Practicality of Intermittent Fasting and Its Effect on Markers of Aging and Oxidative Stress

December 11, 2015 updated by: University of Florida

The Effect of Intermittent Fasting on Adaptive Oxidative Stress Response and Mitochondrial Biogenesis

Healthy volunteers will be recruited to participate in a ten-week double-blinded crossover trial. The trial will consist of two, three-week periods of intermittent fasting, where subjects receive either antioxidant supplementation or placebo, the ordering of which will be randomly determined. A one-week preconditioning will precede each invention period, and a two week "wash-out" period will follow the first intervention period. Serum-based assays will be performed to assess levels of reactive oxidant species, antioxidant genes, sirtuins, and markers of mitochondrial biogenesis and aging.

The investigators hypothesize that an intermittent fasting diet in healthy young volunteers will improve these markers of cellular aging and that these beneficial effects will be abrogated by the supplementation of antioxidants. This study is a proof-of-principle study that will shed light on the mechanism and effects of IF as an anti-aging dietary intervention in the absence of weight loss. It will inform the design of dietary interventions that are both effective in improving markers of aging and feasible for patients to practice on a long-term basis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body mass index in the range of 20.0-30.0 kg/m2;
  • Age between 19 and 30;
  • Stable weight (change <±10%) for 3 months immediately prior to the study
  • No history of metabolic disorders (e.g. non-diabetic), cardiovascular disease, or thyroid dysfunction
  • No past or present eating disorders
  • No acute or chronic inflammatory disorder
  • No more than moderate physical activity (i.e.,<3 hour/week of light exercise sessions for the past 3 months)
  • No current medications to regulate blood sugar or lipids
  • Not donated blood within 56 days of study start date
  • No food allergies
  • No dietary restrictions (e.g. vegetarianism and vegan)
  • No heavy drinking (more than 15 drinks/week)
  • No use of tobacco or recreational drugs within past 3 months
  • Access to a microwave or stove
  • Access to refrigeration

Exclusion Criteria:

  • Inflexibility of schedule such that subject cannot attend blood draw appointments
  • Unwillingness to pick-up and eat only study-provided food during the 8 weeks in which it is provided and for unwillingness to abstain from travel (>48hrs) during these same 8 weeks of the trial (travel is permitted during wash-out period)
  • Unwillingness to abstain from tobacco, alcohol, recreational drugs, resveratrol or antioxidant supplements (other than study-provided) for the duration of study
  • Women who are pregnant, breast-feeding or trying to become pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intermittent Fasting
Other: Intermittent Fasting
The intermittent fasting paradigm used in this study will require participants to alternate between days of feasting (175% of normal caloric intake) and fasting ( 25% of normal caloric intake). Food will be provided by University of Florida Clinical Research Center with macronutrient composition prepared according to the 2010 Dietary Guidelines for Americans.
Experimental: Intermittent Fasting + Antioxidants
Intermittent Fasting; 400 IU Vitamin E; 1000 mg Vitamin C
Other: Intermittent Fasting
The intermittent fasting paradigm used in this study will require participants to alternate between days of feasting (175% of normal caloric intake) and fasting ( 25% of normal caloric intake). Food will be provided by University of Florida Clinical Research Center with macronutrient composition prepared according to the 2010 Dietary Guidelines for Americans.
Dietary supplement: 400 IU Vitamin E
once each day in morning; oral pill form
Dietary supplement: 1000 mg Vitamin C
500mg twice each day; morning and evening; oral pill form

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SOD2 gene expression (intermittent fasting)
Time Frame: 3 weeks

Observational outcome examines difference in expression between a normal diet and a 3-week intermittent fasting diet using RNA extracted from venous blood.

Note: SOD2 = Superoxide-dismutase-2
3 weeks
SOD2 gene expression (antioxidant supplementation)
Time Frame: 3 weeks

Experimental outcome examining differences between intermittent fasting with supplementation of antioxidants and intermittent fasting alone using RNA extracted from venous blood.

Note: SOD2 = Superoxide-dismutase-2
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GPx1 gene expression (intermittent fasting)
Time Frame: 3 weeks

Observational outcome examines difference in expression between a normal diet and a 3-week intermittent fasting diet using RNA extracted from venous blood.

Note: GPx1 = Glutathione peroxidase 1
3 weeks
SIRT1 gene expression (intermittent fasting)
Time Frame: 3 weeks

Observational outcome examines difference in expression between a normal diet and a 3-week intermittent fasting diet using RNA extracted from venous blood.

Note SIRT1 = Sirtuin 1
3 weeks
SIRT3 gene expression (intermittent fasting)
Time Frame: 3 weeks

Observational outcome examines difference in expression between a normal diet and a 3-week intermittent fasting diet using RNA extracted from venous blood.

Note SIRT3 = Sirtuin 3
3 weeks
mTFA gene expression (intermittent fasting)
Time Frame: 3 weeks

Observational outcome examines difference in expression between a normal diet and a 3-week intermittent fasting diet using RNA extracted from venous blood.

Note: mTFA = mitochondrial transcription factor a
3 weeks
NRF1 gene expression (intermittent fasting)
Time Frame: 3 weeks

Observational outcome examines difference in expression between a normal diet and a 3-week intermittent fasting diet using RNA extracted from venous blood.

Note NRF1 = Nuclear respiratory factor 1
3 weeks
8oxodG ratio (intermittent fasting)
Time Frame: 3 weeks

Observational outcome examines difference in expression between a normal diet and a 3-week intermittent fasting diet using DNA extracted from venous blood.

Note: 8oxodG = 8-oxo-7,8-dihydro-2'-deoxyguanosine/2-deoxyguanosine
3 weeks
8oxoG ratio (intermittent fasting)
Time Frame: 3 weeks

Observational outcome examines difference in expression between a normal diet and a 3-week intermittent fasting diet using RNA extracted from venous blood.

Note: 8oxoG ratio = 8-oxo-7,8 dihydroguanosine/guanosine
3 weeks
GPx1 gene expression (antioxidant supplementation)
Time Frame: 3 weeks

Experimental outcome examining differences between intermittent fasting with supplementation of antioxidants and intermittent fasting alone using RNA extracted from venous blood.

Note: GPx1 = Glutathione peroxidase 1
3 weeks
SIRT1 gene expression (antioxidant supplementation)
Time Frame: 3 weeks

Experimental outcome examining differences between intermittent fasting with supplementation of antioxidants and intermittent fasting alone using RNA extracted from venous blood.

Note SIRT1 = Sirtuin 1
3 weeks
SIRT3 gene expression (antioxidant supplementation)
Time Frame: 3 weeks

Experimental outcome examining differences between intermittent fasting with supplementation of antioxidants and intermittent fasting alone using RNA extracted from venous blood.

Note SIRT3 = Sirtuin 3
3 weeks
mFTA gene expression (antioxidant supplementation)
Time Frame: 3 weeks

Experimental outcome examining differences between intermittent fasting with supplementation of antioxidants and intermittent fasting alone using RNA extracted from venous blood.

Note: mTFA = mitochondrial transcription factor a
3 weeks
NRF1 gene expression (antioxidant supplementation)
Time Frame: 3 weeks

Experimental outcome examining differences between intermittent fasting with supplementation of antioxidants and intermittent fasting alone using RNA extracted from venous blood.

Note NRF1 = Nuclear respiratory factor 1
3 weeks
8oxodG ratio (antioxidant supplementation)
Time Frame: 3 weeks

Experimental outcome examining differences between intermittent fasting with supplementation of antioxidants and intermittent fasting alone using DNA extracted from venous blood.

Note: 8oxodG ratio = 8-oxo-7,8-dihydro-2'-deoxyguanosine/2-deoxyguanosine
3 weeks
8oxoG ratio (antioxidant supplementation)
Time Frame: 3 weeks

Experimental outcome examining differences between intermittent fasting with supplementation of antioxidants and intermittent fasting alone using RNA extracted from venous blood.

Note: 8oxoG ratio = 8-oxo-7,8 dihydroguanosine/guanosine
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

National Institutes of Health (NIH)
National Institute on Aging (NIA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

May 5, 2014

First Submitted That Met QC Criteria

May 5, 2014

First Posted (Estimate)

May 6, 2014

Study Record Updates

Last Update Posted (Estimate)

December 14, 2015

Last Update Submitted That Met QC Criteria

December 11, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB772011
  • TL1TR000066 (U.S. NIH Grant/Contract)
  • UL1TR000064 (U.S. NIH Grant/Contract)
  • 1P30AG028740 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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