Düsseldorf Bread Study | NCT04248673

Studies
Düsseldorf Bread Study

NCT04248673

Sponsor

West German Center of Diabetes and Health

Status

Completed

Last Update Posted

Oct 28, 2021Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Body Weight

Interventions

carbohydrate reduced bread
carbohydrate rich bread

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2020Actual

Primary Completion Date

Oct 21, 2021Actual

Completion Date

Oct 21, 2021Actual

First Submitted Date

Jan 22, 2020

First Submission Date that Met QC Criteria

Jan 28, 2020

First Posted Date

Jan 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 27, 2021

Last Update Posted Date

Oct 28, 2021Actual

Name	Class
Bakery Hinkel	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
carbohydrate rich bread	Placebo Comparator		Other: carbohydrate rich bread
carbohydrate reduced bread	Experimental		Other: carbohydrate reduced bread

Interventions

Name	Type	Description	Arm Group Labels	Other Names
carbohydrate reduced bread	Other	Consumption of carbohydrate reduced bread for three months.	carbohydrate reduced bread

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
body weight	change of body weight in kg	3 months

Secondary Outcomes

Measure	Description	Time Frame
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
waist circumference	change of weight circumference in cm

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
West German Centre of Diabetes and Health		Düsseldorf		40591	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001835	Body Weight

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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