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

NCT02132091 | Completed

• 4 other identifiers: IRB772011TL1TR000066UL1TR0000641P30AG028740
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Metabolism

Keywords

Sirtuins; Calorie Restriction; Intermittent Fasting; Antioxidant; Aging; Metabolism; Mitochondria; Oxidative Stress

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (14)

• 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

Study Arms (2)

Intermittent Fasting

EXPERIMENTAL

Intermittent Fasting

Other: Intermittent Fasting

Intermittent Fasting + Antioxidants

EXPERIMENTAL

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

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

Interventions

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.

Intermittent Fasting; Intermittent Fasting + Antioxidants

400 IU Vitamin E DIETARY_SUPPLEMENT

once each day in morning; oral pill form

Intermittent Fasting + Antioxidants

1000 mg Vitamin C DIETARY_SUPPLEMENT

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

Intermittent Fasting + Antioxidants

Eligibility Criteria

• Age: 19 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

• 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.

  PMID: 25546413 DERIVED

MeSH Terms

Conditions

Intermittent Fasting

Interventions

Vitamin E; Ascorbic Acid

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Mark L Brantly, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: May 6, 2014
• Study Start: March 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 14, 2015

Record last verified: 2015-12

Locations

US (1)