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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02633722
Registration number
NCT02633722
Ethics application status
Date submitted
15/12/2015
Date registered
17/12/2015
Titles & IDs
Public title
Intermittent Fasting for Metabolic Health, Does Meal Timing Matter?
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Scientific title
Intermittent Fasting for Metabolic Health, Does Meal Timing Matter?
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Secondary ID [1]
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UAdelaide
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes
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Insulin Resistance
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
BEHAVIORAL - Lifestyle intervention B
BEHAVIORAL - Lifestyle Intervention D
Experimental: TRF-b - Participants are instructed to eat between 8am-5pm
Experimental: TRF-d - Participants are instructed to eat only between 12-9pm
No intervention: Baseline - No lifestyle instruction given
BEHAVIORAL: Lifestyle intervention B
Time limiting feeding from 8-5pm (TRFb)
BEHAVIORAL: Lifestyle Intervention D
Time limiting feeding (12-9pm)
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Intervention code [1]
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BEHAVIORAL
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Postprandial glucose response to meal test
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Assessment method [1]
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Timepoint [1]
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3-hours
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Secondary outcome [1]
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Postprandial insulin response to test meal
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Assessment method [1]
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Timepoint [1]
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3 hours
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Secondary outcome [2]
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Post-prandial gut hormone response to test meal
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Assessment method [2]
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Timepoint [2]
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3 hours
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Secondary outcome [3]
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Glycaemic response over 1 week by continuous glucose monitoring
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Assessment method [3]
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Timepoint [3]
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1-week
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Eligibility
Key inclusion criteria
* Waist circumference >102cm
* BMI >30 kg/m2
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Minimum age
30
Years
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Maximum age
70
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Personal history of cardiovascular disease, diabetes, eating disorders
* use of medications which may affect energy metabolism, gastrointestinal function, body weight or appetite (e.g. domperidone and cisapride, anticholinergic drugs, androgenic medications, metoclopramide, orlistat, diuretic medications
* use of prescribed glucose-lowering/antidiabetic medication
* recent weight change in past 3 months,or does not habitually eat breakfast
* uncontrolled asthma, current fever, upper respiratory infections
* current intake of > 140g alcohol/week
* current smokers of cigarettes/cigars/marijuana
* current intake of any illicit substance
* experience claustrophobia in confined spaces
* has donated blood within past 3-months
* unable to comprehend study protocol
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/07/2018
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Sample size
Target
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Accrual to date
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Final
15
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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University of Adelaide - Adelaide
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Recruitment postcode(s) [1]
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- Adelaide
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Adelaide
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Obesity is a serious medical condition, the adverse consequences of which include increased risk of cardiovascular disease, diabetes mellitus, reduced fertility and cancer. The economic cost of obesity was placed at $58 billion dollars in Australia in 2008. Studies in mice and non-human primates have shown that moderate caloric restriction (CR) increases lifespan and reduces the incidence of cardiovascular disease, cancer, and type 2 diabetes. Reduced risk of chronic diseases is also observed in humans following CR. However, daily CR is difficult to maintain long term, since the body defends against weight loss by inducing "metabolic adaptation" and altering the hormonal appetite response. An emerging number of studies are examining the effects of limiting food intake to prescribed time periods per day, or every other day. Intermittent, or time restricted feeding describes a dieting approach where food is available ad libitum, however only for a limited period of time (i.e. 3-12 hours). This study will examine the effects of fasting for 15h/day and eating for 9-h per day on glycemic control and metabolic health. This study will build on the existing knowledge base in humans as to whether meal timing, rather than caloric restriction per se, is important to provide the stimulus required to improve metabolic health and reduce risk of chronic disease. Moreover, it will examine whether restricting feeding to later in the day is of lesser benefit to health.
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Trial website
https://clinicaltrials.gov/study/NCT02633722
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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, Regmi P, Manoogian ENC, Fleischer JG, Wittert GA, Panda S, Heilbronn LK. Time-Restricted Feeding Improves Glucose Tolerance in Men at Risk for Type 2 Diabetes: A Randomized Crossover Trial. Obesity (Silver Spring). 2019 May;27(5):724-732. doi: 10.1002/oby.22449. Epub 2019 Apr 19.
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Public notes
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Contacts
Principal investigator
Name
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Leonie Heilbronn, PhD
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Address
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The University of Adelaide
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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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/NCT02633722