Impact of A Low-Carbohydrate, High-Fat, Ketogenic Diet on Obesity, Metabolic Abnormalities and Psychiatric Symptoms in Patients With Bipolar or Schizophrenia Illness: A Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Change in lipid profile (HDL) from baseline
研究概览
简要总结
To initiate a low-carbohydrate, high-fat (LCHF) or ketogenic dietary (KD) intervention among a cohort of outpatients with either schizophrenia or bipolar illness who also have metabolic abnormalities, overweight/obesity, and/or are currently taking psychotropic medications experiencing metabolic side effects.
详细描述
Adults with mental illness represent a high-risk, marginalized group in the current metabolic and obesity epidemic. Among US adults with severe mental illness, metabolic syndrome are highly prevalent conditions having severe consequences, with patients estimated to die on average 25 years earlier than the general population largely of premature cardiovascular disease. Many psychiatric medications, particularly neuroleptics and mood stabilizers, may, in addition, contribute to metabolic side effects and weight gain. Low-carbohydrate high-fat (LCHF) or ketogenic diets (KD) have been shown to reduce cardiovascular risk in those with insulin resistance. Recent findings support the idea that bipolar disorder, along with other psychiatric diseases schizophrenia, may have roots of metabolic dysfunction: cerebral glucose hypometabolism, oxidative stress, as well as mitochondrial and neurotransmitter dysfunction which has downstream effects on synapse connections. A KD diet provides alternative fuel to the brain aside from glucose and is believed to contain beneficial neuroprotective effects, including stabilization of brain networks, reduction of inflammation and oxidative stress. The purpose of this study is to evaluate both the metabolic and psychiatric outcomes with a KD diet in this psychiatric population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years old
- •Meet DSM V criteria for schizophrenia or bipolar disorder, any subtype, for > 1 year and clinically stable (with no hospitalization for past 3 months)
- •Currently taking psychotropic medication and gained at least 5% weight since starting medication or have a BMI greater than or equal to 26 kg/m2 or presence of at least one metabolic abnormality (hypertriglyceridemia, insulin resistance, dyslipidemia, impaired glucose tolerance)
- •Willing to consent to all study procedures and attend follow-up appointments and motivated to follow the dietary program.
- •Sufficient control over their food intake to adhere to study diets.
- •Willingness to regularly monitor blood pressure, glucose, dietary intake, and body weight over the 4-month trial
排除标准
- •Any subject pregnant or nursing
- •Comorbidity of developmental delay
- •Active substance abuse with illicit drugs or alcohol
- •In a current severe mood or psychotic state when entering the study that would prohibit compliance with study visits or dietary program.
- •Anyone who has been hospitalized or taken clozapine over the past 3 months
- •Inability to complete baseline measurements
- •Severe renal or hepatic insufficiency
- •Cardiovascular dysfunction, including diagnosis of:
- •Congestive heart failure
- •Arrhythmias
- •Cardiomyopathy
- •Valvular heart disease
- •Any other medical condition that may make either diet dangerous as determined by the study medical team (e.g. anorexia nervosa)
研究组 & 干预措施
Ketogenic Diet 16 Week Group
Patients follow ketogenic diet for 16 weeks, with monitoring of physical and psychological health and coaching support
干预措施: LCHF, Ketogenic Diet (Other)
结局指标
主要结局
Change in lipid profile (HDL) from baseline
时间窗: Baseline,16 weeks
Lipid profile HDL measured at initial and final visits
Change in heart rate from baseline
时间窗: Baseline, 16 weeks
Heart rate recorded at 9 visits during study
Change in blood pressure from baseline
时间窗: Baseline, 16 weeks
Blood pressure recorded at 9 visits during study
Change in weight from baseline
时间窗: Baseline, 16 weeks
Weight recorded at 9 visits during study
Change in waist circumference from baseline
时间窗: Baseline, 16 weeks
waist circumference measured at 9 visits during study
Change in visceral fat mass from baseline
时间窗: Baseline, 16 weeks
Body composition (SECA) recorded at 5 visits during study
Change in body fat mass from baseline
时间窗: Baseline, 16 weeks
Body composition (SECA) recorded at 5 visits during study
Percent Change in Hemoglobin A1c from baseline
时间窗: Baseline, 16 weeks
Hemoglobin A1c recorded at initial and final visits
Change in insulin resistance measure (HOMA-IR) from baseline
时间窗: Baseline, 16 weeks
HOMA-IR measured at initial and final visits
Change in inflammatory marker (hsCRP) from baseline
时间窗: Baseline, 16 weeks
hsCRP measured at initial and final visits
Change in lipid profile TG (triglycerides) from baseline
时间窗: Baseline, 16 weeks
Lipid profile TG measured at initial and final visits
Change in lipid profile small LDL (small dense LDL) from baseline
时间窗: Baseline, 16 weeks
Lipid profile small LDL measured at initial and final visits
次要结局
- Psychiatric Indices - Mood(Baseline, 16 weeks)
- Psychiatric Indices- Clinical Global Impression(Baseline, 16 weeks)
- Generalized Anxiety Disorder - GAD-7 Anxiety(Baseline, 16 weeks)
- Patient Health Questionnaire - PHQ-9 Depression(Baseline, 16 weeks)
- Psychiatric Indices- Global Assessment of Functioning(Baseline, 16 weeks)
- Psychiatric Indices- Quality of Life(Baseline, 16 weeks)
- Psychiatric Indices- BPRS(Baseline, 16 weeks)
- Pittsburgh Sleep Quality Index - PSQI(Baseline, 16 weeks)
研究者
Shebani Sethi
Clinical Assistant Professor
Stanford University