Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001182280
Ethics application status
Approved
Date submitted
11/07/2018
Date registered
17/07/2018
Date last updated
15/09/2020
Date data sharing statement initially provided
4/06/2019
Date results provided
15/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring how chronic disruption of circadian rhythm with mistimed sleep influence the appetite
Scientific title
Social jetlag and hedonic feeding – an exploratory research
Secondary ID [1] 295500 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 308767 0
Condition category
Condition code
Diet and Nutrition 307701 307701 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Exposure observed: chronic circadian rhythm disruption with mistimed sleep (as assessed by social jetlag) and its interaction with chronic partial sleep deprivation. There will be 2 exposure groups - 1 with social jetlag and with chronic partial sleep deprivation and 1 with social jetlag and without chronic partial sleep deprivation.
Condition observed: appetite and hedonic eating

This will be a cross-sectional study with 2 study visits. Therefore no follow-up is planned.
Total duration of the study for participants: 1 study visit of 2 hours. In the a sub-group with fMRI the total study duration for participants will be 2 visits of 2 hours separated by 1 week.
Intervention code [1] 301820 0
Early Detection / Screening
Comparator / control treatment
Control groups: 1 group without social jetlag and with chronic partial sleep deprivation and 1 group without social jetlag and without chronic partial sleep deprivation
Control group
Active

Outcomes
Primary outcome [1] 306693 0
hedonic appetite sensation assessed using 100mm visual analogue scales
Timepoint [1] 306693 0
at first study visit
Secondary outcome [1] 349265 0
functional connectivity of the areas of reward associated circuitry (amygdala, insula, striatum, anterior cingulate cortex, orbitofrontal cortex) by functional MRI
Timepoint [1] 349265 0
at Visit 2, 1 week after Visit 1
Secondary outcome [2] 349266 0
appetite sensation assessed by serum assays for neuropeptide Y
Timepoint [2] 349266 0
Visit 1
Secondary outcome [3] 349503 0
appetite sensation assessed by serum assays for ghrelin
Timepoint [3] 349503 0
Visit 1
Secondary outcome [4] 349504 0
appetite sensation assessed by serum assays for leptin
Timepoint [4] 349504 0
Visit 1
Secondary outcome [5] 349505 0
appetite sensation assessed by serum assays for 2-arachidonoylglycerol
Timepoint [5] 349505 0
Visit 1
Secondary outcome [6] 349506 0
appetite sensation assessed by serum assays for nesfatin-1
Timepoint [6] 349506 0
Visit 1
Secondary outcome [7] 349507 0
appetite sensation assessed by serum assays for insulinemia
Timepoint [7] 349507 0
Visit 1

Eligibility
Key inclusion criteria
1. Healthy adults 18-50 years of age
2. Caffeine consumption less than or equal to 350 mg/day
3. Alcohol consumption less than or equal to 6 standard drinks/week
4. No use of any medication
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Any acute illness within 2 weeks before study inclusion or at enrolment
2. Any chronic diseases (including obesity as defined by BMI)
3. Any psychiatric disorders at enrolment (including anxiety, depression, anorexia, bulimia, nocturnal eating)
4. Working in shifts
5. Jetlag resulting from flight across more than 2 time zones within 3 months before study inclusion
6. Pregnancy and lactation
7. Menopause
8. Refuse to participate

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/09/2018
Actual
3/09/2018
Date of last participant enrolment
Anticipated
2/09/2019
Actual
4/12/2019
Date of last data collection
Anticipated
9/09/2019
Actual
4/12/2019
Sample size
Target
80
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 10635 0
Romania
State/province [1] 10635 0

Funding & Sponsors
Funding source category [1] 300085 0
Self funded/Unfunded
Name [1] 300085 0
None
Country [1] 300085 0
Primary sponsor type
Individual
Name
Adriana Rusu
Address
2-4 Clinicilor Street, 400006 Cluj-Napoca, Romania
Department of Diabetes and Nutrition Diseases
Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca
Country
Romania
Secondary sponsor category [1] 299487 0
None
Name [1] 299487 0
Address [1] 299487 0
Country [1] 299487 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300933 0
Ethics Committee of the Iuliu Hatieganu University of Medicine and Pharmacy
Ethics committee address [1] 300933 0
Ethics committee country [1] 300933 0
Romania
Date submitted for ethics approval [1] 300933 0
11/05/2018
Approval date [1] 300933 0
31/05/2018
Ethics approval number [1] 300933 0
242/31.05.2018

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85326 0
Dr Adriana Rusu
Address 85326 0
Iuliu Hatieganu University of Medicine and Pharmacy
Department of Diabetes and Nutrition
2-4 Clinicilor Street
400006 Cluj-Napoca
Country 85326 0
Romania
Phone 85326 0
+40729114519
Fax 85326 0
Email 85326 0
[email protected]
Contact person for public queries
Name 85327 0
Adriana Rusu
Address 85327 0
Iuliu Hatieganu University of Medicine and Pharmacy
Department of Diabetes and Nutrition
2-4 Clinicilor Street
400006 Cluj-Napoca
Country 85327 0
Romania
Phone 85327 0
+40729114519
Fax 85327 0
Email 85327 0
[email protected]
Contact person for scientific queries
Name 85328 0
Adriana Rusu
Address 85328 0
Iuliu Hatieganu University of Medicine and Pharmacy
Department of Diabetes and Nutrition
2-4 Clinicilor Street
400006 Cluj-Napoca
Country 85328 0
Romania
Phone 85328 0
+40729114519
Fax 85328 0
Email 85328 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.