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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

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.


Condition or disease Intervention/treatment Phase
Insulin Resistance Other: Periodic fasting Other: Energy restriction Other: Energy balance diet Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Periodic Fasting Versus Daily Energy Restriction on Metabolic Health
Study Start Date : January 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Arm Intervention/treatment
Experimental: Daily energy restriction
25% reduction in daily energy intake
Other: Energy restriction
Active Comparator: Energy balance diet
Diet provides 100% of energy requirements and is designed to achieve weight stability
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
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
Other: Periodic fasting
Other: Energy balance diet



Primary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: 8 weeks ]
    assessed by hyperinsulinemic euglycemic clamp


Secondary Outcome Measures :
  1. Plasma hormones and adipokines [ Time Frame: 8 weeks ]
  2. Cognitive function, hunger, and mood [ Time Frame: 8 weeks ]
  3. Oxidative stress, stress resistance, and lipid metabolism [ Time Frame: 8 weeks ]
  4. Energy expenditure [ Time Frame: 8 weeks ]
    resting energy expenditure, and total daily energy expenditure



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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01769976


Locations
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5005
Sponsors and Collaborators
University of Adelaide
Investigators
Principal Investigator: Leonie Heilbronn University of Adelaide

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: A/Prof Leonie Heilbronn, Associate Professor, University of Adelaide
ClinicalTrials.gov Identifier: NCT01769976     History of Changes
Other Study ID Numbers: APP1023401
First Posted: January 17, 2013    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases