Clinical trial NCT02132091: Practicality of Intermittent Fasting and Its Effect on Markers of Aging and Oxidative Stress
Official title: The Effect of Intermittent Fasting on Adaptive Oxidative Stress Response and Mitochondrial Biogenesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Metabolism
Keywords: Sirtuins
Calorie Restriction
Intermittent Fasting
Antioxidant
Aging
Metabolism
Mitochondria
Oxidative Stress
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2014-05-06
Enrollment: 37
Sex: ALL
Minimum age (years): 19
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: SOD2 gene expression (intermittent fasting)
timeFrame: 3 weeks
measure: SOD2 gene expression (antioxidant supplementation)
timeFrame: 3 weeks
Secondary outcomes:
measure: GPx1 gene expression (intermittent fasting)
timeFrame: 3 weeks
measure: SIRT1 gene expression (intermittent fasting)
timeFrame: 3 weeks
measure: SIRT3 gene expression (intermittent fasting)
timeFrame: 3 weeks
measure: mTFA gene expression (intermittent fasting)
timeFrame: 3 weeks
measure: NRF1 gene expression (intermittent fasting)
timeFrame: 3 weeks
measure: 8oxodG ratio (intermittent fasting)
timeFrame: 3 weeks
measure: 8oxoG ratio (intermittent fasting)
timeFrame: 3 weeks
measure: GPx1 gene expression (antioxidant supplementation)
timeFrame: 3 weeks
measure: SIRT1 gene expression (antioxidant supplementation)
timeFrame: 3 weeks
measure: SIRT3 gene expression (antioxidant supplementation)
timeFrame: 3 weeks
measure: mFTA gene expression (antioxidant supplementation)
timeFrame: 3 weeks
measure: NRF1 gene expression (antioxidant supplementation)
timeFrame: 3 weeks
measure: 8oxodG ratio (antioxidant supplementation)
timeFrame: 3 weeks
measure: 8oxoG ratio (antioxidant supplementation)
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Mark L Brantly, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.