None listed
Conditions
Brief summary
The AMMEND study is a 3-month randomised control trial testing the effect of a Mediterranean diet (MD) on the symptoms of depression in young men. Participants will be randomly allocated to either the MD group or the control group, which consists of a social support “befriending” protocol, via a computer-generated block randomisation sequence. At the baseline appointment participants will complete a number of questionnaires and baseline measurements which will be recorded in the Case Report Form, including the Becks Depression Inventory depression scale and a short Dietary Screener Questionnaire (DSQ). Participants will have scheduled follow up appointments at 6 weeks and 12 weeks. Participants in the MD group will complete Diet History Forms to check levels of adherence to the diet and will be scored against the MD Adherence Score. The main outcome measure will be any changes to the BDI depression scale results. At the conclusion of the trial, participants in the MD group will complete a short, electronic, self-administered survey assessing their experiences and perceived benefits and challenges of continuing to follow a Mediterranean diet long term.
Interventions
Participants will be allocated to either follow a Mediterranean Diet (MD) or Social support for 12 weeks. Participants will continue with there current medications and/or psychology appointments. A Mediterranean diet is high in wholegrains, fruits and vegetables, legumes, nuts and seeds and plenty of olive oil, it is low in processed or “fast foods” and high sugar snack foods and beverages. Participants in the MD group will follow the diet for all meals and snacks for 12 weeks. Participants will
Participants will be allocated to either follow a Mediterranean Diet (MD) or Social support for 12 weeks. Participants will continue with there current medications and/or psychology appointments. A Mediterranean diet is high in wholegrains, fruits and vegetables, legumes, nuts and seeds and plenty of olive oil, it is low in processed or “fast foods” and high sugar snack foods and beverages. Participants in the MD group will follow the diet for all meals and snacks for 12 weeks. Participants will be provided with a food hamper at the beginning of the trial which included diet staples such as olive oil, nuts and vegetables to get them started and will then buy and cook their own food. They will be provided with comprehensive handouts designed specifically for this study including diet guidelines, meal ideas and example diet plan. The diet will be administered by a qualified nutritionist who participants will meet with at baseline (week 0), week 6 and week 12 for 1 hour. Diet adherence will be monitored by an online food diary (created on surveygizmo for the purpose of this study) which is reported daily.
Sponsors
University of Technology Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
The study population will consist of: 1. Young men aged 18-25 2. Diagnosed with depression by GP or psychologist 3. Received a “poor” diet score (<40) on the CSIRO Healthy diet score survey.
Exclusion criteria
Exclusion Criteria 1. If they can’t speak or understand English 2. If they are not capable of understanding or consenting what is involved with this trail 3. If they are also diagnosed with any of the following mental health disorders: Bipolar disorder, post-traumatic stress, personality disorders, eating disorders, psychotic disorders such as schizophrenia or a substance abuse disorder such as alcoholism. 4. If they have any food allergies, intolerances or eversions (avoiding foods based on religious or ethical grounds). 5. If they are unavailable to attend the scheduled follow up appointment. 6. If they are unwilling to change their diet if allocated to the Mediterranean diet group.
Outcome results
None listed