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

November 30, 2015 updated by: A/Prof Leonie Heilbronn, University of Adelaide

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5005
        • Royal Adelaide Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: Energy restriction
Other: Periodic fasting
Experimental: Periodic fasting without weight loss
Fast 3 days per week, and consume double usual amount of food on other days
Other: Energy balance diet
Other: Periodic fasting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin sensitivity
Time Frame: 8 weeks
assessed by hyperinsulinemic euglycemic clamp
8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Adelaide

Investigators

  • Principal Investigator: Leonie Heilbronn, University of Adelaide

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

January 15, 2013

First Submitted That Met QC Criteria

January 15, 2013

First Posted (Estimate)

January 17, 2013

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APP1023401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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