AgingEarly Phase 1NCT07354620
A Pilot Study on Reverse Aging (The REVERSE Study)
A Early Phase 1 study testing Rapamycin (Tablets) and Prolon diet in people with Aging, run by The Christ Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Aging
- What is being tested?
- Rapamycin (Tablets) and Prolon diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2025to May 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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 locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Aging
- Being tested
- Rapamycin (Tablets), Prolon diet
- Keywords
- Aging, Reverse Aging, Rapamycin, Biological Age, Chronological Age, Prolon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapamycin (Tablets)Drug
10 mg initial bolus dose of rapamycin followed by a weekly 6 mg rapamycin
Prolon dietDietary supplement
Prolon 5-day diet at 0, 1, 2, 3, 4,and 5 months
| Study group | Role | What they receive |
|---|---|---|
| Rapamycin Only | Experimental | 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 Receives: Drug: Rapamycin (Tablets) |
| Prolon Diet Only | Active comparator | 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; Receives: Dietary Supplement: Prolon diet |
| Rapamycin and Prolon Diet | Experimental | 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. Receives: Drug: Rapamycin (Tablets); Dietary Supplement: Prolon diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Biological Age from Baseline to End of Study based on Tru Diagnostic Tru Age OMICm Age test results.
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.
Measured: 24 weeks
Secondary outcomes (8)
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.
. 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
Measured: 24 weeks
Effect of weekly low-dose rapamycin on aging based on Tru Diagnostic Tru Age OMICm Age test results.
Change in OMICm methylation from baseline to Week 24
Measured: 24 weeks
Lowering of insulin resistance based on Tru Diagnostic Tru Age OMICm Age test results.
To evaluate the combined effects of AMPK and low-dose weekly rapamycin, at lowering insulin resistance, and thereby PI3K (PI3 kinase).
Measured: 24 weeks
Effects on insulin resistance
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.
Measured: 24 weeks
Does reversal of age improve cognition based on the Cognitive Flexibility Inventory.
Changes in the Cognitive Flexibility Inventory from baseline to week 24. Scores range from 20-140, with a higher score representing a better outcome.
Measured: 24 weeks
Patterns based on Age based on Tru Diagnostic Tru Age OMICm Age test results.
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
Measured: 24 weeks
Sex Difference based on Tru Diagnostic Tru Age OMICm Age test results.
Change in OMICm methylation from baseline to Week 24 by male vs female
Measured: 24 weeks
Safety and tolerability of rapamycin and Prolon
Review of adverse reactions from baseline to Week 28
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start15 Feb 2025
- Primary completionFeb 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Christ Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steve Amoils, The Christ Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354620
- Sponsor's protocol ID
- 24-088
- Status last verified
- Jan 2026
- First submitted
- 11 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on Reverse Aging (The REVERSE Study)
- ClinicalTrials.gov ID
- NCT07354620
- Acronym / sponsor ID
- 24-088
- Conditions
- Aging
- Keywords
- Aging, Reverse Aging, Rapamycin, Biological Age, Chronological Age, Prolon
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- The Christ HospitalUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 21 Jan 2026 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rapamycin Only | Experimental | Drug: Rapamycin (Tablets)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 |
| Prolon Diet Only | Active comparator | Dietary Supplement: Prolon diet12 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; |
| Rapamycin and Prolon Diet | Experimental | Drug: Rapamycin (Tablets), Dietary Supplement: Prolon diet24 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
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 |
|---|---|---|
| Rapamycin (Tablets)10 mg initial bolus dose of rapamycin followed by a weekly 6 mg rapamycin | Drug | Rapamycin Only, Rapamycin and Prolon Diet |
| Prolon dietProlon 5-day diet at 0, 1, 2, 3, 4,and 5 months | Dietary supplement | Prolon Diet Only, Rapamycin and Prolon Diet |
Primary outcome
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.
8 secondary outcomes
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
Effect of weekly low-dose rapamycin on aging based on Tru Diagnostic Tru Age OMICm Age test results.
Time frame: 24 weeks
Lowering of insulin resistance based on Tru Diagnostic Tru Age OMICm Age test results.
Time frame: 24 weeks
Effects on insulin resistance
Time frame: 24 weeks
Does reversal of age improve cognition based on the Cognitive Flexibility Inventory.
Time frame: 24 weeks
Patterns based on Age based on Tru Diagnostic Tru Age OMICm Age test results.
Time frame: 24 weeks
Sex Difference based on Tru Diagnostic Tru Age OMICm Age test results.
Time frame: 24 weeks
Safety and tolerability of rapamycin and Prolon
Time frame: 28 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Rapamycin (Tablets) and Prolon diet in people with Aging, run by The Christ Hospital at 1 site in United States.
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 5 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 21 Jan 2026. 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 States. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change in Biological Age from Baseline to End of Study based on Tru Diagnostic Tru Age OMICm Age test results. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2026.