Düsseldorf Bread Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Düsseldorf Bread Study on Health Effects of Bread.

Conditions
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Body Weight

Intervention / Treatment
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* Other: carbohydrate reduced bread
* Other: carbohydrate rich bread


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - body mass index of at least 27 kg/m2 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: carbohydrate rich bread<br> | Other: carbohydrate rich bread<br>* Consumption of carbohydrate rich bread for three months.<br>|
| Experimental: carbohydrate reduced bread<br> | Other: carbohydrate reduced bread<br>* Consumption of carbohydrate reduced bread for three months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight | change of body weight in kg | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body mass index | change of body mass index in kg/m*m (body weight and height will be combined to report body mass index) | 3 months | 
| waist circumference | change of weight circumference in cm | 3 months | 
| waist-to-height-index | change of waist-to-height-index (waist circumference and height will be combined to report waist-to-height-index) | 3 months | 
| hip circumference | change of hip circumference in cm | 3 months | 
| blood pressure | change of blood pressure in mmHg | 3 months | 
| triglycerides | change of triglycerides in mg/dl | 3 months | 
| total cholesterol | change of total cholesterol in mg/dl | 3 months | 
| high-density lipoprotein (HDL) cholesterol | change of high-density lipoprotein (HDL) cholesterol in mg/dl | 3 months | 
| low-density lipoprotein (HDL) cholesterol | change of low-density lipoprotein (HDL) cholesterol in mg/dl | 3 months | 
| hemoglobin A1c (HbA1C) | change of hemoglobin A1c (HbA1C) in % | 3 months | 
| fasting blood glucose | change of fasting blood glucose in mg/dl | 3 months | 
| fasting blood insulin | change of fasting blood insulin µU/ml | 3 months | 
| homeostasis model assessment of insulin resistance (HOMA-IR) | change of homeostasis model assessment of insulin resistance (HOMA-IR) (fasting blood glucose and fasting blood insulin will be combined to report HOMA-IR) | 3 months | 
| height | height in cm | at baseline |