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

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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

January 15, 2013
January 17, 2013
December 2, 2015
January 2013
September 2015   (Final data collection date for primary outcome measure)
Insulin sensitivity [ Time Frame: 8 weeks ]
assessed by hyperinsulinemic euglycemic clamp
Same as current
Complete list of historical versions of study NCT01769976 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Effects of Periodic Fasting Versus Daily Energy Restriction on Metabolic Health
Effects of Periodic Fasting Versus Daily Energy Restriction on Metabolic Health

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Insulin Resistance
  • Other: Periodic fasting
  • Other: Energy restriction
  • Other: Energy balance diet
  • 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
Chen M, Liu B, Wilkinson D, Hutchison AT, Thompson CH, Wittert GA, Heilbronn LK. Selenoprotein P is elevated in individuals with obesity, but is not independently associated with insulin resistance. Obes Res Clin Pract. 2017 Mar - Apr;11(2):227-232. doi: 10.1016/j.orcp.2016.07.004. Epub 2016 Aug 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
100
September 2015
September 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
35 Years to 70 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT01769976
APP1023401
Yes
Not Provided
Not Provided
A/Prof Leonie Heilbronn, University of Adelaide
University of Adelaide
Not Provided
Principal Investigator: Leonie Heilbronn University of Adelaide
University of Adelaide
November 2015

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