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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02132091
• Other study ID #: IRB772011
• Secondary ID: TL1TR000066UL1TR
• Status: Completed
• Phase: N/A
• First received: May 5, 2014
• Last updated: December 11, 2015
• Start date: March 2011
• Est. completion date: November 2011

Study information

• Verified date: December 2015
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 30 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Aging
• Metabolism

Intervention

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
• 1000 mg Vitamin C
500mg twice each day; morning and evening; oral pill form

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Florida	National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SOD2 gene expression (intermittent fasting)	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	No
Primary	SOD2 gene expression (antioxidant supplementation)	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	No
Secondary	GPx1 gene expression (intermittent fasting)	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	No
Secondary	SIRT1 gene expression (intermittent fasting)	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	No
Secondary	SIRT3 gene expression (intermittent fasting)	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	No
Secondary	mTFA gene expression (intermittent fasting)	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	No
Secondary	NRF1 gene expression (intermittent fasting)	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	No
Secondary	8oxodG ratio (intermittent fasting)	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	No
Secondary	8oxoG ratio (intermittent fasting)	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	No
Secondary	GPx1 gene expression (antioxidant supplementation)	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	No
Secondary	SIRT1 gene expression (antioxidant supplementation)	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	No
Secondary	SIRT3 gene expression (antioxidant supplementation)	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	No
Secondary	mFTA gene expression (antioxidant supplementation)	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	No
Secondary	NRF1 gene expression (antioxidant supplementation)	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	No
Secondary	8oxodG ratio (antioxidant supplementation)	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	No
Secondary	8oxoG ratio (antioxidant supplementation)	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	No