Rapamycin impact on muscle strength and endurance in older adults

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

1.Male or female aged between 65 years and 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 or taking antibiotics or antifungal medications.
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.Prescribed substances that inhibit or induce CYP3A4 and/or P-glycoprotein (P-gp)
11.Current prescribed or reported cannabinoid use
12.COPD Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification III or IV
13.Impaired renal function, as defined as glomerular filtration rate eGFR < 30
14.Type 1 diabetes or uncontrolled Type 2 Diabetes (defined as HbA1c = 60 mmol/mol)
15.Metformin, Rapamycin, or rapalogs use within 6 months prior to baseline.
16.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.
17.Any form of clinically relevant primary or secondary immune dysfunction or deficiency (e.g. X-linked agammaglobulinemia (XLA), common variable immunodeficiency (CVID))
18.Chronic oral corticosteroid or immunosuppressive medication use (e.g. Enbrel, Humira, methotrexate, ciclosporin).
19.Participation in any other study (for 30 days) prior to or during this study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the effect of Rapamycin on muscle strength and endurance in an older population following an exercise program.<br>- This is a composite primary outcome of muscle strength and endurance. [The difference in the 30-Second Chair-Stand Test between the placebo arm vs Rapamycin arm participants (comparison of arns). Measured at Baseline, Day 42 (+/-7), Day 91 (+7, primary endpoint)]

Secondary Outcome Measures