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

University of Florida

Status: Completed

Conditions: Metabolism; Aging

Treatments: Dietary Supplement: 1000 mg Vitamin C; Other: Intermittent Fasting; Dietary Supplement: 400 IU Vitamin E

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02132091

TL1TR000066 (U.S. NIH Grant/Contract)

UL1TR000064 (U.S. NIH Grant/Contract)

IRB772011

1P30AG028740 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 19 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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37 participants in 2 patient groups

Intermittent Fasting

Experimental group

Description:

Intermittent Fasting

Treatment:

Other: Intermittent Fasting

Intermittent Fasting + Antioxidants

Experimental group

Description:

Intermittent Fasting; 400 IU Vitamin E; 1000 mg Vitamin C

Treatment:

Dietary Supplement: 1000 mg Vitamin C

Other: Intermittent Fasting

Dietary Supplement: 400 IU Vitamin E