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

NCT04962464 | Unknown Phase 2

• 1 other identifier: TD-EA-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aging

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Body Mass Index

  Change from baseline to 6 months

Study Arms (4)

Fasting Mimicking Diet + Supplement / Usual Routine

EXPERIMENTAL

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; Behavioral: Fasting Mimicking Diet

Supplement / Usual Routine

EXPERIMENTAL

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

Usual Routine / Fasting Mimicking Diet + Supplement

EXPERIMENTAL

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; Behavioral: Fasting Mimicking Diet

Usual Routine / Supplement

EXPERIMENTAL

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

Interventions

Peak Human Labs calorie mimetic supplement DIETARY_SUPPLEMENT

Supplement

Fasting Mimicking Diet + Supplement / Usual Routine; Supplement / Usual Routine; Usual Routine / Fasting Mimicking Diet + Supplement; Usual Routine / Supplement

Fasting Mimicking Diet BEHAVIORAL

Diet

Fasting Mimicking Diet + Supplement / Usual Routine; Usual Routine / Fasting Mimicking Diet + Supplement

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy individuals
• Age \> 16 years

Sponsors & Collaborators

• TruDiagnostic: lead
• L-Nutra Inc: collaborator
• Peak Human Labs: collaborator

Study Sites (1)

Peak Human Labs

Brampton, Ontario, L6W 3E1, Canada

Location

Related Publications (3)

• 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.

  PMID: 30930169 BACKGROUND

• 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.

  PMID: 26094889 BACKGROUND

• 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.

  PMID: 28343910 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: prospective, randomized trial

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: July 15, 2021
• Study Start: March 10, 2021
• Primary Completion: March 1, 2022
• Study Completion: September 1, 2022
• Last Updated: August 3, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)