Düsseldorf Bread Study

Not Applicable

Completed

• Conditions: Body Weight
• Interventions: Other: carbohydrate rich bread; Other: carbohydrate reduced bread

• Registration Number: NCT04248673
• Lead Sponsor: West German Center of Diabetes and Health

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-01-22
• Study First Submitted QC: 2020-01-28
• Study First Posted: 2020-01-30
• Study Start: 2020-08-01
• Status Verified: 2021-10
• Primary Completion: 2021-10-21
• Study Completion: 2021-10-21
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
carbohydrate rich bread	carbohydrate rich bread	-
carbohydrate reduced bread	carbohydrate reduced bread	-

Primary Outcome Measures

Name	Time	Method
body weight	3 months	change of body weight in kg

Secondary Outcome Measures

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

Trial Locations

Locations (1)

West German Centre of Diabetes and Health; 🇩🇪 Düsseldorf, Germany