CompletedPhase 2/3

Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone?

Norway45 participantsStarted 2024-09-01

Plain-language 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.

Who can participate

Age range55 Years – 70 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

What they're measuring

Fat-free mass

Timeframe: Baseline and weeks 10, 22, 32

Skeletal muscle size and cross-sectional area (CSA)

Timeframe: Baseline and week 5,10, 16, 22, 27, 32

Skeletal muscle fibre CSA

Timeframe: Baseline and weeks 10, 22, 32

Trial details

NCT IDNCT05964920

SponsorNorwegian School of Sport Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-22