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OpenTrials
Active, Not Recruiting

NCT Number: NCT07354620

A Pilot Study on Reverse Aging (The REVERSE Study)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Aging

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

AIM for Wellbeing

Cincinnati, Ohio, 45236, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rapamycin (Tablets)

Drug

10 mg initial bolus dose of rapamycin followed by a weekly 6 mg rapamycin

Prolon diet

Dietary Supplement

Prolon 5-day diet at 0, 1, 2, 3, 4,and 5 months

Primary outcomes

  1. Change in Biological Age from Baseline to End of Study based on Tru Diagnostic Tru Age OMICm Age test results.

    Time frame: 24 weeks

    To evaluate the gradated effects of mTOR inhibition on a new OMIC methylation test that evaluates biological (vs chronological) age over a six-month period.

Secondary outcomes

  1. To evaluate the effects of AMPK (AMP Kinase inhibition) on aging. Change in OMICm methylation from baseline to Week 24 based on Tru Diagnostic Tru Age OMICm Age test results.

    Time frame: 24 weeks

    . This will duplicate studies already done utilizing a 5 day Fasting Mimicking Diet (FMD) (Prolon) on aging. The FMD diet will be administered 6 times - at monthly intervals. Change in OMICm methylation from baseline to Week 24

  2. Effect of weekly low-dose rapamycin on aging based on Tru Diagnostic Tru Age OMICm Age test results.

    Time frame: 24 weeks

    Change in OMICm methylation from baseline to Week 24

  3. Lowering of insulin resistance based on Tru Diagnostic Tru Age OMICm Age test results.

    Time frame: 24 weeks

    To evaluate the combined effects of AMPK and low-dose weekly rapamycin, at lowering insulin resistance, and thereby PI3K (PI3 kinase).

  4. Effects on insulin resistance

    Time frame: 24 weeks

    To stratify outcomes of the prior three outcomes based on insulin resistance. This will be monitored using a Quest Lab Insulin Resistance panel to determine if insulin resistance is a confounding variable from any of the above. Variability of results in a, b, or c based on high, low or moderate insulin resistance.

  5. Does reversal of age improve cognition based on the Cognitive Flexibility Inventory.

    Time frame: 24 weeks

    Changes in the Cognitive Flexibility Inventory from baseline to week 24. Scores range from 20-140, with a higher score representing a better outcome.

  6. Patterns based on Age based on Tru Diagnostic Tru Age OMICm Age test results.

    Time frame: 24 weeks

    To see if any pattern exists within age group categories. (50-65; older than age 65). Change in OMICm methylation results from baseline to Week 24 by two sub populations: ages 50-65 and ages older than age 65

  7. Sex Difference based on Tru Diagnostic Tru Age OMICm Age test results.

    Time frame: 24 weeks

    Change in OMICm methylation from baseline to Week 24 by male vs female

  8. Safety and tolerability of rapamycin and Prolon

    Time frame: 28 weeks

    Review of adverse reactions from baseline to Week 28

Sponsors and collaborators

Lead sponsor

The Christ Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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