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

Sponsor
TruDiagnostic (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04962464
Collaborator
L-Nutra Inc (Industry), Peak Human Labs (Other)
100
1
4
17.7
5.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Peak Human Labs calorie mimetic supplement
  • Behavioral: Fasting Mimicking Diet
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
prospective, randomized trialprospective, randomized trial
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Impact of Fasting Mimicking Diet Program and Calorie Mimetic Supplements on Epigenetic Aging
Actual Study Start Date :
Mar 10, 2021
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Epigenetic Age Biomarkers [Change from baseline to 3 months]

    Outcome epigenetic age testing will test methylation at 850,000 spots on the DNA/

  2. Epigenetic Age Biomarkers [Change from baseline to 6 months]

    Outcome epigenetic age testing will test methylation at 850,000 spots on the DNA/

Secondary Outcome Measures

  1. Body Mass Index [Change from baseline to 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy individuals

  • Age > 16 years

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peak Human Labs Brampton Ontario Canada L6W 3E1

Sponsors and Collaborators

  • TruDiagnostic
  • L-Nutra Inc
  • Peak Human Labs

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
TruDiagnostic
ClinicalTrials.gov Identifier:
NCT04962464
Other Study ID Numbers:
  • TD-EA-001
First Posted:
Jul 15, 2021
Last Update Posted:
Aug 3, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 3, 2021