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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


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