Evaluation of two dietary patterns in people with depression: A proof-of-concept trial
- Conditions
- Major depressive disorderMental Health - Depression
- Registration Number
- ACTRN12623001162606
- Lead Sponsor
- Deakin University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 44
• Adults aged 18-65 years
• Successfully fulfilled the Diagnostic and Statistical manual of Mental Disorders (DSM-5) diagnostic criteria for a major depressive episode, determined using the SCID-5-RV
• Moderate or severe depressive symptoms based on score equal to or greater than 20 on MADRS
• Poor diet quality (based on an adapted Total Diet Score)
• Willing and able to undertake and adhere to the requirements of a 4-week feeding trial and attend all study appointments
• Reside in meal delivery zones
• Must be able to read and understand materials written in English
• Have access to a smartphone/tablet/computer with internet access and kitchen facilities (e.g., microwave/oven, freezer)
• Have a nominated preferred general practitioner
• Diagnosis of complex medical disorder (e.g., cancer, type 1 and 2 diabetes, dementia, heart failure, chronic obstructive pulmonary disease)
• History of major GI surgery (e.g., gastrectomy, any GI resection, colectomy)
• Clinician-diagnosed irritable bowel syndrome or inflammatory bowel disease reported by participant
• Comorbid psychiatric diagnosis by clinician of bipolar I or II disorder, psychotic disorder or personality disorder reported by participant
• Clinician diagnosed substance use disorder reported by participant and/or excess alcohol intake (>10 standard drinks per week or >4 standard drinks on any one day)
• Clinician diagnosed eating disorder reported by participant or score equal to or greater than 3 on the SCOFF eating disorder screening questionnaire or history of purging, binge eating or laxative abuse
• Two or more failed trials of antidepressant therapy for the current major depressive episode
• Dietary restrictions, food allergies, intolerances or aversions, that would interfere with consuming intervention foods (e.g., food allergy, coeliac disease, veganism, lacto-ovo vegetarianism)
• Sociocultural, religious or medical reasons which preclude participation
• Females who report to be pregnant or breastfeeding
• Individuals who exceed the minimal physical activity guidelines of 150 min/wk or underweight (BMI <18.5 kg/m2) or class III obesity (>40 kg/m2) or unstable weight (loss/gain) over the past 3 months (> 5%)
• Current participation in another clinical trial
• Probiotic, prebiotic and/or synbiotic supplementation in the past 4 weeks
• Antibiotic use in the past 4 weeks
• For participants currently prescribed antidepressant or psychotherapy: change in antidepressant therapy and/or psychotherapy in the 4 weeks prior to randomisation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinician-rated depressive symptoms assessed using the Montgomery-Asberg Depression Rating Scale (MADRS).[ Baseline and week 4 post-diet commencement. ]
- Secondary Outcome Measures
Name Time Method