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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01769976




Registration number
NCT01769976
Ethics application status
Date submitted
15/01/2013
Date registered
17/01/2013
Date last updated
2/12/2015

Titles & IDs
Public title
Effects of Periodic Fasting Versus Daily Energy Restriction on Metabolic Health
Scientific title
Effects of Periodic Fasting Versus Daily Energy Restriction on Metabolic Health
Secondary ID [1] 0 0
APP1023401
Universal Trial Number (UTN)
Trial acronym
PREFER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insulin Resistance 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Daily energy restriction - 25% reduction in daily energy intake

Active comparator: Energy balance diet - Diet provides 100% of energy requirements and is designed to achieve weight stability

Experimental: Periodic fasting with weight loss - Fast 3 days per week, and consume 1.5 times usual amount of food on other days

Experimental: Periodic fasting without weight loss - Fast 3 days per week, and consume double usual amount of food on other days
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Insulin sensitivity
Timepoint [1] 0 0
8 weeks
Secondary outcome [1] 0 0
Plasma hormones and adipokines
Timepoint [1] 0 0
8 weeks
Secondary outcome [2] 0 0
Cognitive function, hunger, and mood
Timepoint [2] 0 0
8 weeks
Secondary outcome [3] 0 0
Oxidative stress, stress resistance, and lipid metabolism
Timepoint [3] 0 0
8 weeks
Secondary outcome [4] 0 0
Energy expenditure
Timepoint [4] 0 0
8 weeks

Eligibility
Key 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)
Minimum age
35 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2015
Sample size
Target
Accrual to date
Final
88
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5005 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01769976
Trial related presentations / publications
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Leonie Heilbronn
Address 0 0
University of Adelaide
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01769976