Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Aging Age-Related Sarcopenia Testosterone Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

The placebo group will complete 10-week treatment period where they continue with their regular habitual daily physical activity and receive two placebo (saline) injections (at baseline and week 3). They will then undergo a 12-week period with no treatment and no training, where they just do their regular habitual daily physical activity. Before they undertake a period of structured, progressive resistance training for 10-weeks.

Questionnaires, physiological and psychological measures, skeletal muscle biopsies and blood samples will be taken at time points of:

1. Baseline (week 0)
2. Treatment period (week 10)
3. Detraining and placebo abstinence (week 22)
4. Retraining (week 32)

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Two placebo injections one at baseline and one week 3.

Testosterone Undecanoate

The testosterone group will complete 10-week treatment period where they continue with their regular habitual daily physical activity and receive two testosterone undecanoate (Nebido) injections (1000 mg/4 ml at baseline and 500 mg/2 ml week 3). They will then undergo a 12-week period with no treatment and no training, where they just do their regular habitual daily physical activity. Before they undertake a period of structured, progressive resistance training for 10-weeks.

Questionnaires, physiological and psychological measures, skeletal muscle biopsies and blood samples will be taken at time points of:

1. Baseline (week 0)
2. Treatment period (week 10)
3. Detraining and testosterone abstinence (week 22)
4. Retraining (week 32)

Group Type EXPERIMENTAL

Testosterone Undecanoate

Intervention Type DRUG

Two testosterone undecanoate injections, 1000 mg/4 ml at baseline, 500 mg/2 ml at week 3.

Resistance exercise training + Placebo

The resistance exercise training + placebo group will complete 10-week treatment period where they undergo a period of structured, progressive resistance training and receive two placebo (saline) injections (at baseline and week 3). They will then undergo a 12-week period with no treatment and no training, where they return to their regular habitual daily physical activity. Before they undertake a second period of structured, progressive resistance training for 10-weeks.

Questionnaires, physiological and psychological measures, skeletal muscle biopsies and blood samples will be taken at time points of:

1. Baseline (week 0)
2. Treatment period (week 10)
3. Detraining and placebo abstinence (week 22)
4. Retraining (week 32)

Group Type PLACEBO_COMPARATOR

Saline + Resistance exercise training

Intervention Type DRUG

Two placebo injections one at baseline and one week 3 and10 weeks of supervised, structured, progressive resistance training.

Resistance exercise training + Testosterone Undecanoate

The resistance exercise training + testosterone group will complete 10-week treatment period where they undergo a period of structured, progressive resistance training and receive two testosterone undecanoate (Nebido) injections (1000 mg/4 ml at baseline and 500 mg/2 ml week 3). They will then undergo a 12-week period with no treatment and no training, where they return to their regular habitual daily physical activity. Before they undertake a second period of structured, progressive resistance training for 10-weeks.

Questionnaires, physiological and psychological measures, skeletal muscle biopsies and blood samples will be taken at time points of:

1. Baseline (week 0)
2. Treatment period (week 10)
3. Detraining and testosterone abstinence (week 22)
4. Retraining (week 32)

Group Type EXPERIMENTAL

Testosterone Undecanoate + Resistance exercise training

Intervention Type DRUG

Two testosterone undecanoate injections, 1000 mg/4 ml at baseline, 500 mg/2 ml at week 3 and 10 weeks of supervised, structured, progressive resistance training.

Interventions

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Saline

Two placebo injections one at baseline and one week 3.

Intervention Type DRUG

Testosterone Undecanoate

Two testosterone undecanoate injections, 1000 mg/4 ml at baseline, 500 mg/2 ml at week 3.

Intervention Type DRUG

Saline + Resistance exercise training

Two placebo injections one at baseline and one week 3 and10 weeks of supervised, structured, progressive resistance training.

Intervention Type DRUG

Testosterone Undecanoate + Resistance exercise training

Two testosterone undecanoate injections, 1000 mg/4 ml at baseline, 500 mg/2 ml at week 3 and 10 weeks of supervised, structured, progressive resistance training.

Intervention Type DRUG

Other Intervention Names

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Placebo Nebido, Grünenthal (Grünenthal Norway AS) Placebo + Resistance exercise training Nebido, Grünenthal (Grünenthal Norway AS) + Resistance exercise training

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes