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Completed

NCT Number: NCT04248673

Düsseldorf Bread Study

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.

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Key information

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West German Centre of Diabetes and Health

Düsseldorf, 40591, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carbohydrate reduced bread

Other

Consumption of carbohydrate reduced bread for three months.

carbohydrate rich bread

Other

Consumption of carbohydrate rich bread for three months.

Primary outcomes

  1. body weight

    Time frame: 3 months

    change of body weight in kg

Secondary outcomes

  1. body mass index

    Time frame: 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

    Time frame: 3 months

    change of weight circumference in cm

  3. waist-to-height-index

    Time frame: 3 months

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

  4. hip circumference

    Time frame: 3 months

    change of hip circumference in cm

  5. blood pressure

    Time frame: 3 months

    change of blood pressure in mmHg

  6. triglycerides

    Time frame: 3 months

    change of triglycerides in mg/dl

  7. total cholesterol

    Time frame: 3 months

    change of total cholesterol in mg/dl

  8. high-density lipoprotein (HDL) cholesterol

    Time frame: 3 months

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

  9. low-density lipoprotein (HDL) cholesterol

    Time frame: 3 months

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

  10. hemoglobin A1c (HbA1C)

    Time frame: 3 months

    change of hemoglobin A1c (HbA1C) in %

  11. fasting blood glucose

    Time frame: 3 months

    change of fasting blood glucose in mg/dl

  12. fasting blood insulin

    Time frame: 3 months

    change of fasting blood insulin µU/ml

  13. homeostasis model assessment of insulin resistance (HOMA-IR)

    Time frame: 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

    Time frame: at baseline

    height in cm

Sponsors and collaborators

Lead sponsor

West German Center of Diabetes and Health

Other

Collaborators

  • Bakery Hinkel

Registry information

Official study title

Düsseldorf Bread Study on Health Effects of Bread.

Acronym: DBS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 30, 2020
Registry last updated
Oct 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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