A Pilot Study on Reverse Aging (The REVERSE Study)

The Christ Hospital

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Aging

Treatments: Dietary Supplement: Prolon diet; Drug: Rapamycin (Tablets)

Study type: Interventional

Funder types: Other

Identifiers

NCT07354620

24-088

Details and patient eligibility

About

Aging can be defined as a time-dependent functional decline in physiological function, which may increase the vulnerability to diseases and eventually death. The question is whether aging is a normal process, or exists as an "uber-illness?" Work done by Dr Sinclair at Harvard suggests the latter. Dr. Sinclair feels people should be able to age-in-place, or even reverse age. Aging is arguably the single biggest risk factor for all acquired and chronic diseases. Delaying the aging rate by 7 years would cut the incidence of chronic disease in half! Up until know the effects of anti-aging would need longitudinal studies until death.

Now, with the advent of a 3rd generation OMIC Age clock, there is a way to assess if an intervention is changing the rate of aging and other methylation patterns associated with aging.

Enrollment: 52 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects will be healthy and of any sex, any ethnicity, and any age from 50 to 80
• "Healthy" subjects will be defined as a real-world cohort of individuals likely to utilize such an intervention
• May be on other medications if they do not conflict with rapamycin.
• All medical conditions need to be stable and well controlled.
• Willing and able to provide informed consent

Exclusion criteria

• Severe illnesses, for which rapamycin may cause harm. This would not be limited to but include active neoplastic or auto-immune disease. If patients have a previous history of cancer or auto-immune disease, the risks and benefits and possible adverse reactions will be discussed at time of consent
• History of organ transplant
• Any unstable medical condition that would interfere with the study
• Hepatic impairment. Note: Patients with elevated liver enzymes and low albumin, will be further screened for hepatic impairment. Elevated liver enzymes < 2x upper limit of normal will not be considered hepatic impairment.
• Renal impairment, indicated by a serum creatinine > 1.4 mg/dL
• Anemia indicated by a hemoglobin < 12 g/dL
• Platelets < 80,000/cumm,
• ANC < 1,000 / cumm
• Total WBC < 3,000/cumm
• Pregnancy or breastfeeding or woman of childbearing potential with inadequate contraception
• Unstable mental illness
• A condition where rapamycin may interfere deleteriously with a medication that is taken by a potential subject
• Currently prescribed with high dose CYP3A4 pathway medications such as verapamil > 240 mg; simvastatin >40 mg, lovastatin > 40 mg or atorvastatin > 40 mg daily. Poor GI motility as demonstrated by delayed gastric emptying on a radionucleotide isotope scan.
• Intercurrent severe infection at initiation of study drug
• Any and all other reasons that the investigator may determine that the participant is not suitable for study enrollment.
• History of or active eating disorders as deemed by PI.
• BMI lower than 18.5
• Any medication that may dangerously lower glucose while on the FMD. This will include insulin, sulfonylureas (glyburide; glipizide); Thiazolidenediones ( eg piogltazone; rosiglitazone); GLP1 drugs (semaglutide; tirzepatide);; DPP-4 inhibitors (eg sitagliptin; saxagliptin); Alpha -glucosidase inhibitors (acarbose; miglitol). Patients on SGLT2 inhibitors (empagliflozin; canagliflozin) and Metformin (glucophage) may be included in the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 3 patient groups

Rapamycin Only

Experimental group

Description:

12 participants: 10 mg initial bolus dose of rapamycin followed by a weekly 6 mg rapamycin, enrolling 6 men, 6 women, with 6 ( 3 M, 3 F) who are 50-65 years; 6 ( 3 M, 3 F) who are \>65 years

Treatment:

Drug: Rapamycin (Tablets)

Prolon Diet Only

Active Comparator group

Description:

12 participants: 6 men, 6 women, with 6 (3 M, 3 F) who are 50-65 years; 6 who are \>65 years Prolon® 5-day diet at 0, 1, 2, 3, 4 and 5 months;

Treatment:

Dietary Supplement: Prolon diet

Rapamycin and Prolon Diet

Experimental group

Description:

24 participants: 10 mg initial bolus dose of rapamycin followed by a weekly 6 mg rapamycin along with Prolon 5-day diet at 0, 1, 2, 3, 4,and 5 months. : 12 men, 12 women, 12 ( 6 M, 6 F) who are 50-65 years; 12 ( 6 M, 6 F) who are \>65 years.

Treatment:

Dietary Supplement: Prolon diet

Drug: Rapamycin (Tablets)