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

NCT ID: NCT04962464

Last Updated: 2021-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-10

Study Completion Date

2022-09-30

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.

Detailed Description

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Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

prospective, randomized trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Peak Human Labs calorie mimetic supplement

Intervention Type DIETARY_SUPPLEMENT

Supplement

Fasting Mimicking Diet

Intervention Type BEHAVIORAL

Diet

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.

Group Type EXPERIMENTAL

Peak Human Labs calorie mimetic supplement

Intervention Type DIETARY_SUPPLEMENT

Supplement

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.

Group Type EXPERIMENTAL

Peak Human Labs calorie mimetic supplement

Intervention Type DIETARY_SUPPLEMENT

Supplement

Fasting Mimicking Diet

Intervention Type BEHAVIORAL

Diet

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.

Group Type EXPERIMENTAL

Peak Human Labs calorie mimetic supplement

Intervention Type DIETARY_SUPPLEMENT

Supplement

Interventions

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Peak Human Labs calorie mimetic supplement

Supplement

Intervention Type DIETARY_SUPPLEMENT

Fasting Mimicking Diet

Diet

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Healthy individuals
* Age \> 16 years
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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L-Nutra Inc

INDUSTRY

Sponsor Role collaborator

Peak Human Labs

UNKNOWN

Sponsor Role collaborator

TruDiagnostic

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peak Human Labs

Brampton, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 30930169 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26094889 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28343910 (View on PubMed)

Other Identifiers

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TD-EA-001

Identifier Type: -

Identifier Source: org_study_id

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