589646

  • 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.

    PubMed 10372681

  • 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.

    PubMed 7714119

  • 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.

    PubMed 10946891

  • Morley JE. Testosterone replacement in older men and women. J Gend Specif Med. 2001;4(2):49-53.

    PubMed 11480098

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing testosterone undecanoate in people with Malnutrition and Aging, run by University of Adelaide at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Days in hospital. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00117000, which also lists 70 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2006.

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