The Impact of a Fast Diet and Calorie Mimetic Supplements on Epigenetic Aging

Study Overview
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Brief Summary
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This is a prospective randomized clinical study of 50 patients to evaluate the fasting mimicking diet program by Prolon with a calorie mimetic supplement from Peak Human Labs. This study will be evaluating the effectiveness of the combined intervention over a three month program. The study will assess the effects that the program has on the participants' biological aging.

Official Title
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The Impact of Fasting Mimicking Diet Program and Calorie Mimetic Supplements on Epigenetic Aging

Conditions
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Aging

Intervention / Treatment
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* Dietary Supplement: Peak Human Labs calorie mimetic supplement
* Behavioral: Fasting Mimicking Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy individuals Age > 16 years

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: prospective, randomized trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fasting Mimicking Diet + Supplement / Usual Routine<br>Participants in will be asked to begin the Peak Human Labs calorie mimetic supplement. They will also begin on day 1 the 5 day Fasting Mimicking Diet Program. Participants will continue the supplementation for the 90 days and repeat the 5 day Fasting Mimicking Diet Program on days 1, 29 and 57. Starting at day 91, they will return to their usual daily routine. | Dietary Supplement: Peak Human Labs calorie mimetic supplement<br>* Supplement<br>Behavioral: Fasting Mimicking Diet<br>* Diet<br>|
| Experimental: Supplement / Usual Routine<br>Participants will be asked to begin the Peak Human Labs calorie mimetic supplement. Participants will continue the supplementation for 90 days. Starting at day 91, they will return to their usual daily routine. | Dietary Supplement: Peak Human Labs calorie mimetic supplement<br>* Supplement<br>|
| Experimental: Usual Routine / Fasting Mimicking Diet + Supplement<br>Participants will have no intervention for the first 90 days, during which they will be asked not to start a new fasting program supplement. At day 91, they will begin the 5-day Fasting Mimicking Diet Program and start the Peak Human Labs calorie mimetic supplement. Participants will continue the supplementation for 90 days and repeat the 5-day Fasting Mimicking Diet Program on days 91, 120, and 148. | Dietary Supplement: Peak Human Labs calorie mimetic supplement<br>* Supplement<br>Behavioral: Fasting Mimicking Diet<br>* Diet<br>|
| Experimental: Usual Routine / Supplement<br>Participants will have no intervention for the first 90 days, during which they will be asked not to start a new fasting program supplement. At day 91,start the Peak Human Labs calorie mimetic supplement. Participants will continue the supplementation for 90 days. | Dietary Supplement: Peak Human Labs calorie mimetic supplement<br>* Supplement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epigenetic Age Biomarkers | Outcome epigenetic age testing will test methylation at 850,000 spots on the DNA/ | Change from baseline to 3 months | 
| Epigenetic Age Biomarkers | Outcome epigenetic age testing will test methylation at 850,000 spots on the DNA/ | Change from baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index |  | Change from baseline to 6 months |