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Completed

NCT Number: NCT04289545

Postprandial Effects of Functional Bread

This study investigates whether bread with added galactomannan, a soluble fiber, can reduce the postprandial glucose response in healthy overweight adults.

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Key information

Conditions

Postprandial Hyperglycemia Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bergen, Research Unit for Health Surveys

Bergen, 5020, Norway

About this study

This single-blind crossover-designed study wants to investigate the postprandial effect of functional bread in healthy overweight adults. Therefore, four types of bread, consumed by the participants, have added galactomannan in different amounts and viscosities, and one bread is the control bread.

The participants arrive after an overnight fast and before the consumption of bread, a fasting blood sample is taken.

After the ingestion, blood samples are taken at specific times. The area under the curve of the postprandial glucose is expected to differ between the functional breads.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy, overweight adults (BMI between 25 and 30 kg/m2)

Exclusion criteria

  • Known diagnosis of diabetes mellitus type 2
  • HbA1c at screening ≥ 48 mmol/mol
  • Other chronic diseases (heart disease, cancer) within the last 3 years
  • Pregnancy and lactation
  • Known drug or alcohol abuse
  • Unwilling to follow the study requirements

Treatment and study plan

Functional bread

Dietary Supplement

Postprandial effects of bread containing galactomannan

Primary outcomes

  1. area under the curve of postprandial glucose

    Time frame: 180 minutes

Secondary outcomes

  1. area under the curve postprandial insulin

    Time frame: 180 minutes

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 28, 2020
Registry last updated
Jul 19, 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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