NCT03901183已完成不适用
Plant-based Nutrition for Patients With Cardiovascular Risk Factors - a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change of baseline Composite Score for Metabolic Syndrom (Standardizing Physiological Composite Risk Endpoints (SCORE)) at 2 months
研究概览
简要总结
Plant-based nutrition may have positive effects on chronic diseases such as cardiovascular or metabolic disorders. This study investigates the effects of a 8 week plant-based diet for patients with metabolic syndrom and cardiovascular risk factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Blood pressure > 140 mmHg systolic and/or > 90 mmHg diastolic, in case of medication also increased values > 140 mmHg systolic and/or > 90 mmHg diastolic needed
- •Adipositas with a waist circumference of > 94 cm in men and > 80 cm in women
- •A non-vegetarian diet in the past 6 months (at least 4x meat and/or meat products per week, at least 5x dairy products per week)
- •No fasting, no specific diet or change of diet in the last 2 months
- •Weight stable over the last two months (+- 3 kg)
- •Medication unchanged for at least one month
- •No fasting, no change of diet in the last 2 months
排除标准
- •Poor general condition
- •Coronary heart disease
- •Diabetes mellitus Type I
- •Cerebrovascular diseases
- •Severe mental illness
- •Severe acute or chronic comorbidity
- •Pregnancy and lactation or planned pregnancy in the next 6 months
- •Eating disorder
- •Max. 2 beers 0,5l or 2 wines 0,2l per day
- •No alcohol abstinence 48 hours before blood samples possible
- •Max. 5 cigarettes/day
- •Medicine that affect weight
- •Antibiotics within the last 6 months
- •Major surgery <6 months prior to randomization
- •BMI > 40 kg/m2
- •Existing vegetarian or plant-based diet
- •Bariatric surgery (obesity surgery)
- •Simultaneous participation in another clinical trial
- •Participation in a clinical trial within the last 3 months prior to inclusion in the study
- •Lack of consent to participate in the study
结局指标
主要结局
Change of baseline Composite Score for Metabolic Syndrom (Standardizing Physiological Composite Risk Endpoints (SCORE)) at 2 months
时间窗: Date of inclusion (baseline), after 8 weeks
Composite score including waist wircumference, blood pressure, fasting blood glucose, tryglycerids, HDL-cholesterin Range 0-100, lower score meaning a better outcome
次要结局
- Bio-electrical Impedance Analysis (BIA)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Change from baseline systolic blood pressure at 2 months(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Blood lipids(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Ferritin (µg/l)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Holotranscobalamin (pmol/L)(Date of inclusion (baseline), after 16 weeks)
- Quality of Life questionnaire (WHO-5)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- General Self-efficacy Short Scale (ASKU)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Body Mass Index (kg/m2)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Bio-electrical Impedance analysis (BIA)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Fructosamin (µmol/l)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Liver enzymes(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Folic acid (ng/ml)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Complete Blood Count(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Trimethylamine N-oxide (mg/dl)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Change from baseline diastolic blood pressure at 2 months(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Fasting glucose (mmol/l)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Glycated hemoglobin (HbA1c) (%)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Uric Acid (mg/dl)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Stress questionnaire (Cohen Perceived Stress Scale, CPSS)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Waist circumference (cm)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Flourishing Scale (FS-D)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Insulin (µU/ml)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Homeostatic model assessment (HOMA-IR)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Zerssen symptom list (B-LR and B-LR')(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Wrist Circumference (cm)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Ambulatory Blood Pressure Monitoring (ABPM)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Hospital Anxiety and Depression Scale (HADS)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Medical Outcomes Study Short Form (MOS SF-12)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Intuitive Eating Scale 2 (IES-2)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- International Physical Activity Questionnaire (IPAQ )(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Medication intake(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Gut microbiome(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Blood Oxygenization(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Body weight (kg)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Daily nutrition protocol(Daily throughout the entire survey period)
- Dietary Behaviour(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Heart Rate (HR)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Heart Rate Variability (HRV)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Number of Steps per 24 hours(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Evaluation of inflammatory oral conditions(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Evaluation of teeth related conditions(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Evaluation of Oral Fluids(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Evaluation of periodontal status(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Cardio Vascular Risc Profile(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Skin Temperature(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Interbeat Interval (IBI)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Blood Volume Pulse(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Electrodermal Activity (Galvanic Skin Response)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Respiration Rate(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Sociodemographic Measurements(Date of inclusion (baseline))
- Oral Health Qualitative Interviews(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Evaluation of periodontal attachment level(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Evaluation of oral hygiene(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
研究者
Andreas Michalsen
Prof. Dr. med.
Charite University, Berlin, Germany
研究点 (2)
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