NCT02132091|Completed
Practicality of Intermittent Fasting and Its Effect on Markers of Aging and Oxidative Stress
The Effect of Intermittent Fasting on Adaptive Oxidative Stress Response and Mitochondrial Biogenesis
Loading search results
The Effect of Intermittent Fasting on Adaptive Oxidative Stress Response and Mitochondrial Biogenesis
Sponsor study identifier
Secondary identifiers
interventional
37
1 country
1
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2011
Actual (reported)Study Completion
November 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
November 2011
Actual (reported)November 2011
Actual (reported)May 5, 2014
Actual (reported)May 6, 2014
Actual (reported)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
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
GPx1 gene expression (intermittent fasting)
3 weeks
SIRT1 gene expression (intermittent fasting)
3 weeks
SIRT3 gene expression (intermittent fasting)
3 weeks
mTFA gene expression (intermittent fasting)
3 weeks
NRF1 gene expression (intermittent fasting)
3 weeks
Intermittent Fasting
Intermittent Fasting; 400 IU Vitamin E; 1000 mg Vitamin C
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.
University of Florida
Gainesville, Florida, 32610, United States
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.
Mark L Brantly, MD
University of Florida
37 participants (actual enrollment reported by the registry).
First Submitted
May 5, 2014
First Posted
May 6, 2014
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Activities for Cognitive Enhancement of Seniors
once each day in morning; oral pill form
500mg twice each day; morning and evening; oral pill form
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
November 2011
Actual (reported)Study Completion
November 2011
Actual (reported)Last Updated
December 14, 2015
Record last verified: 2015-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: