Düsseldorf Bread Study

Body Weight Clinical Trial

— DBS  

Official title:

Düsseldorf Bread Study on Health Effects of Bread.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04248673
• Other study ID #: Bread study
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: October 21, 2021

Study information

• Verified date: October 2021
• Source: West German Center of Diabetes and Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 21, 2021
• Est. primary completion date: October 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight

Intervention

Other:
• carbohydrate reduced bread
Consumption of carbohydrate reduced bread for three months.
• carbohydrate rich bread
Consumption of carbohydrate rich bread for three months.

Locations

Country	Name	City	State
Germany	West German Centre of Diabetes and Health	Düsseldorf

Sponsors (2)

Lead Sponsor	Collaborator
West German Center of Diabetes and Health	Bakery Hinkel

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body weight	change of body weight in kg	3 months
Secondary	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
Secondary	waist circumference	change of weight circumference in cm	3 months
Secondary	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
Secondary	hip circumference	change of hip circumference in cm	3 months
Secondary	blood pressure	change of blood pressure in mmHg	3 months
Secondary	triglycerides	change of triglycerides in mg/dl	3 months
Secondary	total cholesterol	change of total cholesterol in mg/dl	3 months
Secondary	high-density lipoprotein (HDL) cholesterol	change of high-density lipoprotein (HDL) cholesterol in mg/dl	3 months
Secondary	low-density lipoprotein (HDL) cholesterol	change of low-density lipoprotein (HDL) cholesterol in mg/dl	3 months
Secondary	hemoglobin A1c (HbA1C)	change of hemoglobin A1c (HbA1C) in %	3 months
Secondary	fasting blood glucose	change of fasting blood glucose in mg/dl	3 months
Secondary	fasting blood insulin	change of fasting blood insulin µU/ml	3 months
Secondary	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
Secondary	height	height in cm	at baseline