Modulation of Cardiovascular Risk II (MoKaRi II) Intervention Study - Modulation of Cardiovascular Risk and Diabetes Risk Using Menu Plans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Triacylglcerides, mmol/l (group A, B)
研究概览
简要总结
The proposed intervention study addresses the development and validation of nutritional concepts based on menu plans for patients with hypertriglyceridemia (triglycerides > 1.5 mmol/l) and participants with impaired glucose tolerance/prediabetes (glucose > 5.6 ≤ 7 mmol/l).
详细描述
The proposed intervention study addresses the development and validation of nutritional concepts for patients with hypertriglyceridemia (triglycerides > 1.5 mmol/l) and participants with impaired glucose tolerance (glucose > 5.6 ≤ 7 mmol/l).
The randomized, controlled study will be conducted in a parallel design with four arms. In total, 120 participants (males, females; age: 30 - 80 years) will be randomized to one of the four groups: hypertriglyceridemia concept (group A), hypertriglyceridemia control (group B), prediabetes concept (group C), and prediabetes control (group D).
The study participants in group A and C receive defined personal nutritional counselling every two weeks and they are provided with daily menu plans (isocaloric) with optimized nutrient profiles and chosen study products (e.g., fish or plant oil, nuts) over the study period of ten weeks. Participants in the control groups B and D are not provided with defined menu plans or study products.
Blood samples will be taken at the beginning, regularly every two weeks of the ten-weeks intervention period as well as after the ten-weeks follow-up. Primary endpoints are triglycerides (group A, B), and fasting glucose (group C, D).
The study design enables the comparison of the effectiveness of the developed nutritional concepts, which were adapted to the requirements of the target groups.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntary participation with documented consent
- •Willingness and ability to adhere to study protocol
- •Volunteer test person (m/f) aged ≥ 30 years and ≤ 80 years
- •BMI: ≥ 20 ≤ 40 kg/m2
- •No or moderate alcohol consumption (≤ 2 glasses/week)
- •non-smoker (if possible)
- •Group A, B: triglycerides: > 1.5 mmol/l
- •Group C, D: Fasting glucose: ≥ 5.6 ≤ 7 mmol/L
排除标准
- •Concomitant diseases:
- •Hypercholesterolemia (genetic defect / familial predisposition)
- •Diabetes mellitus
- •Thyroid dysfunction (hyper- or hypothyroidism)
- •Food intolerances/allergies to ingredients in the study foods
- •Medications: lipid-lowering drugs, glucocorticoids, oral medication for the treatment of type 1-4 diabetes mellitus, insulin injections
- •Dietary supplements: especially n-3 fatty acids, vitamin E
- •Extremely high physical activity (daily)
- •Alcohol abuse (daily)
- •(smokers) [if there are not enough subjects available, at least 7 smokers should be included so that a statistical analysis is possible]
- •Uncontrolled organic diseases
- •Alcohol, medication or drug abuse
- •Participation in other observational clinical studies during or 4 wk. before starting this study
- •Severe behavioral, emotional, or psychiatric problems that the investigator determined would result in non-compliance
- •Pregnancy, lactation and unsafe contraception
- •Other reasons considered important by the investigator
结局指标
主要结局
Triacylglcerides, mmol/l (group A, B)
时间窗: Change from baseline after 10 weeks
Cardiovascular risk factor
Fasting glucose, mmol/l (group C, D)
时间窗: Change from baseline after 10 weeks
Diabetes risk factor
次要结局
- High sensitive c-reactive protein (mg/l)(Change from baseline after 10 weeks)
- Vitamin B6 (nmol/l)(Change from baseline after 10 weeks)
- Vitamin B12 (pmol/l)(Change from baseline after 10 weeks)
- Selenium (µmol/l)(Change from baseline after 10 weeks)
- Total cholesterol (mmol/l)(Change from baseline after 10 weeks)
- Diastolic pressure (mm Hg)(Change from baseline after 10 weeks)
- Vitamin A (mmol/l)(Change from baseline after 10 weeks)
- Vitamin B1 (nmol/l)(Change from baseline after 10 weeks)
- Vitamin H (ng/l)(Change from baseline after 10 weeks)
- HDL cholesterol (mmol/l)(Change from baseline after 10 weeks)
- Systolic pressure (mm Hg)(Change from baseline after 10 weeks)
- Insulin (mU/l)(Change from baseline after 10 weeks)
- LDL cholesterol (mmol/l)(Change from baseline after 10 weeks)
- Folic acid (µg/l)(Change from baseline after 10 weeks)
- HbA1c (%)(Change from baseline after 10 weeks)
- Body fat (kg)(Change from baseline after 10 weeks)
- Fatty acid distribution in erythrocyte lipids (% fatty acid methyl esters)(Change from baseline after 10 weeks)
- Vitamin C (mg/l)(Change from baseline after 10 weeks)
- Body weight (kg)(Change from baseline after 10 weeks)
- Vitamin D (nmol/l)(Change from baseline after 10 weeks)
- Vitamin E (µmol/l)(Change from baseline after 10 weeks)
- Holo-transcobalamin (pmol/l)(Change from baseline after 10 weeks)
- Potassium (mmol/l)(Change from baseline after 10 weeks)
- Iron (µmol/l)(Change from baseline after 10 weeks)
- Ferritin (µg/l)(Change from baseline after 10 weeks)
- Transferrin (g/l)(Change from baseline after 10 weeks)
- Iodine (µmol/l)(Change from baseline after 10 weeks)
- Zinc (µmol/l)(Change from baseline after 10 weeks)
研究者
Christine Dawczynski,PhD
PhD
University of Jena