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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03278236




Registration number
NCT03278236
Ethics application status
Date submitted
7/09/2017
Date registered
11/09/2017
Date last updated
25/05/2018

Titles & IDs
Public title
Does Time Restricted Feeding Improve Glycaemic Control in Overweight Men?
Scientific title
Does Time Restricted Feeding Improve Glycaemic Control in Overweight Men?
Secondary ID [1] 0 0
HREC/17/RAH/307
Universal Trial Number (UTN)
Trial acronym
RESHAPE2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type2 Diabetes 0 0
Insulin Resistance 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - TRF

Experimental: TRF -


Behaviour: TRF
Participants will be instructed to consume their habitual diet within a self-selected 10 hour period every day.
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in glycaemia
Timepoint [1] 0 0
3 hours
Secondary outcome [1] 0 0
Change in HbA1c
Timepoint [1] 0 0
6 weeks
Secondary outcome [2] 0 0
Change in body weight
Timepoint [2] 0 0
6 weeks
Secondary outcome [3] 0 0
Change in waist and hip circumference
Timepoint [3] 0 0
6 weeks
Secondary outcome [4] 0 0
Change in insulin
Timepoint [4] 0 0
3 hours
Secondary outcome [5] 0 0
Change in gut peptides
Timepoint [5] 0 0
3 hours
Secondary outcome [6] 0 0
Change in cardiovascular risk
Timepoint [6] 0 0
6 weeks
Secondary outcome [7] 0 0
Change in appetite
Timepoint [7] 0 0
3 hours
Secondary outcome [8] 0 0
Change in food intake
Timepoint [8] 0 0
6 weeks

Eligibility
Key inclusion criteria
overweight (BMI >25.0 kg/m2) Waist circumference >102 cm
Minimum age
45 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Personal history of cardiovascular disease, diabetes, major psychiatric disorders,
insomnia

- use of prescribed or non-prescribed medications which may affect energy metabolism,
gastrointestinal function, weight or appetite (e.g. domperidone and cisapride,
anticholinergic drugs (e.g. atropine), androgenic medications (e.g. testosterone),
metoclopramide, orlistat, diuretics)

- use of prescribed glucose-lowering/antidiabetic medication (e.g. metformin, DPP4
inhibitors)

- recent weight change in past 3 months, and/or does not habitually eat breakfast

- uncontrolled asthma, current fever, upper respiratory infections

- individuals who regularly perform high intensity exercise (>2 week)

- current intake of > 140g alcohol/week

- current smokers of cigarettes/cigars/marijuana

- current intake of any illicit substance

- current shift worker

- has donated blood within past 3-months

- unable to comprehend study protocol

- does not own a smartphone

Study design
Purpose of the study
Prevention
Allocation to intervention
N/A
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2017
Sample size
Target
Accrual to date
Final
1
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Adelaide Medical School - Adelaide
Recruitment postcode(s) [1] 0 0
5005 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Salk Institute for Biological Studies
Address [1] 0 0
Country [1] 0 0

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 [1]. 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 [2]. Reduced
risk of chronic diseases is also observed in humans following CR [3]. However, daily CR is
difficult to maintain long term, since the body defends against weight loss by inducing
"metabolic adaptation"[3] and altering the hormonal appetite response [4]. An emerging number
of studies are examining the effects of limiting food intake to prescribed time periods per
day, or every other day. Time restricted feeding (TRF) describes a dieting approach where
food is available ad libitum, however only for a limited period of time (i.e. 3-12 hours).

This pilot study will examine the effects of restricting daily food intake to within a 10
hour period on glycaemic control, body weight and biomarkers of metabolic health for 6-weeks.
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03278236
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Leonie Heilbronn, PhD
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/ct2/show/NCT03278236