Evaluation of a dietary pattern in healthy volunteers: A proof-of-concept trial
- Conditions
- DepressionMental Health - Depression
- Registration Number
- ACTRN12624000108516
- Lead Sponsor
- Deakin University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 22
•Adults aged 18-65 years
•Poor quality diet (as rated by an adapted Total Diet Score)
•Willing to undertake and adhere to a 4-week feeding trial (willing to consume study meals provided) 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)
•Must nominate a preferred general practitioner
•Mild, moderate or severe depressive symptoms based on score greater than or equal to 7 on MADRS
•Participants with current suicidal ideation with a specific plan, defined as a score of 5 or 6 on the MADRs item 10
•Current clinician-diagnosed major depressive disorder reported by participant or requiring medication and/or other treatment for depression
•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, colectomy)
•Clinician-diagnosed irritable bowel syndrome or inflammatory bowel disease reported by participant
•Clinician-diagnosed 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 standard drinks/week)
•Clinician diagnosed eating disorder reported by participant or score greater than or equal to 3 on the SCOFF eating disorder screening questionnaire or history of purging, binge eating or laxative abuse
•Dietary restrictions, food allergies, intolerances or aversions, that would interfere with consuming intervention foods (I.e., food allergy coeliac disease, veganism, lacto-ovo vegetarianism)
•Sociocultural, religious, medical reasons which precludes 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%) (as energy intake requirements will be more difficult to achieve)
•Current participation in another clinical trial
•Probiotic, prebiotic and/or synbiotic supplementation in the past 4 weeks
•Antibiotic use in the past 4 weeks
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinician-rated depressive symptoms.[ Montgomery-Asberg Depression Rating Scale (MADRS). Baseline and week 4 post-diet commencement.<br>]
- Secondary Outcome Measures
Name Time Method