An Early Phase 1 interventional study of Rapamycin (Tablets) and Prolon diet in Aging, sponsored by The Christ Hospital. Active, not recruiting at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by The Christ Hospital · Early Phase 1, Interventional, and Prevention
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.
The Christ Hospital is the lead sponsor of 18 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: Rapamycin (Tablets)
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;
Dietary Supplement: Prolon diet
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.
Drug: Rapamycin (Tablets) · Dietary Supplement: Prolon diet
10 mg initial bolus dose of rapamycin followed by a weekly 6 mg rapamycin
Prolon 5-day diet at 0, 1, 2, 3, 4,and 5 months
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.
Time frame: 24 weeks
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
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 24 weeks
Safety and tolerability of rapamycin and Prolon
Review of adverse reactions from baseline to Week 28
Time frame: 28 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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