Düsseldorf Bread Study (DBS)

Düsseldorf Bread Study on Health Effects of Bread.

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.

Study Overview

• Status: Completed
• Conditions: Body Weight
• Intervention / Treatment: Other: carbohydrate rich bread; Other: carbohydrate reduced 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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Düsseldorf, Germany, 40591
    • West German Centre of Diabetes and Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: carbohydrate rich bread	Other: carbohydrate rich bread; Consumption of carbohydrate rich bread for three months.
Experimental: carbohydrate reduced bread	Other: carbohydrate reduced bread; Consumption of carbohydrate reduced bread for three months.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: West German Center of Diabetes and Health
• Collaborators: Bakery Hinkel

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): October 21, 2021
• Study Completion (Actual): October 21, 2021

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: January 28, 2020
• First Posted (Actual): January 30, 2020

Study Record Updates

• Last Update Posted (Actual): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight
• Other Study ID Numbers: Bread study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No