Clinical trial NCT04248673: Düsseldorf Bread Study
Official title: Düsseldorf Bread Study on Health Effects of Bread.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight
Lead sponsor: West German Center of Diabetes and Health
Sponsor class: OTHER
Collaborators: name: Bakery Hinkel
First posted: 2020-01-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: body weight
timeFrame: 3 months
Secondary outcomes:
measure: body mass index
timeFrame: 3 months
measure: waist circumference
timeFrame: 3 months
measure: waist-to-height-index
timeFrame: 3 months
measure: hip circumference
timeFrame: 3 months
measure: blood pressure
timeFrame: 3 months
measure: triglycerides
timeFrame: 3 months
measure: total cholesterol
timeFrame: 3 months
measure: high-density lipoprotein (HDL) cholesterol
timeFrame: 3 months
measure: low-density lipoprotein (HDL) cholesterol
timeFrame: 3 months
measure: hemoglobin A1c (HbA1C)
timeFrame: 3 months
measure: fasting blood glucose
timeFrame: 3 months
measure: fasting blood insulin
timeFrame: 3 months
measure: homeostasis model assessment of insulin resistance (HOMA-IR)
timeFrame: 3 months
measure: height
timeFrame: at baseline
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: West German Centre of Diabetes and Health
Study officials:
References: