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Düsseldorf Bread Study (DBS)

W

West German Center of Diabetes and Health

Status

Completed

Conditions

Body Weight

Treatments

Other: carbohydrate reduced bread
Other: carbohydrate rich bread

Study type

Interventional

Funder types

Other

Identifiers

NCT04248673
Bread study

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

18 to 69 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

80 participants in 2 patient groups, including a placebo group

carbohydrate rich bread
Placebo Comparator group
Treatment:
Other: carbohydrate rich bread
carbohydrate reduced bread
Experimental group
Treatment:
Other: carbohydrate reduced bread

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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