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Trial registered on ANZCTR


Registration number
ACTRN12614000438651
Ethics application status
Approved
Date submitted
11/04/2014
Date registered
23/04/2014
Date last updated
16/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a Mediterranean-style diet and fish oil supplements on mood and health
Scientific title
Investigating the effects of a Mediterranean-style diet and fish oil supplement intervention on lifestyle behaviour change and on mental and cardiometabolic health in people with self-reported depressive symptoms: A 6-month randomised controlled trial
Secondary ID [1] 284427 0
None
Universal Trial Number (UTN)
U1111-1155-6582
Trial acronym
HELFIMED (Healthy Eating for Life with a Mediterranean-style diet) Mood Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mood/depressive symptoms 291628 0
Cardiometabolic Health 291629 0
Behaviour change 291632 0
Condition category
Condition code
Mental Health 292008 292008 0 0
Depression
Cardiovascular 292009 292009 0 0
Coronary heart disease
Diet and Nutrition 292012 292012 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly allocated to an intervention or control condition.
The intervention group will receive fortnightly food hampers (containing extra virgin olive oil, seasonal fruit/vegetables - approx 2 fruits and 5 vegetables - and nuts) plus 2-hour fortnightly cooking workshops (using selected simple tasty affordable recipes based on Mediterranean diet principles) for 3 months. They will receive fish oil capsules (2/day containing a total of 1g DHA+EPA) for 6 months, commencing at baseline. They will also receive a 2-hour group nutrition education session following baseline assessments designed in consultation with a dietitian and delivered by nutritionists, and recipe folders containing simple healthy tasty affordable meals based on Mediterranean-style dietary principles. Compliance will be measured by 3-day food diaries (at 3 and 6 months), return of fish oil capsule containers and PUFA blood sample analysis.
Intervention code [1] 289177 0
Lifestyle
Intervention code [2] 289210 0
Behaviour
Intervention code [3] 289211 0
Treatment: Other
Comparator / control treatment
The control group will attend fortnightly social groups for 3 months as a control for the cooking workshops. They will receive 3 months supply of fish oil and health information/recipes at the end of the study.
Control group
Placebo

Outcomes
Primary outcome [1] 291899 0
Depression Anxiety Stress Scale (DASS) 21
Timepoint [1] 291899 0
Baseline, 3 months, 6 months
Primary outcome [2] 291900 0
Apolipoprotein B/A1 ratio in serum
Timepoint [2] 291900 0
Baseline, 3 months, 6 months
Primary outcome [3] 291901 0
AQoL-8d Quality of life questionnaire
Timepoint [3] 291901 0
Baseline, 3 months, 6 months
Secondary outcome [1] 307768 0
Sodium/potassium ratio in urine
Timepoint [1] 307768 0
Baseline, 3 months, 6 months
Secondary outcome [2] 307769 0
Blood pressure using an automatic sphygmomanometer, seated after 5 minutes rest
Timepoint [2] 307769 0
Baseline, 3 months, 6 months
Secondary outcome [3] 307770 0
20 item Positive And Negative Affect Scale (PANAS)
Timepoint [3] 307770 0
Baseline, 3 months, 6 months
Secondary outcome [4] 307771 0
14-item Mediterranean diet questionnaire
Timepoint [4] 307771 0
Baseline, 3 months, 6 months
Secondary outcome [5] 307772 0
Simple Dietary Questionnaire (SDQ)
Timepoint [5] 307772 0
Baseline, 3 months, 6 months
Secondary outcome [6] 307773 0
3-day food diaries to measure dietary intake at food group level
Timepoint [6] 307773 0
Baseline, 3 months, 6 months
Secondary outcome [7] 307774 0
Erythrocyte fatty acid analysis in red blood cells
Timepoint [7] 307774 0
Baseline, 3 months, 6 months
Secondary outcome [8] 307775 0
Fasting glucose and insulin in serum
Timepoint [8] 307775 0
Baseline, 3 months, 6 months
Secondary outcome [9] 307776 0
Carotenoids in plasma
Timepoint [9] 307776 0
Baseline, 3 months, 6 months
Secondary outcome [10] 307777 0
Inflammatory markers IL1b, IL6, IL8, IL10, TNF, IL18, MIC-1 and oxidative stress markers reduced glutathione and oxidised glutathione - all in serum
Timepoint [10] 307777 0
Baseline, 3 months, 6 months
Secondary outcome [11] 307891 0
Anthropometric measures (weight, height, waist and hip circumference) using ISAK protocols as per the International Standards for Anthropometric Assesment protocols
Timepoint [11] 307891 0
Baseline, 3 months, 6 months

Eligibility
Key inclusion criteria
Diet quality score indicative of poor diet, adapted from previous scores.
Self-reported depressive symptoms.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently undertaking any other research
Currently taking any fish oil supplements or any in the past 2 months.
Pregnancy
Commencement of new psychotherapy or pharmacotherapy within the preceding fortnight
Severe food allergies, intolerances or aversions
Current participation in an intervention targeting diet or exercise
Primary clinical diagnosis of a personality disorder
A current substance use disorder.

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)
Interested people will call us and be screened by phone for inclusion criteria (including the diet screening tool) then sent information sheet and consent form. After signing the consent form they will be randomly allocated by an independent party to the intervention or control condition and advised of their allocation at the end of their first visit. Allocation will be concealed from the researchers who screen participants and conduct the baseline assessments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be done using the process of minimisation, blocked on age and gender.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
According to Cohen's power analysis we need 60 per group to detect a medium effect size with 80% power.
Linear mixed modelling will be used to test effect of intervention on primary and relevant secondary outcomes, controlling for any confounders identified in the background questionnaire; regression analysis will be used to investigate correlations between changes in biomarkers and outcome variables.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 7987 0
5000 - Adelaide
Recruitment postcode(s) [2] 7988 0
5098 - Walkley Heights

Funding & Sponsors
Funding source category [1] 289078 0
University
Name [1] 289078 0
University of South Australia
Address [1] 289078 0
GPO Box 2471
Adelaide SA 5001
Country [1] 289078 0
Australia
Funding source category [2] 289079 0
Commercial sector/Industry
Name [2] 289079 0
Pathway International (in-kind supply of fish oil capsules from Epax)
Address [2] 289079 0
PO Box 6185, Frenchs Forest, NSW 2086
Country [2] 289079 0
Australia
Funding source category [3] 292384 0
Commercial sector/Industry
Name [3] 292384 0
Simplot (Edgell, John West) - in-kind supply of tinned legumes and tuna
Address [3] 292384 0
Chifley Business Park
2 Chifley Drive Mentone Victoria 3194
Australia
Country [3] 292384 0
Australia
Funding source category [4] 292385 0
Commercial sector/Industry
Name [4] 292385 0
Cobram Estate - in-kind supply of extra virgin olive oil
Address [4] 292385 0
Cobram Estate Pty Ltd
Unit 14, 75 Lorimer Street
Southbank VIC 3006 Australia
Country [4] 292385 0
Australia
Funding source category [5] 292386 0
Government body
Name [5] 292386 0
National Health and Medical Research Council Program Grant
Address [5] 292386 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [5] 292386 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 287741 0
None
Name [1] 287741 0
N/A
Address [1] 287741 0
N/A
Country [1] 287741 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290868 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 290868 0
University of South Australia
GPO Box 2471
Adelaide SA 5001
Ethics committee country [1] 290868 0
Australia
Date submitted for ethics approval [1] 290868 0
Approval date [1] 290868 0
09/04/2014
Ethics approval number [1] 290868 0
0000032674

Summary
Brief summary
This project aims to investigate (1) the effectiveness of the HELFIMED protocol for improving dietary behaviours and nutrition status of people with self-reported depression; (2) the mental health benefits of improved diet/nutrition status and (3) the cardiometabolic benefits of improved diet/nutrition status.
Trial website
http://helfimed.org/moodstudy
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47682 0
Dr Natalie Parletta
Address 47682 0
School of Population Health
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 47682 0
Australia
Phone 47682 0
+61 8 8302 1757
Fax 47682 0
Email 47682 0
natalie.parletta@unisa.edu.au
Contact person for public queries
Name 47683 0
Dr Dorota Zarnowiecki
Address 47683 0
School of Population Health
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 47683 0
Australia
Phone 47683 0
+61 8 8302 2390
Fax 47683 0
Email 47683 0
dorota.zarnowiecki@unisa.edu.au
Contact person for scientific queries
Name 47684 0
Dr Natalie Parletta
Address 47684 0
School of Population Health
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 47684 0
Australia
Phone 47684 0
+61 8 8302 1757
Fax 47684 0
Email 47684 0
natalie.parletta@unisa.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary