NCT03901183已完成不适用
Plant-based Nutrition for Patients With Cardiovascular Risk Factors - a Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 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
研究组 & 干预措施
Interventional
Experimental
Participants receive a 8 week nutritional counseling with weekly group meetings to establish a plant-based diet.
干预措施: Plant-based Diet (Other)
Control
No Intervention
Waiting list. Participants receive no intervention during study period, equal intervention is offered after the end of 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
- Wrist Circumference (cm)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Medication intake(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)
- 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)
- 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)
- Flourishing Scale (FS-D)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Waist 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)
- 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 (1)
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