Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000423314
Ethics application status
Approved
Date submitted
17/03/2017
Date registered
24/03/2017
Date last updated
18/03/2019
Date data sharing statement initially provided
18/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A 3-week diet intervention to improve mood and inflammation in young adults with depressive symptoms
Scientific title
A 3-week diet intervention to improve mood and inflammation in young adults with depressive symptoms
Secondary ID [1] 291411 0
None
Universal Trial Number (UTN)
U1111-1194-0771
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 302429 0
Other inflammatory or immune system disorders 302577 0
Other diet and nutrition disorders 302578 0
Condition category
Condition code
Mental Health 301997 301997 0 0
Depression
Inflammatory and Immune System 302129 302129 0 0
Other inflammatory or immune system disorders
Diet and Nutrition 302130 302130 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be instructed to increase intake of fish, fruits, vegetables, nuts, seeds, natural diary and wholegrain cereals, and decrease refined carbohydrate, sugar, fatty or processed meats and soft-drinks. Recommendations are based on the Australian Guide to Healthy Eating, as well as Mediterranean diet principles known to be associated with improved mood, incorporate BeyondBlue behavioural tips for eating well, and administered by a registered dietician via video and available to re-watch as needed. The video lasts 13 minutes, and provides information on the 5 major food groups in the Australian Guide to Healthy Eating (wholegrains, protein, dairy, fruit, vegetables), as well as recommendations to additionally consume specific foods known for their health benefits (olive oil, avocados, nuts and seeds, and spices). The video was scripted and performed by Jaime Chambers (Accredited Practicing Dietician and Nutritionist). Participants will be provided a sample meal plan and recipes, also compiled by Jaime Chambers, based on the Australian Guide to Healthy Eating, Participants will be provided online access to the diet intervention video and answers to frequently asked questions. The intervention will last 3-weeks, and they will receive weekly telephone call reminders, with a brief survey about their diet intake for the preceding day.
Intervention code [1] 297446 0
Lifestyle
Comparator / control treatment
Diet as usual
Control group
Active

Outcomes
Primary outcome [1] 301420 0
Centre for Epidemiological Studies Depression Scale - Revised
Timepoint [1] 301420 0
3 weeks
Secondary outcome [1] 332584 0
Depression Anxiety and Stress Scale-21 (Depression subscale)
Timepoint [1] 332584 0
3-weeks
Secondary outcome [2] 332585 0
Hopkins Verbal Learning Test
Timepoint [2] 332585 0
3-weeks
Secondary outcome [3] 332586 0
Kynurenic Acid(KA)/Quinolinic Acid (QA) ratio in urine. Quantification of kynurenine pathway metabolites (KA and QA) will be performed by ultra-high performance liquid chromatography (UHPLC) and gas chromatography mass spectrometry (GC-MS),
Timepoint [3] 332586 0
3-weeks
Secondary outcome [4] 332976 0
Depression Anxiety and Stress Scale-21 (Anxiety subscale)
Timepoint [4] 332976 0
3-weeks
Secondary outcome [5] 332977 0
Depression Anxiety and Stress Scale-21 (Stress subscale)
Timepoint [5] 332977 0
3-weeks
Secondary outcome [6] 332978 0
Profile of Mood States
Timepoint [6] 332978 0
3-weeks
Secondary outcome [7] 332979 0
Body Mass Index
Timepoint [7] 332979 0
3-weeks
Secondary outcome [8] 332980 0
Waist circumference
Timepoint [8] 332980 0
3-weeks
Secondary outcome [9] 332981 0
Photospectrometry - a device will be held to the palm of the hand and will take a photo to measure skin colouration, which is a reliable indicator of fruit and vegetable intake.
Timepoint [9] 332981 0
3-weeks
Secondary outcome [10] 332982 0
Sucrose (measured in urine using multiplex assay and performed at the Australian Proteomic Analysis Facility) as an estimate of sugar intake.
Timepoint [10] 332982 0
3-weeks
Secondary outcome [11] 332983 0
Creatinine (measured in urine using multiplex assay and performed at the Australian Proteomic Analysis Facility) as an estimate of protein intake.
Timepoint [11] 332983 0
3-weeks
Secondary outcome [12] 332984 0
Urine samples will be analysed at the Australian Proteomic Analysis Facility using a Bio-Rad 27-plex kit, allowing detection of 27 cytokines, chemokines and growth factors related to inflammation. This is purchased as a standardized assay, but we will be interested in particular cytokines IL-1, IL6 and TNF-alpha.
Timepoint [12] 332984 0
3-weeks

Eligibility
Key inclusion criteria
Elevated (>7) scores on the Depression, Anxiety and Stress Scale-21 Depression subscale (DASS-21-D); Score > 57 on the Dietary Fat and Sugar Screener (DFS).
Minimum age
17 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No history of metabolic, cardiovascular or eating disorders; not pregnant, not currently dieting, no religious or medical factors affecting adherence to diet. If receiving antidepressant medication or therapy, on the same treatment for at least 2 weeks before study participation.

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


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/04/2017
Actual
8/05/2017
Date of last participant enrolment
Anticipated
15/10/2018
Actual
3/09/2018
Date of last data collection
Anticipated
5/11/2018
Actual
24/09/2018
Sample size
Target
84
Accrual to date
Final
78
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 295882 0
Charities/Societies/Foundations
Name [1] 295882 0
Society for Mental Health Research
Country [1] 295882 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Macquarie University, NSW 2109, Australia
Country
Australia
Secondary sponsor category [1] 294828 0
None
Name [1] 294828 0
Address [1] 294828 0
Country [1] 294828 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297161 0
Macquarie University Human Ethics Committee
Ethics committee address [1] 297161 0
Ethics committee country [1] 297161 0
Date submitted for ethics approval [1] 297161 0
14/02/2017
Approval date [1] 297161 0
27/04/2017
Ethics approval number [1] 297161 0

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

Contacts
Principal investigator
Name 73186 0
Dr Heather Francis
Address 73186 0
Psychology Department, Macquarie University, North Ryde 2109 NSW
Country 73186 0
Australia
Phone 73186 0
+61 2 9850 4081
Fax 73186 0
Email 73186 0
[email protected]
Contact person for public queries
Name 73187 0
Heather Francis
Address 73187 0
Psychology Department, Macquarie University, North Ryde 2109 NSW
Country 73187 0
Australia
Phone 73187 0
+61 2 9850 4081
Fax 73187 0
Email 73187 0
[email protected]
Contact person for scientific queries
Name 73188 0
Heather Francis
Address 73188 0
Psychology Department, Macquarie University, North Ryde 2109 NSW
Country 73188 0
Australia
Phone 73188 0
+61 2 9850 4081
Fax 73188 0
Email 73188 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
This was not requested as part of the ethics application.


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.