ACTRN12623000854639尚未招募Unknown
The effects of diet on metabolic and mental health outcome measures in bipolar disorder and schizophrenia: a randomized controlled clinical trial
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 100
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 o limit（—）
- 性别
- All
入选标准
- •1) Meet the DSM-4 diagnostic criteria for bipolar disorder or meet the DSM-5 diagnostic criteria for schizophrenia for at least 6 months, assessed using the MINI Neuropsychiatric Interview
- •2) Clinically stable is defined as 3 months with no relapses.
- •3) Able to provide informed consent to take part in the study.
- •4) Able to speak, read and understand English to a level whereby they can understand the participant information sheet (PIS).
- •5) Able to understand basic principles of the specific diet
- •6) Ability to complete an accurate diet and symptom diary as well as questionnaires required.
排除标准
- •1) Pregnancy or breastfeeding (or those planning to become pregnant within 3 months)
- •2) Active substance misuse with alcohol or illicit drugs
- •3) Use of the ketogenic diet in the previous 2 months
- •4) Currently following a vegan diet
- •5) Admission to a hospital within the past 3 months
- •6) Current involvement in another research study (This feasibility study is of moderate intensity and requires daily monitoring and a significant dietary intervention requiring careful planning. As such it would not be appropriate for participants involved in other current research to take part due to the potentially high level of burden on them. Those involved in recent research that has ended by the time of recruitment to this study would be eligible, and will be made fully aware of the level of engagement required to allow them to make an informed decision)
- •7) Inability to complete week 0 assessments
- •8) Clinically significant liver or kidney disease
- •9) Clinically significant cardiovascular disease
- •10) Severe hyperlipidemia
- •11) Type 1 diabetes
- •12) History of eating disorder
- •13) BMI < 18.5kg
- •14) On medication that can cause ketosis
- •15) Not willing to change diet or unable to change diet due to medical reasons
- •16) No access to cooking facilities and ingredients to prepare recipes following the specific diet.
研究者
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