Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone?

• Status: Not yet recruiting
• Trial end date: 2025-07-30
• Target enrollment: 0
• Participant gender: Male

Summary

This project's primary aim of this double-blinded, randomised, placebo-controlled trial is to investigate whether short-term testosterone administration +/- resistance exercise training induces a muscle memory response that can lead to longer-lasting benefits in aged human skeletal muscle.

The investigators will provide older men with the anabolic hormone, testosterone or placebo, with or without resistance training, followed by a period of testosterone abstinence and detraining, followed by a subsequent repeated period of resistance training (retraining). This will help determine if earlier encounters with short-term testosterone administration can be "remembered" and if adaptation to later retraining can be enhanced as a consequence of encountering testosterone earlier.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Norwegian School of Sport Sciences
• Collaborator: Oslo University Hospital
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

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