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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
NA
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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01769976