None listed
Conditions
Brief summary
Our brief hypothesis is that low-dose Rapamycin, in combination with exercise, will result in greater muscle strength than exercise alone. The purpose of this study is to: • Evaluate changes in muscle strength and endurance following weekly low dose Rapamycin treatment in combination with an exercise programme. • Evaluate whether low dose Rapamycin treatment is safe and well tolerated in an older population. Rapamycin works by blocking the mTOR cell signalling pathway. When mTOR is over activated, it can lead to muscle wasting and ageing. It is believed that Rapamycin may help balance mTOR signalling and thereby improve muscle strength, muscle growth and exercise performance in older adults.
Interventions
The study evaluates the change in muscle performance, as measured by the 30-Second Chair-Stand Test (30CST), following a 13-week exercise regimen combined with weekly dosing of Rapamycin, compared to placebo and exercise.
The assessment will establish whether weekly administration of Rapamycin, which inhibits the mechanistic target of the Rapamycin (mTORC1) pathway, impacts the beneficial effects of exercise on muscle performance.
Sponsors
Dr Brad Stanfield Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
65 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female aged 65 years to 85 years at the time of signing informed consent 2. BMI between 18 and 40 and a maximum weight of 120kg at screening. 3. Currently sedentary lifestyle or performing moderate exercise for less than 15 mins, 3 times a week 4. Capable of providing written informed consent 5. Willing to swallow a #000 sized capsule 6. Willing and able to adhere to and comply with all study requirements, and attend all study visits 7. Able to complete the 30 second Chair Stand Test utilising correct technique 8. Is able to accommodate and use an exercycle at home for the duration of study participation
Exclusion criteria
1. Anaemia - Hg < 9.0 g/dl, Leukopenia - white blood cells (WBC) < 3,500/mm3, Neutropenia - absolute neutrophil count < 2,000/mm3 , or Platelet count - platelet count < 125,000/mm3 2. Planned surgery during the period of the study that is likely to impact on ability to perform required study exercises 3. Any medical or psychological condition which in the opinion of the investigator, may interfere with the participants ability to and comply with the study requirements and/or put the participant at significant risk. 4. Impaired wound healing or history of a chronic open wound. 5. Active infection at the time of signing consent. 6. Malignancy (except non-melanoma skin cancers, cervical carcinoma in-situ) within the last 5 years. 7. Known hypersensitivity, allergy, or any contraindication to Rapamycin or placebo (cellulose powder) or its excipients 8. Fibromyalgia or Chronic Fatigue Syndrome/Myalgic Encephalomyelitis, Breast Implant Illness, or other conditions that impact the participants ability to perform the exercise program 9. Known congestive heart failure with New York Heart Association (NYHA) classification III or IV 10. COPD Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification III or IV 11. Impaired renal function, as defined as glomerular filtration rate eGFR < 30 12. Type 1 diabetes or uncontrolled Type 2 Diabetes (defined as HbA1c at least 60 mmol/mol) 13. Metformin, Rapamycin, or rapalogs use within 6 months prior to baseline. 14. Impaired hepatic function, measured by alkaline Phosphatase (ALP), alanine aminotransferase (ALT), Albumin, or T. Bili, whereby the levels are 1.5x greater than the normal upper limit. 15. Any form of clinically relevant primary or secondary immune dysfunction or deficiency (e.g. X-linked agammaglobulinemia (XLA), common variable immunodeficiency (CVID)) 16. Chronic oral corticosteroid or immunosuppressive medication use (e.g. Enbrel, Humira, methotrexate). 17. Participation in any other study (for 30 days) prior to or during this study.
Outcome results
None listed