ACTRN12623001162606招募中Unknown
Evaluation of two dietary patterns in people with depression: A proof-of-concept trial
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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