ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Obesity

Condition category

Condition code

Diet and Nutrition

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]

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]

hedonic appetite sensation assessed using 100mm visual analogue scales

Timepoint [1]

at first study visit

Secondary outcome [1]

functional connectivity of the areas of reward associated circuitry (amygdala, insula, striatum, anterior cingulate cortex, orbitofrontal cortex) by functional MRI

Timepoint [1]

at Visit 2, 1 week after Visit 1

Secondary outcome [2]

appetite sensation assessed by serum assays for neuropeptide Y

Timepoint [2]

Visit 1

Secondary outcome [3]

appetite sensation assessed by serum assays for ghrelin

Timepoint [3]

Visit 1

Secondary outcome [4]

appetite sensation assessed by serum assays for leptin

Timepoint [4]

Visit 1

Secondary outcome [5]

appetite sensation assessed by serum assays for 2-arachidonoylglycerol

Timepoint [5]

Visit 1

Secondary outcome [6]

appetite sensation assessed by serum assays for nesfatin-1

Timepoint [6]

Visit 1

Secondary outcome [7]

appetite sensation assessed by serum assays for insulinemia

Timepoint [7]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Romania

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

None

Address [1]

None

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics Committee of the Iuliu Hatieganu University of Medicine and Pharmacy

Ethics committee address [1]

8 Victor Babes Street, 400012 Cluj-Napoca, Cluj County

Ethics committee country [1]

Romania

Date submitted for ethics approval [1]

11/05/2018

Approval date [1]

31/05/2018

Ethics approval number [1]

242/31.05.2018

Summary

Brief summary

The circadian system has reciprocal neural connections to the brain regions that regulate arousal and sleep and thus, the sleep and circadian control system are closely intertwined. Experimental evidences showed that circadian system disruption interacts with timing of sleep and that mistimed sleep can in turn disrupt the circadian timing system. Very few is known on the mechanisms mediating the link between circadian rhythm disruptions and obesity risk. In this context, we hypothesize that chronic small disruptions of circadian rhythm with mistimed sleep alters hedonic food processing and that it interacts with sleep duration in inducing these alterations.
As form of chronic disruption of circadian rhythm with mistimed sleep will be investigated social jetlag, the most frequent form of circadian rhythm disturbance and resulting from a misalignment between an individual’s endogenous circadian clock and actual sleep times.
The main objective of this cross-sectional research is to investigate the impact social jetlag on hedonic eating in healthy subjects during free living conditions.
For fulfilling its objectives the research will have a main study and fMRI sub-study.
Main study – 80 subjects in 4 study groups (40 subjects with social jetlag [20 with short sleep duration (<7 hours/night); 20 with normal sleep duration]; 40 subjects without social jetlag [20 with short sleep duration; 20 with normal sleep duration]) matched for age, sex and BMI
fMRI sub-study – 28 right-handed subjects in 4 study groups (14 subjects with social jetlag [7 with short sleep duration; 7 with normal sleep duration]; 14 subjects without social jetlag [7 with short sleep duration; 7 normal sleep duration]) matched for age, sex and BMI

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Adriana Rusu

Address

Iuliu Hatieganu University of Medicine and Pharmacy
Department of Diabetes and Nutrition
2-4 Clinicilor Street
400006 Cluj-Napoca

Country

Romania

Phone

+40729114519

Fax

adriana.rusu@umfcluj.ro

Contact person for public queries

Name

Adriana Rusu

Address

Iuliu Hatieganu University of Medicine and Pharmacy
Department of Diabetes and Nutrition
2-4 Clinicilor Street
400006 Cluj-Napoca

Country

Romania

Phone

+40729114519

Fax

adriana.rusu@umfcluj.ro

Contact person for scientific queries

Name

Adriana Rusu

Address

Iuliu Hatieganu University of Medicine and Pharmacy
Department of Diabetes and Nutrition
2-4 Clinicilor Street
400006 Cluj-Napoca

Country

Romania

Phone

+40729114519

Fax

adriana.rusu@umfcluj.ro

Data sharing statement

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

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.

Trial Review

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