DBS: Düsseldorf Bread Study

• Sponsor: West German Center of Diabetes and Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT04248673
• Collaborator: Bakery Hinkel (Other)
• Enrollment: 80
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.7
• Patients Per Site Per Month: 5.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Body Weight	Other: carbohydrate reduced bread; Other: carbohydrate rich bread	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Düsseldorf Bread Study on Health Effects of Bread.
• Actual Study Start Date: Aug 1, 2020
• Actual Primary Completion Date: Oct 21, 2021
• Actual Study Completion Date: Oct 21, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. body weight [3 months]

   change of body weight in kg

Secondary Outcome Measures

1. body mass index [3 months]

   change of body mass index in kg/m*m (body weight and height will be combined to report body mass index)

2. waist circumference [3 months]

   change of weight circumference in cm

3. waist-to-height-index [3 months]

   change of waist-to-height-index (waist circumference and height will be combined to report waist-to-height-index)

4. hip circumference [3 months]

   change of hip circumference in cm

5. blood pressure [3 months]

   change of blood pressure in mmHg

6. triglycerides [3 months]

   change of triglycerides in mg/dl

7. total cholesterol [3 months]

   change of total cholesterol in mg/dl

8. high-density lipoprotein (HDL) cholesterol [3 months]

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

9. low-density lipoprotein (HDL) cholesterol [3 months]

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

10. hemoglobin A1c (HbA1C) [3 months]

    change of hemoglobin A1c (HbA1C) in %

11. fasting blood glucose [3 months]

    change of fasting blood glucose in mg/dl

12. fasting blood insulin [3 months]

    change of fasting blood insulin µU/ml

13. homeostasis model assessment of insulin resistance (HOMA-IR) [3 months]

    change of homeostasis model assessment of insulin resistance (HOMA-IR) (fasting blood glucose and fasting blood insulin will be combined to report HOMA-IR)

14. height [at baseline]

    height in cm

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 69 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West German Centre of Diabetes and Health	Düsseldorf		Germany	40591

Sponsors and Collaborators

• West German Center of Diabetes and Health
• Bakery Hinkel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stephan Martin, director, West German Center of Diabetes and Health
• ClinicalTrials.gov Identifier: NCT04248673
• Other Study ID Numbers: Bread study
• First Posted: Jan 30, 2020
• Last Update Posted: Oct 28, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Body Weight

Study Results

No Results Posted as of Oct 28, 2021