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Düsseldorf Bread Study (DBS)

Primary Purpose

Body Weight

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
carbohydrate reduced bread
carbohydrate rich bread
Sponsored by
West German Center of Diabetes and Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Body Weight

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • West German Centre of Diabetes and Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

carbohydrate rich bread

carbohydrate reduced bread

Arm Description

Outcomes

Primary Outcome Measures

body weight
change of body weight in kg

Secondary Outcome Measures

body mass index
change of body mass index in kg/m*m (body weight and height will be combined to report body mass index)
waist circumference
change of weight circumference in cm
waist-to-height-index
change of waist-to-height-index (waist circumference and height will be combined to report waist-to-height-index)
hip circumference
change of hip circumference in cm
blood pressure
change of blood pressure in mmHg
triglycerides
change of triglycerides in mg/dl
total cholesterol
change of total cholesterol in mg/dl
high-density lipoprotein (HDL) cholesterol
change of high-density lipoprotein (HDL) cholesterol in mg/dl
low-density lipoprotein (HDL) cholesterol
change of low-density lipoprotein (HDL) cholesterol in mg/dl
hemoglobin A1c (HbA1C)
change of hemoglobin A1c (HbA1C) in %
fasting blood glucose
change of fasting blood glucose in mg/dl
fasting blood insulin
change of fasting blood insulin µU/ml
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)
height
height in cm

Full Information

First Posted
January 22, 2020
Last Updated
October 27, 2021
Sponsor
West German Center of Diabetes and Health
Collaborators
Bakery Hinkel
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1. Study Identification

Unique Protocol Identification Number
NCT04248673
Brief Title
Düsseldorf Bread Study
Acronym
DBS
Official Title
Düsseldorf Bread Study on Health Effects of Bread.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
October 21, 2021 (Actual)
Study Completion Date
October 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West German Center of Diabetes and Health
Collaborators
Bakery Hinkel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
carbohydrate rich bread
Arm Type
Placebo Comparator
Arm Title
carbohydrate reduced bread
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
carbohydrate reduced bread
Intervention Description
Consumption of carbohydrate reduced bread for three months.
Intervention Type
Other
Intervention Name(s)
carbohydrate rich bread
Intervention Description
Consumption of carbohydrate rich bread for three months.
Primary Outcome Measure Information:
Title
body weight
Description
change of body weight in kg
Time Frame
3 months
Secondary Outcome Measure Information:
Title
body mass index
Description
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
Title
waist circumference
Description
change of weight circumference in cm
Time Frame
3 months
Title
waist-to-height-index
Description
change of waist-to-height-index (waist circumference and height will be combined to report waist-to-height-index)
Time Frame
3 months
Title
hip circumference
Description
change of hip circumference in cm
Time Frame
3 months
Title
blood pressure
Description
change of blood pressure in mmHg
Time Frame
3 months
Title
triglycerides
Description
change of triglycerides in mg/dl
Time Frame
3 months
Title
total cholesterol
Description
change of total cholesterol in mg/dl
Time Frame
3 months
Title
high-density lipoprotein (HDL) cholesterol
Description
change of high-density lipoprotein (HDL) cholesterol in mg/dl
Time Frame
3 months
Title
low-density lipoprotein (HDL) cholesterol
Description
change of low-density lipoprotein (HDL) cholesterol in mg/dl
Time Frame
3 months
Title
hemoglobin A1c (HbA1C)
Description
change of hemoglobin A1c (HbA1C) in %
Time Frame
3 months
Title
fasting blood glucose
Description
change of fasting blood glucose in mg/dl
Time Frame
3 months
Title
fasting blood insulin
Description
change of fasting blood insulin µU/ml
Time Frame
3 months
Title
homeostasis model assessment of insulin resistance (HOMA-IR)
Description
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
3 months
Title
height
Description
height in cm
Time Frame
at baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
West German Centre of Diabetes and Health
City
Düsseldorf
ZIP/Postal Code
40591
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Düsseldorf Bread Study

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