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

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ClinicalTrials.gov Identifier: NCT02132091
Recruitment Status : Completed
First Posted : May 6, 2014
Last Update Posted : December 14, 2015
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE May 5, 2014
First Posted Date  ICMJE May 6, 2014
Last Update Posted Date December 14, 2015
Study Start Date  ICMJE March 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2014)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02132091 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2014)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Practicality of Intermittent Fasting and Its Effect on Markers of Aging and Oxidative Stress
Official Title  ICMJE The Effect of Intermittent Fasting on Adaptive Oxidative Stress Response and Mitochondrial Biogenesis
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Aging
  • Metabolism
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Intermittent Fasting
    Intermittent Fasting
    Intervention: Other: Intermittent Fasting
  • Experimental: Intermittent Fasting + Antioxidants
    Intermittent Fasting; 400 IU Vitamin E; 1000 mg Vitamin C
    Interventions:
    • Other: Intermittent Fasting
    • Dietary Supplement: 400 IU Vitamin E
    • Dietary Supplement: 1000 mg Vitamin C
Publications * Wegman MP, Guo MH, Bennion DM, Shankar MN, Chrzanowski SM, Goldberg LA, Xu J, Williams TA, Lu X, Hsu SI, Anton SD, Leeuwenburgh C, Brantly ML. Practicality of intermittent fasting in humans and its effect on oxidative stress and genes related to aging and metabolism. Rejuvenation Res. 2015 Apr;18(2):162-72. doi: 10.1089/rej.2014.1624.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 5, 2014)
37
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02132091
Other Study ID Numbers  ICMJE IRB772011
TL1TR000066 ( U.S. NIH Grant/Contract )
UL1TR000064 ( U.S. NIH Grant/Contract )
1P30AG028740 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Mark L Brantly, MD University of Florida
PRS Account University of Florida
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP