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Effects of Periodic Fasting Versus Daily Energy Restriction on Metabolic Health (PREFER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01769976
Recruitment Status : Completed
First Posted : January 17, 2013
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
A/Prof Leonie Heilbronn, University of Adelaide

Tracking Information
First Submitted Date  ICMJE January 15, 2013
First Posted Date  ICMJE January 17, 2013
Last Update Posted Date December 2, 2015
Study Start Date  ICMJE January 2013
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2013)
Insulin sensitivity [ Time Frame: 8 weeks ]
assessed by hyperinsulinemic euglycemic clamp
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2013)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Periodic Fasting Versus Daily Energy Restriction on Metabolic Health
Official Title  ICMJE Effects of Periodic Fasting Versus Daily Energy Restriction on Metabolic Health
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Insulin Resistance
Intervention  ICMJE
  • Other: Periodic fasting
  • Other: Energy restriction
  • Other: Energy balance diet
Study Arms  ICMJE
  • Experimental: Daily energy restriction
    25% reduction in daily energy intake
    Intervention: Other: Energy restriction
  • Active Comparator: Energy balance diet
    Diet provides 100% of energy requirements and is designed to achieve weight stability
    Intervention: Other: Energy balance diet
  • Experimental: Periodic fasting with weight loss
    Fast 3 days per week, and consume 1.5 times usual amount of food on other days
    Interventions:
    • Other: Periodic fasting
    • Other: Energy restriction
  • Experimental: Periodic fasting without weight loss
    Fast 3 days per week, and consume double usual amount of food on other days
    Interventions:
    • Other: Periodic fasting
    • Other: Energy balance diet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2015)
88
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2013)
100
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 35 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01769976
Other Study ID Numbers  ICMJE APP1023401
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party A/Prof Leonie Heilbronn, University of Adelaide
Study Sponsor  ICMJE University of Adelaide
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Leonie Heilbronn University of Adelaide
PRS Account University of Adelaide
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP