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Düsseldorf Bread Study

NCT ID: NCT04248673

Last Updated: 2021-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-10-21

Brief Summary

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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

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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.

Conditions

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Body Weight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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carbohydrate rich bread

Group Type PLACEBO_COMPARATOR

carbohydrate rich bread

Intervention Type OTHER

Consumption of carbohydrate rich bread for three months.

carbohydrate reduced bread

Group Type EXPERIMENTAL

carbohydrate reduced bread

Intervention Type OTHER

Consumption of carbohydrate reduced bread for three months.

Interventions

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carbohydrate reduced bread

Consumption of carbohydrate reduced bread for three months.

Intervention Type OTHER

carbohydrate rich bread

Consumption of carbohydrate rich bread for three months.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bakery Hinkel

UNKNOWN

Sponsor Role collaborator

West German Center of Diabetes and Health

OTHER

Sponsor Role lead

Responsible Party

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Stephan Martin

director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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West German Centre of Diabetes and Health

Düsseldorf, , Germany

Site Status

Countries

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Germany

Other Identifiers

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Bread study

Identifier Type: -

Identifier Source: org_study_id