Rapamycin + Prolon Diet for Aging
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether combining Rapamycin (a drug) and the Prolon diet can slow or even reverse aging. Researchers aim to determine if these treatments can reduce the risk of age-related diseases. The trial includes three groups: one takes Rapamycin, another follows the Prolon diet, and the last group does both. Individuals aged 50 to 80 who are generally healthy and have stable medical conditions might be suitable candidates. As an Early Phase 1 trial, this research focuses on understanding how these treatments work in people, offering participants a chance to contribute to groundbreaking science.
Will I have to stop taking my current medications?
You may continue taking your current medications as long as they do not conflict with rapamycin. However, if you are on high doses of certain medications like verapamil, simvastatin, lovastatin, or atorvastatin, or medications that lower glucose, you may need to adjust or stop them. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that rapamycin is usually well-tolerated by healthy individuals. Studies have not identified any serious side effects directly linked to rapamycin, though reports of increased infections are important to consider.
In the PEARL trial, participants taking low-dose rapamycin for a year tolerated it well. This finding suggests rapamycin might be safe for longer use, although it is not yet approved for aging.
The Prolon diet mimics fasting and, while specific safety data is lacking, it is generally considered safe as it is designed to support health.
In summary, both rapamycin and the Prolon diet appear to have a reasonable safety profile based on current research. However, potential participants should be aware of the increased risk of infections associated with rapamycin.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of rapamycin and the Prolon Diet for aging because it targets the aging process differently than current treatments. Unlike traditional approaches that often focus on managing symptoms of aging, rapamycin works by inhibiting a protein called mTOR, which is linked to cell growth and aging. The Prolon Diet mimics fasting, potentially enhancing the effects of rapamycin by promoting cellular repair and regeneration. This innovative combination may offer a more comprehensive approach to slowing down aging than existing methods.
What evidence suggests that this trial's treatments could be effective for aging?
Studies have shown that rapamycin can improve health and extend lifespan in animals by affecting systems related to aging, such as the immune and heart systems. Some research suggests that rapamycin's effects mirror the benefits of calorie restriction, which is known to promote longevity. However, evidence of its anti-aging benefits in humans remains limited. In this trial, participants will be divided into different treatment arms: one group will receive rapamycin only, another will follow the Prolon diet only, and a third group will receive a combination of rapamycin and the Prolon diet. Researchers are studying the combination of rapamycin with the Prolon diet for its potential to slow aging, using new methods to track age-related changes.23678
Are You a Good Fit for This Trial?
This trial is for healthy individuals of any sex and ethnicity, aged between 50 to 80 years old. Participants must be able to give informed consent and have stable medical conditions. They may take other medications if they don't interfere with rapamycin.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Prolon Diet, Rapamycin, or a combination of both. The Prolon Diet is administered as a 5-day diet at 0, 1, 2, 3, 4, and 5 months. Rapamycin is given as a 10 mg initial bolus dose followed by a weekly 6 mg dose.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including changes in OMICm methylation and insulin resistance.
Safety Monitoring
Review of adverse reactions to rapamycin and Prolon from baseline to Week 28.
What Are the Treatments Tested in This Trial?
Interventions
- Prolon diet
- Rapamycin
Trial Overview
The REVERSE Study is testing whether Rapamycin tablets and the Prolon diet can impact the aging process. It uses a new age clock based on methylation patterns to measure changes in the rate of aging.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
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.
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
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;
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Christ Hospital
Lead Sponsor
Citations
Rapamycin for longevity: the pros, the cons, and future ...
Transient, short-term rapamycin treatment in early adulthood improved late-life health outcomes in mice, extending lifespan in both sexes at low ...
Rapamycin for longevity: the pros, the cons, and future ...
Transient, short-term rapamycin treatment in early adulthood improved late-life health outcomes in mice, extending lifespan in both sexes at low ...
Targeting ageing with rapamycin and its derivatives in ...
Rapamycin and its derivatives improved physiological parameters associated with ageing in the immune, cardiovascular, and integumentary systems of healthy ...
What is the clinical evidence to support off-label rapamycin ...
Low dose rapamycin therapy has been proposed as a longevity candidate in healthy aging adults. We present a review of the evidence for low dose ...
Impact of rapamycin on longevity: updated insights
Pharmacological inhi- bition of mTOR by rapamycin has demonstrated intriguing anti-aging properties in multiple organs and extended the lifespan of diverse ...
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aging-us.com
aging-us.com/news-room/rapamycin-shows-limited-evidence-for-longevity-benefits-in-healthy-adultsRapamycin Shows Limited Evidence for Longevity Benefits ...
Overall, while animal studies have demonstrated promising effects, human trials have not yet shown that rapamycin can safely or effectively slow ...
Risks and Benefits for Sirolimus in Aging Prevention - S.
As it is not approved for aging or related indications, there is no recommended dose for use in otherwise healthy subjects. A small pilot study ...
Participatory Evaluation (of) Aging (With) Rapamycin (for) ...
The researchers aim to establish a long-term safety profile, determine the long-term efficacy of Rapamycin in reducing clinical aging measures, and biochemical ...
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