Effects of Periodic Fasting Versus Daily Energy Restriction on Metabolic Health

Overview

The aim of this study is to examine whether periodic fasting improves markers of diabetes risk and cardiovascular health, and will compare this to the effects observed with daily dieting by energy restriction, and also with no change in energy intake. It is hypothesized that periodic fasting, with or without weight loss, will be as effective as daily energy restriction to improve markers of metabolic health and energy metabolism.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2015

Interventions

  • Other: Periodic fasting
  • Other: Energy restriction
  • Other: Energy balance diet

Arms, Groups and Cohorts

  • Experimental: Daily energy restriction
    • 25% reduction in daily energy intake
  • Active Comparator: Energy balance diet
    • Diet provides 100% of energy requirements and is designed to achieve weight stability
  • Experimental: Periodic fasting with weight loss
    • Fast 3 days per week, and consume 1.5 times usual amount of food on other days
  • Experimental: Periodic fasting without weight loss
    • Fast 3 days per week, and consume double usual amount of food on other days

Clinical Trial Outcome Measures

Primary Measures

  • Insulin sensitivity
    • Time Frame: 8 weeks
    • assessed by hyperinsulinemic euglycemic clamp

Secondary Measures

  • Plasma hormones and adipokines
    • Time Frame: 8 weeks
  • Cognitive function, hunger, and mood
    • Time Frame: 8 weeks
  • Oxidative stress, stress resistance, and lipid metabolism
    • Time Frame: 8 weeks
  • Energy expenditure
    • Time Frame: 8 weeks
    • resting energy expenditure, and total daily energy expenditure

Participating in This Clinical Trial

Inclusion Criteria

  • Body mass index (BMI) between 25 and 42 kg/m2 – weight stable (<5% fluctuation in body weight for the 6 months prior to study entry) Exclusion Criteria:

  • history of cardiovascular disease, diabetes, major psychiatric disorders, and eating disorders – use of prescribed or non-prescribed medications with may affect energy metabolism, gastrointestinal function, body weight, or appetite – recent weight changes in 3 months prior to study entry – uncontrolled asthma, current fever, upper respiratory infections – individuals who regularly perform high intensity exercise (>2 sessions per week) – pregnancy, lactation (breast feeding), women who are planning to become pregnant – current intake of >140g of alcohol per week – current smoker of cigarettes/cigars/marijuana – current intake of any illicit substance – experience claustrophobia in confined spaces – has donated blood within the past 3 months – unable to comprehend the study protocol – experiences migraines

Gender Eligibility: Female

Minimum Age: 35 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Adelaide
  • Provider of Information About this Clinical Study
    • Principal Investigator: A/Prof Leonie Heilbronn, Associate Professor – University of Adelaide
  • Overall Official(s)
    • Leonie Heilbronn, Principal Investigator, University of Adelaide

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