Düsseldorf Bread Study

West German Center of Diabetes and Health80 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Body Weight

Interventions

carbohydrate reduced breadOTHER

Consumption of carbohydrate reduced bread for three months.

carbohydrate rich breadOTHER

Consumption of carbohydrate rich bread for three months.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

West German Centre of Diabetes and Health

Düsseldorf, Germany

Outcomes

Primary Outcomes

body weight

change of body weight in kg

Time frame: 3 months

Secondary Outcomes

body mass index

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

waist circumference

change of weight circumference in cm

Time frame: 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)

Time frame: 3 months

hip circumference

change of hip circumference in cm

Time frame: 3 months

blood pressure

change of blood pressure in mmHg

Time frame: 3 months

triglycerides

change of triglycerides in mg/dl

Time frame: 3 months

total cholesterol

change of total cholesterol in mg/dl

Time frame: 3 months

high-density lipoprotein (HDL) cholesterol

change of high-density lipoprotein (HDL) cholesterol in mg/dl

Time frame: 3 months

Data from ClinicalTrials.gov

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