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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04962464
• Other study ID #: TD-EA-001
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 10, 2021
• Est. completion date: September 2022

Study information

• Verified date: August 2021
• Source: TruDiagnostic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Healthy individuals

• Age > 16 years

Related Conditions & MeSH terms

• Aging

Intervention

Dietary Supplement:
• Peak Human Labs calorie mimetic supplement
Supplement

Behavioral:
• Fasting Mimicking Diet
Diet

Locations

Country	Name	City	State
Canada	Peak Human Labs	Brampton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
TruDiagnostic	L-Nutra Inc, Peak Human Labs

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epigenetic Age Biomarkers	Outcome epigenetic age testing will test methylation at 850,000 spots on the DNA/	Change from baseline to 3 months
Primary	Epigenetic Age Biomarkers	Outcome epigenetic age testing will test methylation at 850,000 spots on the DNA/	Change from baseline to 6 months
Secondary	Body Mass Index		Change from baseline to 6 months