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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aging
• Intervention / Treatment: Dietary supplement: Peak Human Labs calorie mimetic supplement; Behavioral: Fasting Mimicking Diet

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Brampton, Ontario, Canada, L6W 3E1
      • Peak Human Labs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy individuals
• Age > 16 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fasting Mimicking Diet + Supplement / Usual Routine; 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; Supplement; Behavioral: Fasting Mimicking Diet; Diet
Experimental: Supplement / Usual Routine; 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; Supplement
Experimental: Usual Routine / Fasting Mimicking Diet + Supplement; 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; Supplement; Behavioral: Fasting Mimicking Diet; Diet
Experimental: Usual Routine / Supplement; 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; Supplement

What is the study measuring?

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	Time Frame
Body Mass Index	Change from baseline to 6 months

Collaborators and Investigators

• Sponsor: TruDiagnostic
• Collaborators: L-Nutra Inc; Peak Human Labs

Publications and helpful links

General Publications

• Brandhorst S, Choi IY, Wei M, Cheng CW, Sedrakyan S, Navarrete G, Dubeau L, Yap LP, Park R, Vinciguerra M, Di Biase S, Mirzaei H, Mirisola MG, Childress P, Ji L, Groshen S, Penna F, Odetti P, Perin L, Conti PS, Ikeno Y, Kennedy BK, Cohen P, Morgan TE, Dorff TB, Longo VD. A Periodic Diet that Mimics Fasting Promotes Multi-System Regeneration, Enhanced Cognitive Performance, and Healthspan. Cell Metab. 2015 Jul 7;22(1):86-99. doi: 10.1016/j.cmet.2015.05.012. Epub 2015 Jun 18.
• Amano H, Chaudhury A, Rodriguez-Aguayo C, Lu L, Akhanov V, Catic A, Popov YV, Verdin E, Johnson H, Stossi F, Sinclair DA, Nakamaru-Ogiso E, Lopez-Berestein G, Chang JT, Neilson JR, Meeker A, Finegold M, Baur JA, Sahin E. Telomere Dysfunction Induces Sirtuin Repression that Drives Telomere-Dependent Disease. Cell Metab. 2019 Jun 4;29(6):1274-1290.e9. doi: 10.1016/j.cmet.2019.03.001. Epub 2019 Mar 28.
• Chen J, Li Y, Zhu Q, Li T, Lu H, Wei N, Huang Y, Shi R, Ma X, Wang X, Sheng J. Anti-skin-aging effect of epigallocatechin gallate by regulating epidermal growth factor receptor pathway on aging mouse model induced by d-Galactose. Mech Ageing Dev. 2017 Jun;164:1-7. doi: 10.1016/j.mad.2017.03.007. Epub 2017 Mar 24.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2021
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: July 12, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): August 3, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: TD-EA-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No