ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.


Condition or disease Intervention/treatment Phase
Aging Metabolism Other: Intermittent Fasting Dietary Supplement: 400 IU Vitamin E Dietary Supplement: 1000 mg Vitamin C Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Intermittent Fasting on Adaptive Oxidative Stress Response and Mitochondrial Biogenesis
Study Start Date : March 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants

Arm Intervention/treatment
Experimental: Intermittent Fasting
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




Primary Outcome Measures :
  1. 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


  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



Secondary Outcome Measures :
  1. 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


  2. 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. 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


  4. 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


  5. 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


  6. 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


  7. 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


  8. 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


  9. 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


  10. 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


  11. 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


  12. 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


  13. 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


  14. 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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02132091


Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Investigators
Principal Investigator: Mark L Brantly, MD University of Florida

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02132091     History of Changes
Other Study ID Numbers: IRB772011
TL1TR000066 ( U.S. NIH Grant/Contract )
UL1TR000064 ( U.S. NIH Grant/Contract )
1P30AG028740 ( U.S. NIH Grant/Contract )
First Posted: May 6, 2014    Key Record Dates
Last Update Posted: December 14, 2015
Last Verified: December 2015

Keywords provided by University of Florida:
Sirtuins
Calorie Restriction
Intermittent Fasting
Antioxidant
Aging
Metabolism
Mitochondria
Oxidative Stress

Additional relevant MeSH terms:
Vitamins
Ascorbic Acid
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Antioxidants
Micronutrients
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents