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NCT04289545 Clinical Trial

Postprandial Effects of Functional Bread

Postprandial Hyperglycemia Clinical Trial

Official title:
Postprandial Effects of Functional Bread

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04289545
Other study ID # 11367/2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2019
Est. completion date July 7, 2021

Study information
Verified date July 2021
Source University of Bergen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date July 7, 2021
Est. primary completion date July 7, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Functional bread
Postprandial effects of bread containing galactomannan

Locations
Country Name City State
Norway University of Bergen, Research Unit for Health Surveys Bergen

Sponsors (1)
Lead Sponsor Collaborator
University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary area under the curve of postprandial glucose 180 minutes
Secondary area under the curve postprandial insulin 180 minutes
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