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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?

Scientific title

Intermittent Fasting for Metabolic Health, Does Meal Timing Matter?

Secondary ID [1]

UAdelaide

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Type 2 Diabetes

Insulin Resistance

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]

BEHAVIORAL

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Postprandial glucose response to meal test

Timepoint [1]

3-hours

Secondary outcome [1]

Postprandial insulin response to test meal

Timepoint [1]

3 hours

Secondary outcome [2]

Post-prandial gut hormone response to test meal

Timepoint [2]

3 hours

Secondary outcome [3]

Glycaemic response over 1 week by continuous glucose monitoring

Timepoint [3]

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

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

University of Adelaide - Adelaide

Recruitment postcode(s) [1]

- 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

Leonie Heilbronn, PhD

Address

The University of Adelaide

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Undecided

No/undecided IPD sharing reason/comment

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

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For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02633722