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NCT Number: NCT02132091

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

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.

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Key information

Conditions

Aging Behavior Fasting Feeding Behavior Intermittent Fasting Metabolism

Age range

19 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32610, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intermittent fasting

Other

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.

400 IU Vitamin E

Dietary Supplement

once each day in morning; oral pill form

1000 mg Vitamin C

Dietary Supplement

500mg twice each day; morning and evening; oral pill form

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 6, 2014
Registry last updated
Dec 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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