West German Centre of Diabetes and Health
Düsseldorf, 40591, Germany
NCT Number: NCT04248673
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.
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Notify Me18 year–69 year
All sexes
Interventional
Not applicable
Düsseldorf, 40591, Germany
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Consumption of carbohydrate reduced bread for three months.
Consumption of carbohydrate rich bread for three months.
Time frame: 3 months
change of body weight in kg
Time frame: 3 months
change of body mass index in kg/m*m (body weight and height will be combined to report body mass index)
Time frame: 3 months
change of weight circumference in cm
Time frame: 3 months
change of waist-to-height-index (waist circumference and height will be combined to report waist-to-height-index)
Time frame: 3 months
change of hip circumference in cm
Time frame: 3 months
change of blood pressure in mmHg
Time frame: 3 months
change of triglycerides in mg/dl
Time frame: 3 months
change of total cholesterol in mg/dl
Time frame: 3 months
change of high-density lipoprotein (HDL) cholesterol in mg/dl
Time frame: 3 months
change of low-density lipoprotein (HDL) cholesterol in mg/dl
Time frame: 3 months
change of hemoglobin A1c (HbA1C) in %
Time frame: 3 months
change of fasting blood glucose in mg/dl
Time frame: 3 months
change of fasting blood insulin µU/ml
Time frame: 3 months
change of homeostasis model assessment of insulin resistance (HOMA-IR) (fasting blood glucose and fasting blood insulin will be combined to report HOMA-IR)
Time frame: at baseline
height in cm
West German Center of Diabetes and Health
Other
Düsseldorf Bread Study on Health Effects of Bread.
Acronym: DBS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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