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

Primary Purpose

Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Periodic fasting
Energy restriction
Energy balance diet
Sponsored by
University of Adelaide
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Insulin Resistance

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Royal Adelaide Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Experimental

Arm Label

Daily energy restriction

Energy balance diet

Periodic fasting with weight loss

Periodic fasting without weight loss

Arm Description

25% reduction in daily energy intake

Diet provides 100% of energy requirements and is designed to achieve weight stability

Fast 3 days per week, and consume 1.5 times usual amount of food on other days

Fast 3 days per week, and consume double usual amount of food on other days

Outcomes

Primary Outcome Measures

Insulin sensitivity
assessed by hyperinsulinemic euglycemic clamp

Secondary Outcome Measures

Plasma hormones and adipokines
Cognitive function, hunger, and mood
Oxidative stress, stress resistance, and lipid metabolism
Energy expenditure
resting energy expenditure, and total daily energy expenditure

Full Information

First Posted
January 15, 2013
Last Updated
November 30, 2015
Sponsor
University of Adelaide
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1. Study Identification

Unique Protocol Identification Number
NCT01769976
Brief Title
Effects of Periodic Fasting Versus Daily Energy Restriction on Metabolic Health
Acronym
PREFER
Official Title
Effects of Periodic Fasting Versus Daily Energy Restriction on Metabolic Health
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Adelaide

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daily energy restriction
Arm Type
Experimental
Arm Description
25% reduction in daily energy intake
Arm Title
Energy balance diet
Arm Type
Active Comparator
Arm Description
Diet provides 100% of energy requirements and is designed to achieve weight stability
Arm Title
Periodic fasting with weight loss
Arm Type
Experimental
Arm Description
Fast 3 days per week, and consume 1.5 times usual amount of food on other days
Arm Title
Periodic fasting without weight loss
Arm Type
Experimental
Arm Description
Fast 3 days per week, and consume double usual amount of food on other days
Intervention Type
Other
Intervention Name(s)
Periodic fasting
Intervention Type
Other
Intervention Name(s)
Energy restriction
Intervention Type
Other
Intervention Name(s)
Energy balance diet
Primary Outcome Measure Information:
Title
Insulin sensitivity
Description
assessed by hyperinsulinemic euglycemic clamp
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Plasma hormones and adipokines
Time Frame
8 weeks
Title
Cognitive function, hunger, and mood
Time Frame
8 weeks
Title
Oxidative stress, stress resistance, and lipid metabolism
Time Frame
8 weeks
Title
Energy expenditure
Description
resting energy expenditure, and total daily energy expenditure
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonie Heilbronn
Organizational Affiliation
University of Adelaide
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5005
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
33512717
Citation
Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
Results Reference
derived
PubMed Identifier
30569640
Citation
Hutchison AT, Liu B, Wood RE, Vincent AD, Thompson CH, O'Callaghan NJ, Wittert GA, Heilbronn LK. Effects of Intermittent Versus Continuous Energy Intakes on Insulin Sensitivity and Metabolic Risk in Women with Overweight. Obesity (Silver Spring). 2019 Jan;27(1):50-58. doi: 10.1002/oby.22345.
Results Reference
derived
PubMed Identifier
27524654
Citation
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.
Results Reference
derived

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Effects of Periodic Fasting Versus Daily Energy Restriction on Metabolic Health

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