None listed
Conditions
Brief summary
Weight loss and under-nutrition is common in older people and associated with poor outcomes. This includes increased rates of hospital admissions. In a pilot study of ndernourished older, community dwelling people we found that daily treatment for one year with a combination of testosterone tablets and a nutritional supplement produced a significant reduction in hospitalizations. We propose a larger, multicentre study to explore and hopefully confirm this exciting, potentially important finding.
Interventions
Nutritional liquid supplement 2 times per day (180 ml) for 12 months,
and oral capsule andriol testocaps (testosterone undecanoate) (40mg daily women, 80mg twice daily men) for 12 months.
The vanilla nutritional supplement delivers 70.97kJ/180 mls, 0.186g protein, 0.98 g fat and 35-45 g carbohydrate.
The chocolate nutritutional supplement delivers 95.48 kJ/180 mls, 0.186 g protein, and 0.98 g of fat.
Sponsors
University of Adelaide
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.Men and women aged 65 years or older who are under-nourished, as defined by Mini Nutritional Assessment (MNA) score 17-23.5 out of 30. AND 1 or more of A body mass index (BMI) of less than 22 kg/m2 Weight loss in the 3 months before enrolling in the study 2.Living independently in the community (not in a hospital, nursing home or hostel) 3.Understand and sign the informed consent document, able to communicate with the investigator, and understand and comply with the requirements of the study. 4.Women who are taking oestrogen or other hormone replacement therapy (HRT) may take part, 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.
Exclusion criteria
1.Elevated haematocrit (HCT) levels (>50%) 2.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]) 3.Men with a past/present or family history of male breast cancer 4.Women with a past/present history of breast cancer. 5.Pre-existing androgenic signs or symptoms in women of concern to either subject or investigator (deep voice, hirsutism, acne, androgenic hair loss). 6.Depression (Yesavage Geriatric Depression Scale (GDS) Score > 12) 7.Significant cardiac failure (New York Heart Association (NYHA) functional classification system Class III and above) 8.Abnormal liver function tests ( Alanine transaminase ALT, Gamma-glutamyltransferase GGT, bilirubin or alkaline phosphatase test ALP > 2x upper limit of normal) 9.Nephrotic syndrome; 24h urine protein > 3 grams (24h urine save performed if dipstick positive proteinuria at screening) AND/OR estimated/calculated creatinine clearance (by the equation of Baracskay and Jarkoura for ambulatory elderly subjects [Cr clearance = 4.4/serum creatinine (mmol/L) + (88-age)] < 30 ml/min AND/OR serum creatinine concentration > 0.2mmol/l. 10.Any disease, which in the opinion of the investigator is likely to lead to death within 1 year 11.Folstein’s Mini Mental State Examination [MMSE] score of < 23 12.Testosterone or other androgen therapy in the four months before starting the study.
Outcome results
None listed