SarcopeniaPhase 3NCT03054168
Systemic Hormones and Muscle Protein Synthesis
A Phase 3 study testing Sustanon 250 and Zoladex in people with Sarcopenia and Muscle Hypotrophy, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
This study evaluates the effect of increase in testosterone levels in older males and the effects of decrease in testosterone levels in young males on muscle protein synthesis. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Muscle Hypotrophy, Muscle Atrophy
- What is being tested?
- Sustanon 250 and Zoladex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Dec 2016to 15 Feb 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Young (18-30y) and old (60-75y) males who are generally healthy
Who cannot join
- Participation in a formal exercise regime
- BMI < 18 or > 30 kg·m2
- Active cardiovascular disease:
- uncontrolled hypertension (BP > 160/100),
- angina,
- heart failure (class III/IV),
Show all 31Show fewer
- arrhythmia,
- right to left cardiac shunt,
- recent cardiac event
- Taking beta-adrenergic blocking agents, statins, non-steroidal anti-inflammatory drugs or HRT
- Cerebrovascular disease:
- previous stroke,
- aneurysm (large vessel or intracranial)
- epilepsy
- Respiratory disease including:
- pulmonary hypertension,
- COPD,
- asthma,
- Metabolic disease:
- hyper and hypo parathyroidism,
- Hypo and hyper gonadism
- untreated hyper and hypothyroidism,
- Cushing's disease,
- type 1 or 2 diabetes
- Active inflammatory bowel or renal disease
- Malignancy
- Altered hormonal profile
- Recent steroid treatment (within 6 months) or hormone replacement therapy
- Clotting dysfunction
- Musculoskeletal or neurological disorders
- Family history of early (<55y) death from cardiovascular disease
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Derby Hospital Medical School
Derby, Derbyshire, DE22 3DT
About this study
Official title: The Regulation of Skeletal Muscle Protein Synthesis by Systemic Hormones and Its Influence on Ageing and Anabolic Resistance
This study evaluates the effect of increase in testosterone levels in older males and the effects of decrease in testosterone levels in young males on muscle protein synthesis.
Read the detailed description
Skeletal muscle represents the largest organ in the body, comprising >50% of total body mass. The function of skeletal muscle is best understood for its role in locomotion and providing mechanical support to the skeleton to facilitate movement. However, skeletal muscles are also important for maintaining whole-body metabolic health. For example, muscles also act as a site for glucose disposal thereby acting to maintain whole-body glycaemic control. In addition, skeletal muscles represent a vast protein store, the amino acids from which can be used in times of fasting, infection and disease to provide energy to maintain other critical organs. Exercise (resistance type exercise (RE-T) in particular) still remains the most effective means by which to maintain and increase muscle mass through stimulation of muscle protein synthesis (MPS), despite this, how exercise regulates these changes in muscle mass is still unknown. A number of pathways have been inferred as key, however it is clear from a number of studies that systemic hormone levels, testosterone in particular, may provide a significant contribution. It is well known that chronic androgenic hormone deficiency can lead to a loss of lean body mass and strength, which can in turn contribute to impaired physical function. Furthermore, when testosterone levels are pharmacologically reduced (using a gonadotropin releasing hormone analogue) in healthy young males, resistance exercise training induced increases in muscle mass and strength are absent. Whilst systemic hormone levels are carefully maintained in youth (unless illness or deficiency is present), levels of these hormones decrease with age, particularly in those that are not regularly physically active, indeed approximately 25-30% of older men have levels of testosterone which are below the threshold used to define hypogonadism. Therefore, there is significant need to understand the underlying mechanisms behind hormonally induced muscle mass regulation. Furthermore, in older age there is a resistance to traditional anabolic stimuli such as nutrition or resistance exercise, with older adults showing a blunted-anabolic hormonal profile in response to resistance training compared to young. These impairments to hormonal regulation with ageing may in part be responsible for the slow decline in muscle mass with age known as sarcopenia. Whilst all muscle-wasting conditions are of considerable concern, it is the loss of muscle in older age that poses the greatest socio-economic burden. Therefore there is a significant clinical need to identify contributing factors to this muscle loss so that they can be specifically targeted for intervention (i.e., pharmacological hormonal therapies).
The aims of this project are two fold: 1) Firstly we aim to investigate the impact of systemic hormone levels on control of muscle mass in healthy young adults undertaking a resistance exercise training program, we hypothesize that reduction of hormone levels in systemically normal young adults will impair MPS and muscle mass gains in response to resistance exercise training. 2) Secondly we aim to investigate the impact of enhancing testosterone levels in older adults on responsiveness to resistance exercise training and the contribution of systemic testosterone levels to muscle mass regulation in ageing, we hypothesize that increasing testosterone levels in older males will improve responsiveness to anabolic stimuli (RE-T).
- Conditions
- Sarcopenia, Muscle Hypotrophy, Muscle Atrophy
- Being tested
- Sustanon 250, Zoladex, Placebo
- Keywords
- Protein Synthesis, Hypertrophy, Testosterone
- Medical subject headings
- Sarcopenia, Muscular Atrophy, Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustanon 250Drug
Also called Testosterone
The frequency of the injection will be every 2 weeks, 250mg of testosterone, intramuscular injection.
ZoladexDrug
Also called Gonadotropin-releasing hormone analogue; Goserelin
The frequency of the injection will be just one injection, 3.6 mg of Zoladex, Subcutaneous injection (abdomen).
PlaceboOther
Also called Saline
| Study group | Role | What they receive |
|---|---|---|
| Old Testosterone trained | Experimental | 8 old participants (65-75 years old) who will receive resistance exercise training and Testosterone (Sustanon 250: 250 mg every 2wks)
Drug name: Sustanon 250 Generic Name: Testosterone Proprietary Name: N/A Formulation: 250mg of Testosterone in 1ml volume Dose: 250mg of testosterone Frequency: every 2 weeks Route: intramuscular injection Receives: Drug: Sustanon 250 |
| Old Placebo trained | Placebo comparator | 8 old participants (65-75 years old) who will receive resistance exercise training and Placebo every two weeks. Receives: Other: Placebo |
| Young Zoladex trained | Experimental | 8 young participants (18-30 years old) who will receive resistance exercise training and Testosterone inhibitor (3.6mg Zoladex subcutaneous injection, one time over the study)
Drug name: Zoladex Generic Name: Gonadotropin-releasing hormone analogue; Goserelin Proprietary Name: N/A Formulation: Solution for injection Dose: 3.6mg Frequency: Single injection one time over the study. Route: Subcutaneous injection (abdomen) performed by clinician. Receives: Drug: Zoladex |
| Young placebo trained | Placebo comparator | 8 young participants (18-30 years old) who will receive resistance exercise training and placebo, one time over the study. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Protein Synthesis
Comparison of muscle protein synthesis between young and older individuals when their testosterone levels decrease and increase, respectively; in response to 6 weeks whole body resistance exercise training
Measured: 0-6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start15 Dec 2016
- Primary completion15 Nov 2018
- Study completion15 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To achieve our aims we will recruit 16 young healthy males (Age: 18-30 y; BMI: 18-30kg/m2) and 16 older healthy males (Age: 65-75 y; BMI: 18-30kg/m2). Volunteers will then be randomly assigned to a testing group; 1) Young placebo trained (N=10), 2) Young gonadotropin releasing hormone analogue trained (3.6mg Zoladex subcutaneous injection (every 4 weeks) N=10), 3) Old placebo trained (N=10) and 4) Old Testosterone trained (Sustanon 250: 250 mg every 2-3wks intramuscular injection, N=10). All participants will receive whole body resistance exercise training for six weeks.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Atherton, University of Nottingham
- Investigators
- Philip J Atherton, Professor, Principal investigator, The University of NottinghamNathaniel Szewczyk, Ass. Proff, Study chair, The University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054168
- Sponsor's protocol ID
- Hormones
- Status last verified
- Feb 2019
- First submitted
- 10 Feb 2017
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mauras N, Hayes V, Welch S, Rini A, Helgeson K, Dokler M, Veldhuis JD, Urban RJ. Testosterone deficiency in young men: marked alterations in whole body protein kinetics, strength, and adiposity. J Clin Endocrinol Metab. 1998 Jun;83(6):1886-92. doi: 10.1210/jcem.83.6.4892.
PubMed 9626114Kvorning T, Andersen M, Brixen K, Madsen K. Suppression of endogenous testosterone production attenuates the response to strength training: a randomized, placebo-controlled, and blinded intervention study. Am J Physiol Endocrinol Metab. 2006 Dec;291(6):E1325-32. doi: 10.1152/ajpendo.00143.2006. Epub 2006 Jul 25.
PubMed 16868226Abbasi AA, Drinka PJ, Mattson DE, Rudman D. Low circulating levels of insulin-like growth factors and testosterone in chronically institutionalized elderly men. J Am Geriatr Soc. 1993 Sep;41(9):975-82. doi: 10.1111/j.1532-5415.1993.tb06764.x.
PubMed 8409184Harman SM, Metter EJ, Tobin JD, Pearson J, Blackman MR; Baltimore Longitudinal Study of Aging. Longitudinal effects of aging on serum total and free testosterone levels in healthy men. Baltimore Longitudinal Study of Aging. J Clin Endocrinol Metab. 2001 Feb;86(2):724-31. doi: 10.1210/jcem.86.2.7219.
PubMed 11158037Baker JR, Bemben MG, Anderson MA, Bemben DA. Effects of age on testosterone responses to resistance exercise and musculoskeletal variables in men. J Strength Cond Res. 2006 Nov;20(4):874-81. doi: 10.1519/R-18885.1.
PubMed 17194250Kumar V, Selby A, Rankin D, Patel R, Atherton P, Hildebrandt W, Williams J, Smith K, Seynnes O, Hiscock N, Rennie MJ. Age-related differences in the dose-response relationship of muscle protein synthesis to resistance exercise in young and old men. J Physiol. 2009 Jan 15;587(1):211-7. doi: 10.1113/jphysiol.2008.164483. Epub 2008 Nov 10.
PubMed 19001042Vingren JL, Kraemer WJ, Ratamess NA, Anderson JM, Volek JS, Maresh CM. Testosterone physiology in resistance exercise and training: the up-stream regulatory elements. Sports Med. 2010 Dec 1;40(12):1037-53. doi: 10.2165/11536910-000000000-00000.
PubMed 21058750
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Regulation of Skeletal Muscle Protein Synthesis by Systemic Hormones and Its Influence on Ageing and Anabolic Resistance
- ClinicalTrials.gov ID
- NCT03054168
- Acronym / sponsor ID
- Hormones
- Conditions
- Sarcopenia, Muscle Hypotrophy, Muscle Atrophy
- Keywords
- Protein Synthesis, Hypertrophy, Testosterone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 15 Feb 2019 (estimated)
- First posted
- 15 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effect of increase in testosterone levels in older males and the effects of decrease in testosterone levels in young males on muscle protein synthesis.
Detailed description
Skeletal muscle represents the largest organ in the body, comprising >50% of total body mass. The function of skeletal muscle is best understood for its role in locomotion and providing mechanical support to the skeleton to facilitate movement. However, skeletal muscles are also important for maintaining whole-body metabolic health. For example, muscles also act as a site for glucose disposal thereby acting to maintain whole-body glycaemic control. In addition, skeletal muscles represent a vast protein store, the amino acids from which can be used in times of fasting, infection and disease to provide energy to maintain other critical organs. Exercise (resistance type exercise (RE-T) in particular) still remains the most effective means by which to maintain and increase muscle mass through stimulation of muscle protein synthesis (MPS), despite this, how exercise regulates these changes in muscle mass is still unknown. A number of pathways have been inferred as key, however it is clear from a number of studies that systemic hormone levels, testosterone in particular, may provide a significant contribution. It is well known that chronic androgenic hormone deficiency can lead to a loss of lean body mass and strength, which can in turn contribute to impaired physical function. Furthermore, when testosterone levels are pharmacologically reduced (using a gonadotropin releasing hormone analogue) in healthy young males, resistance exercise training induced increases in muscle mass and strength are absent. Whilst systemic hormone levels are carefully maintained in youth (unless illness or deficiency is present), levels of these hormones decrease with age, particularly in those that are not regularly physically active, indeed approximately 25-30% of older men have levels of testosterone which are below the threshold used to define hypogonadism. Therefore, there is significant need to understand the underlying mechanisms behind hormonally induced muscle mass regulation. Furthermore, in older age there is a resistance to traditional anabolic stimuli such as nutrition or resistance exercise, with older adults showing a blunted-anabolic hormonal profile in response to resistance training compared to young. These impairments to hormonal regulation with ageing may in part be responsible for the slow decline in muscle mass with age known as sarcopenia. Whilst all muscle-wasting conditions are of considerable concern, it is the loss of muscle in older age that poses the greatest socio-economic burden. Therefore there is a significant clinical need to identify contributing factors to this muscle loss so that they can be specifically targeted for intervention (i.e., pharmacological hormonal therapies).
The aims of this project are two fold: 1) Firstly we aim to investigate the impact of systemic hormone levels on control of muscle mass in healthy young adults undertaking a resistance exercise training program, we hypothesize that reduction of hormone levels in systemically normal young adults will impair MPS and muscle mass gains in response to resistance exercise training. 2) Secondly we aim to investigate the impact of enhancing testosterone levels in older adults on responsiveness to resistance exercise training and the contribution of systemic testosterone levels to muscle mass regulation in ageing, we hypothesize that increasing testosterone levels in older males will improve responsiveness to anabolic stimuli (RE-T).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- To achieve our aims we will recruit 16 young healthy males (Age: 18-30 y; BMI: 18-30kg/m2) and 16 older healthy males (Age: 65-75 y; BMI: 18-30kg/m2). Volunteers will then be randomly assigned to a testing group; 1) Young placebo trained (N=10), 2) Young gonadotropin releasing hormone analogue trained (3.6mg Zoladex subcutaneous injection (every 4 weeks) N=10), 3) Old placebo trained (N=10) and 4) Old Testosterone trained (Sustanon 250: 250 mg every 2-3wks intramuscular injection, N=10). All participants will receive whole body resistance exercise training for six weeks.
| Arm | Type | Receives |
|---|---|---|
| Old Testosterone trained | Experimental | Drug: Sustanon 2508 old participants (65-75 years old) who will receive resistance exercise training and Testosterone (Sustanon 250: 250 mg every 2wks) Drug name: Sustanon 250 Generic Name: Testosterone Proprietary Name: N/A Formulation: 250mg of Testosterone in 1ml volume Dose: 250mg of testosterone Frequency: every 2 weeks Route: intramuscular injection |
| Old Placebo trained | Placebo comparator | Other: Placebo8 old participants (65-75 years old) who will receive resistance exercise training and Placebo every two weeks. |
| Young Zoladex trained | Experimental | Drug: Zoladex8 young participants (18-30 years old) who will receive resistance exercise training and Testosterone inhibitor (3.6mg Zoladex subcutaneous injection, one time over the study) Drug name: Zoladex Generic Name: Gonadotropin-releasing hormone analogue; Goserelin Proprietary Name: N/A Formulation: Solution for injection Dose: 3.6mg Frequency: Single injection one time over the study. Route: Subcutaneous injection (abdomen) performed by clinician. |
| Young placebo trained | Placebo comparator | Other: Placebo8 young participants (18-30 years old) who will receive resistance exercise training and placebo, one time over the study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Young (18-30y) and old (60-75y) males who are generally healthy
Key exclusion criteria (31 listed)
- Participation in a formal exercise regime
- BMI < 18 or > 30 kg·m2
- Active cardiovascular disease:
- Taking beta-adrenergic blocking agents, statins, non-steroidal anti-inflammatory drugs or HRT
- Cerebrovascular disease:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sustanon 250Also: TestosteroneThe frequency of the injection will be every 2 weeks, 250mg of testosterone, intramuscular injection. | Drug | Old Testosterone trained |
| ZoladexAlso: Gonadotropin-releasing hormone analogue; GoserelinThe frequency of the injection will be just one injection, 3.6 mg of Zoladex, Subcutaneous injection (abdomen). | Drug | Young Zoladex trained |
| PlaceboAlso: Saline | Other | Old Placebo trained, Young placebo trained |
Primary outcome
Muscle Protein Synthesis
Time frame: 0-6 Weeks
Comparison of muscle protein synthesis between young and older individuals when their testosterone levels decrease and increase, respectively; in response to 6 weeks whole body resistance exercise training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Background: PubMed 9626114Mauras N, Hayes V, Welch S, Rini A, Helgeson K, Dokler M, Veldhuis JD, Urban RJ. Testosterone deficiency in young men: marked alterations in whole body protein kinetics, strength, and adiposity. J Clin Endocrinol Metab. 1998 Jun;83(6):1886-92. doi: 10.1210/jcem.83.6.4892.
- Background: PubMed 16868226Kvorning T, Andersen M, Brixen K, Madsen K. Suppression of endogenous testosterone production attenuates the response to strength training: a randomized, placebo-controlled, and blinded intervention study. Am J Physiol Endocrinol Metab. 2006 Dec;291(6):E1325-32. doi: 10.1152/ajpendo.00143.2006. Epub 2006 Jul 25.
- Background: PubMed 8409184Abbasi AA, Drinka PJ, Mattson DE, Rudman D. Low circulating levels of insulin-like growth factors and testosterone in chronically institutionalized elderly men. J Am Geriatr Soc. 1993 Sep;41(9):975-82. doi: 10.1111/j.1532-5415.1993.tb06764.x.
- Background: PubMed 11158037Harman SM, Metter EJ, Tobin JD, Pearson J, Blackman MR; Baltimore Longitudinal Study of Aging. Longitudinal effects of aging on serum total and free testosterone levels in healthy men. Baltimore Longitudinal Study of Aging. J Clin Endocrinol Metab. 2001 Feb;86(2):724-31. doi: 10.1210/jcem.86.2.7219.
- Background: PubMed 17194250Baker JR, Bemben MG, Anderson MA, Bemben DA. Effects of age on testosterone responses to resistance exercise and musculoskeletal variables in men. J Strength Cond Res. 2006 Nov;20(4):874-81. doi: 10.1519/R-18885.1.
- Background: PubMed 19001042Kumar V, Selby A, Rankin D, Patel R, Atherton P, Hildebrandt W, Williams J, Smith K, Seynnes O, Hiscock N, Rennie MJ. Age-related differences in the dose-response relationship of muscle protein synthesis to resistance exercise in young and old men. J Physiol. 2009 Jan 15;587(1):211-7. doi: 10.1113/jphysiol.2008.164483. Epub 2008 Nov 10.
- Background: PubMed 21058750Vingren JL, Kraemer WJ, Ratamess NA, Anderson JM, Volek JS, Maresh CM. Testosterone physiology in resistance exercise and training: the up-stream regulatory elements. Sports Med. 2010 Dec 1;40(12):1037-53. doi: 10.2165/11536910-000000000-00000.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip J Atherton, Professor principal investigator
The University of Nottingham
Nathaniel Szewczyk, Ass. Proff study chair
The University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sustanon 250 and Zoladex in people with Sarcopenia and Muscle Hypotrophy, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Protein Synthesis (time frame: 0-6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03054168, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019; AzTrials last refreshed its copy on 26 Oct 2026.