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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03278236
Ethics application status
Date submitted
7/09/2017
Date registered
11/09/2017

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
BEHAVIORAL - TRF

Experimental: TRF -


BEHAVIORAL: TRF
Participants will be instructed to consume their habitual diet within a self-selected 10 hour period every day.
Intervention code [1] 0 0
BEHAVIORAL
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
Not applicable
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
Stopped early
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Food intake data obtained from the MyCircadianApp will be shared between the researchers and the collaborators.

Supporting document/s available: Informed consent form (ICF)
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT03278236