Back to resultsPostprandial Effects of Functional Bread
Primary Purpose
Postprandial Hyperglycemia
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Functional bread
Sponsored by
About this trial
This is an interventional basic science trial for Postprandial Hyperglycemia
Eligibility Criteria
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
Sites / Locations
- University of Bergen, Research Unit for Health Surveys
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Control Bread
Functional Bread 1
functional Bread 2
Functional Bread 3
Functional Bread 4
Arm Description
no added guar gum
10% guar gum, low molecular weight
10% guar gum, high molecular weight
15% guar gum, low molecular weight
15% guar gum, high molecular weight
Outcomes
Primary Outcome Measures
area under the curve of postprandial glucose
Secondary Outcome Measures
area under the curve postprandial insulin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04289545
Brief Title
Postprandial Effects of Functional Bread
Official Title
Postprandial Effects of Functional Bread
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
July 7, 2021 (Actual)
Study Completion Date
July 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bergen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study investigates whether bread with added galactomannan, a soluble fiber, can reduce the postprandial glucose response in healthy overweight adults.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprandial Hyperglycemia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Bread
Arm Type
Placebo Comparator
Arm Description
no added guar gum
Arm Title
Functional Bread 1
Arm Type
Active Comparator
Arm Description
10% guar gum, low molecular weight
Arm Title
functional Bread 2
Arm Type
Active Comparator
Arm Description
10% guar gum, high molecular weight
Arm Title
Functional Bread 3
Arm Type
Active Comparator
Arm Description
15% guar gum, low molecular weight
Arm Title
Functional Bread 4
Arm Type
Active Comparator
Arm Description
15% guar gum, high molecular weight
Intervention Type
Dietary Supplement
Intervention Name(s)
Functional bread
Intervention Description
Postprandial effects of bread containing galactomannan
Primary Outcome Measure Information:
Title
area under the curve of postprandial glucose
Time Frame
180 minutes
Secondary Outcome Measure Information:
Title
area under the curve postprandial insulin
Time Frame
180 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jutta Dierkes, PhD
Organizational Affiliation
University of Bergen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Bergen, Research Unit for Health Surveys
City
Bergen
ZIP/Postal Code
5020
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
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Postprandial Effects of Functional Bread
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