Düsseldorf Bread Study on Health Effects of Bread.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- body weight
研究概览
简要总结
The hypothesis is to be tested that eating carbohydrate-reduced bread over three months leads to a significant weight difference compared to conventional, carbohydrate-rich bread.
详细描述
Carbohydrate reduction is an important element for weight loss or can also be used to keep weight constant. Since the majority of the carbohydrates consumed daily in industrialized countries come from bread and rolls, the present study will examine the effect of two different types of bread on the weight development of overweight bread consumers. The two types of bread differ in their carbohydrate content and the hypothesis is to be tested that eating carbohydrate-reduced bread over three months leads to a significant weight difference compared to conventional, carbohydrate-rich bread. The comparison of the two types of bread is carried out triple blinded. During two visits (before and after the bread consumption phase), the health status is determined with physical parameters and laboratory parameters from a blood test. The primary endpoint is body weight. Overall, this study will for the first time allow extensive statements to be made on the health value of the three-month consumption of two different types of bread.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •body mass index of at least 27 kg/m2
排除标准
- •serious illness with hospitalization in the last 3 months
- •Changes in body weight (estimated weekly average) by more than 2 kg in the past 4 weeks
- •Non-smoking status for less than 3 months
- •Change of smoking habits planned during the study
- •acute diseases such as respiratory or gastrointestinal infections
- •Chronic diseases, e.g. Tumor diseases, chronic obstructive pulmonary disease (COPD), asthma, dementia, intestinal diseases, diabetes
- •regular use of medication (except contraceptives) such as Lipid lowering, blood pressure lowering, weight-regulating medication, aspirin
- •no contraception in women of childbearing age or breastfeeding a child
- •high sporting activity (≥ 1 hour per day)
- •planned absence of> 7 days during the intervention phase
结局指标
主要结局
body weight
时间窗: 3 months
change of body weight in kg
次要结局
- waist circumference(3 months)
- high-density lipoprotein (HDL) cholesterol(3 months)
- low-density lipoprotein (HDL) cholesterol(3 months)
- body mass index(3 months)
- total cholesterol(3 months)
- hip circumference(3 months)
- blood pressure(3 months)
- hemoglobin A1c (HbA1C)(3 months)
- fasting blood glucose(3 months)
- waist-to-height-index(3 months)
- triglycerides(3 months)
- fasting blood insulin(3 months)
- homeostasis model assessment of insulin resistance (HOMA-IR)(3 months)
- height(at baseline)
研究者
Stephan Martin
director
West German Center of Diabetes and Health