Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000351112
Ethics application status
Approved
Date submitted
28/02/2019
Date registered
6/03/2019
Date last updated
11/03/2020
Date data sharing statement initially provided
6/03/2019
Date results provided
11/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A novel biomarker of food addiction: an investigation in females to determine if plasma oxytocin concentrations are associated with food addiction and if oxytocin concentrations are changed in response to visual food cues.
Scientific title
A novel biomarker of food addiction: a pilot study in females to determine if plasma oxytocin concentrations are associated with food addiction and if oxytocin concentrations are responsive to visual food stimuli.
Secondary ID [1] 290245 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Food addiction 300453 0
Obesity 311748 0
Condition category
Condition code
Diet and Nutrition 300309 300309 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete complete a series of standardised questionnaires (i.e. The Australian Eating Survey, Yale Food Addiction Scale, Depression Anxiety and Stress Scales, Substance Use Risk Profile Scale, Binge Eating Scale, Alcohol, Smoking and Substance Involvement Screening Test) prior to attending a one-off experimental session at the University of Newcastle. On arrival, following an overnight fast, participants will have their height and weight measured and complete a self-report measure of current hunger (Visual Analogue Scale). Participants will be randomly allocated (block design) via computer-based program to one of two groups. An initial blood sample will be collected (time point 1), participants will then view a 10 minute paradigm of food images (group 1 to view healthy images and group 2 to view hyperpalatable foods) presented on a laptop computer (PowerPoint slideshow). Immediately after viewing the images participants will undergo a second blood test (time point 2), and then remain in a controlled environment where there was no visual stimuli for 15 min (wash-out period). A third blood sample will then be collected prior to viewing the second image paradigm, opposite of the first set of food images (time point 3). After this set of images participants will undergo a fourth blood test (time point 4). Participants will then complete another hunger rating scale before consuming a standardised breakfast. The session will take approximately 60 min to complete and participants will be reimbursed AUD50 for travel and time.

Image paradigms: all stimuli to be used in this task has previously been rated in a pilot study (n=10 adults, independent of those involved in the present study) to ensure foods are representative of each of the two categories, and food images are readily identifiable i.e. recognisable and familiar, and shown in an appetising manner for Australian adults. Images are from a licensed database and non-copyrighted sources. Healthy food pictures are based on the five core food groups, and hyperpalatable food pictures based on foods categorised as discretionary choices, outlined in The Australian Guide to Healthy Eating. Visual Analogue Scale (VAS) will provide pre and post summary scores to aid in determining if the image paradigms were effective in eliciting appetite and hunger responses (measure of intervention adherence).

To maintain fidelity the experimental sessions will be conducted in the same laboratory room and the same two research staff will conduct the sessions each time. On each occasion, one researcher (registered dietitian) will record anthropometric measures and implement the intervention, and the other researcher (trained phlebotomist) will collect pre and post blood samples.
Intervention code [1] 296032 0
Other interventions
Comparator / control treatment
Participants act as their own control (crossover study)
Control group
Active

Outcomes
Primary outcome [1] 299795 0
Plasma concentrations of oxytocin
Timepoint [1] 299795 0
Baseline and immediately after each image paradigm
Secondary outcome [1] 328157 0
Plasma concentrations of ghrelin assessed by enzyme-linked immunoassay (ELISA)
Timepoint [1] 328157 0
Baseline and immediately after each image paradigm
Secondary outcome [2] 367748 0
Plasma concentrations of leptin assessed by ELISA
Timepoint [2] 367748 0
Baseline and immediately after each image paradigm
Secondary outcome [3] 367749 0
Plasma concentrations of cholecystokinin assessed by ELISA
Timepoint [3] 367749 0
Baseline and immediately after each image paradigm
Secondary outcome [4] 367750 0
Plasma concentrations of cortisol assessed by ELISA
Timepoint [4] 367750 0
Baseline and immediately after each image paradigm

Eligibility
Key inclusion criteria
Females 18-85yrs, able to comprehend English, willing to attend the University of Newcastle for a one off occasion. Females with and without food addiction, from a previous study sample [Burrows et al, Differences in Dietary Preferences, Personality and Mental Health in Australian Adults with and without Food Addiction. Nutrients. 2017; 9(3). pii: E285. doi: 10.3390/nu9030285] which investigated food addiction and mental health, who agreed to be recontacted for future studies, will be invited to participate via email.
Minimum age
18 Years
Maximum age
85 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No existing health conditions or conditions which effect dietary intake (e.g. Coeliac; food allergies or intolerances), binge eating disorder, substance use disorder, current smokers, pregnant or lactating women, use of anti-depressant drugs or undergoing steroid treatment, cognitive impairment or mental health condition (e.g. bipolar disorder or psychosis) requiring ongoing psychiatric treatment.


Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To fit within the allocated budget a sample of 20 females was determined for this small pilot study. T-tests and ANOVA, or non-parametric tests if appropriate, will be conducted to examine within subject and between groups differences in pre and post hormone concentrations.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
23/05/2017
Date of last participant enrolment
Anticipated
Actual
23/04/2018
Date of last data collection
Anticipated
Actual
23/04/2018
Sample size
Target
20
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 14401 0
2308 - Newcastle University

Funding & Sponsors
Funding source category [1] 294613 0
University
Name [1] 294613 0
University of Newcastle
Country [1] 294613 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive,
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 301922 0
None
Name [1] 301922 0
Address [1] 301922 0
Country [1] 301922 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296067 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 296067 0
Ethics committee country [1] 296067 0
Australia
Date submitted for ethics approval [1] 296067 0
25/08/2016
Approval date [1] 296067 0
16/09/2016
Ethics approval number [1] 296067 0
H-2016-0305

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

Contacts
Principal investigator
Name 69374 0
A/Prof Tracy Burrows
Address 69374 0
School of Health Sciences
Faculty of Health and Medicine
Priority Research Centre in Physical Activity and Nutrition
University Drive,
Callaghan NSW 2308
Country 69374 0
Australia
Phone 69374 0
+61 2 49215514
Fax 69374 0
+61 2 49217053
Email 69374 0
[email protected]
Contact person for public queries
Name 69375 0
Tracy Burrows
Address 69375 0
School of Health Sciences
Faculty of Health and Medicine
Priority Research Centre in Physical Activity and Nutrition
University Drive,
Callaghan NSW 2308
Country 69375 0
Australia
Phone 69375 0
+61 2 49215514
Fax 69375 0
+61 2 49217053
Email 69375 0
[email protected]
Contact person for scientific queries
Name 69376 0
Tracy Burrows
Address 69376 0
School of Health Sciences
Faculty of Health and Medicine
Priority Research Centre in Physical Activity and Nutrition
University Drive,
Callaghan NSW 2308
Country 69376 0
Australia
Phone 69376 0
+61 2 49215514
Fax 69376 0
+61 2 49217053
Email 69376 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.