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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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; |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapamycin (Tablets) | Drug | 10 mg initial bolus dose of rapamycin followed by a weekly 6 mg rapamycin |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AIM for Wellbeing | Cincinnati | Ohio | 45236 | United States |
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| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D004304 | Dosage Forms |
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| Prolon diet | Dietary Supplement | Prolon 5-day diet at 0, 1, 2, 3, 4,and 5 months |
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| 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 | 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). | 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. | 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. | 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 | 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 | 24 weeks |
| Safety and tolerability of rapamycin and Prolon | Review of adverse reactions from baseline to Week 28 | 28 weeks |
| D004364 |
| Pharmaceutical Preparations |