Investigating if testosterone can create lasting muscle benefits in older men
Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone?
This study is testing if short-term testosterone treatment can help older men build stronger muscles that last even after they stop exercising.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 55 Years to 70 Years |
| Sex | Male |
| Sponsor | Norwegian School of Sport Sciences Academic / other |
| Locations | 1 site (Oslo) |
| Trial ID | NCT05964920 on ClinicalTrials.gov |
What this trial studies
This double-blinded, randomized, placebo-controlled trial aims to explore whether short-term testosterone administration, with or without resistance exercise training, can induce a muscle memory response in older men. Participants aged 55-70 will receive either testosterone or a placebo, followed by a period of abstinence and detraining, and then a retraining phase. The study will assess if prior exposure to testosterone enhances the muscle's adaptation to subsequent resistance training. This approach seeks to understand the potential long-term benefits of testosterone on muscle health in aging individuals.
Who should consider this trial
Good fit: Ideal candidates are sedentary males aged 55-70 with normal testosterone levels and no significant health issues.
Not a fit: Patients with active cardiovascular disease, malignancies, or those currently engaged in formal exercise programs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for preventing age-related muscle loss and enhancing physical function in older men.
How similar studies have performed: While the concept of muscle memory in response to testosterone is being explored, this specific approach combining short-term testosterone with resistance training in older men is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Sedentary males * 55-70 years old * Serum testosterone levels \>8 nmol/L measured in the morning * Without any known illness, disease or other conditions * Undergone screening through medical questionnaire, physical examination, routine blood tests and urine sample * Written informed consent received Exclusion Criteria: * Current or previous participation in a formal exercise regime * A BMI \< 18 or \> 30 kg·m2 * Hypersensitivity to the study drug or to any of its constituents * Active cardiovascular disease: uncontrolled hypertension (BP \> 160/100 mmHg), angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt, recent cardiac event * Family history of early (\<55y) death from cardiovascular disease * Haematocrit \>50% * Malignancy * Prostate-specific antigen (PSA) \>4 ng/mL * Lower urinary tract symptoms * Taking beta-adrenergic blocking agents, statins, non-steroidal anti-inflammatory drugs * Cerebrovascular disease: previous stroke, aneurysm (large vessel or intracranial), epilepsy * Respiratory diseases including: pulmonary hypertension, chronic obstructive pulmanary disease (COPD), asthma, sleep apnoea * Metabolic disease: hyper and hypo parathyroidism, untreated hyper and hypothyroidism, Cushing's disease, type 1 or 2 diabetes * Active inflammatory bowel or renal disease * Current or previous steroid treatment or hormone replacement therapy * Clotting dysfunction * Musculoskeletal or neurological disorders * Alcohol or drug abuse * Receiving oral anticoagulants * Serum testosterone levels above the reference range for 50 year olds (\>32 nmol/L) (Bjerner et al., 2009) measured in the morning 1
Where this trial is running
Oslo
- Norwegian School of Sport Sciences — Oslo, Norway (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.