None listed
Conditions
Brief summary
OPTIMISM is a 4-week double-blind placebo-controlled feeding trial in 44 adults with a major depressive disorder. The study aims to investigate the effect of two dietary patterns on depressive symptoms, other psychological endpoints and various biological endpoints to understand potential mechanisms. All meals and snacks will be provided to participants for the duration of the study. Study visits will be conducted at baseline and week 4 at either the Health Education and Research Building (HERB), Barwon Health, Geelong, or at the Alfred Centre, Monash University, Melbourne.
Interventions
Participants will attend study visits in-clinic at baseline and week 4 at either the Health Education and Research Building (HERB), Barwon Health, Geelong or at the Alfred Centre, Monash University, Melbourne. A whole-diet intervention that provides a balance of protein, carbohydrate and fat will be provided to participants for 4 weeks. A 7-day meal plan, which meets the food group targets of the intervention diet, was developed for two energy levels (Level 1 - 8MJ/day, Level 2 - 10MJ/day). Part
Participants will attend study visits in-clinic at baseline and week 4 at either the Health Education and Research Building (HERB), Barwon Health, Geelong or at the Alfred Centre, Monash University, Melbourne. A whole-diet intervention that provides a balance of protein, carbohydrate and fat will be provided to participants for 4 weeks. A 7-day meal plan, which meets the food group targets of the intervention diet, was developed for two energy levels (Level 1 - 8MJ/day, Level 2 - 10MJ/day). Participants will be allocated to Level 1 or Level 2 based on an assessment of their habitual diet at baseline by a dietitian and may be adjusted at subsequent weekly calls to meet an individual’s energy requirements, based on dietetic assessment (e.g. assessment of individual’s weight, hunger levels). Three meals and three snacks will be provided to participants for the duration of the study. Participants will receive dietary information one-on-one from a dietitian at baseline and will be provided with a study booklet developed for the purpose of the study. One-on-one baseline and week 4 visits will be approximately 2 hours in duration each. During the intervention, participants will meet weekly with a study investigator (dietitian) online which will be approximately 20 minutes in duration. Diet adherence will be assessed via the completion of daily food adherence logs which will be returned to researchers at the final study visit.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Outcome results
None listed