Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Date last updated
11/10/2018

Titles & IDs
Public title
Intermittent Fasting for Metabolic Health, Does Meal Timing Matter?
Scientific title
Intermittent Fasting for Metabolic Health, Does Meal Timing Matter?
Secondary ID [1] 0 0
UAdelaide
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Insulin Resistance 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Postprandial glucose response to meal test
Timepoint [1] 0 0
3-hours
Secondary outcome [1] 0 0
Postprandial insulin response to test meal
Timepoint [1] 0 0
3 hours
Secondary outcome [2] 0 0
Post-prandial gut hormone response to test meal
Timepoint [2] 0 0
3 hours
Secondary outcome [3] 0 0
Glycaemic response over 1 week by continuous glucose monitoring
Timepoint [3] 0 0
1-week

Eligibility
Key inclusion criteria
* Waist circumference >102cm
* BMI >30 kg/m2
Minimum age
30 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Prevention
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
Crossover
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
1/01/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/07/2018
Sample size
Target
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
University of Adelaide - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT02633722
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.
Public notes

Contacts
Principal investigator
Name 0 0
Leonie Heilbronn, PhD
Address 0 0
The 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/NCT02633722