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.

Study Overview

• Status: Completed
• Conditions: Postprandial Hyperglycemia
• Intervention / Treatment: Dietary supplement: Functional bread

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 5020
    • University of Bergen, Research Unit for Health Surveys

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Control Bread; no added guar gum	Dietary supplement: Functional bread; Postprandial effects of bread containing galactomannan
ACTIVE_COMPARATOR: Functional Bread 1; 10% guar gum, low molecular weight	Dietary supplement: Functional bread; Postprandial effects of bread containing galactomannan
ACTIVE_COMPARATOR: functional Bread 2; 10% guar gum, high molecular weight	Dietary supplement: Functional bread; Postprandial effects of bread containing galactomannan
ACTIVE_COMPARATOR: Functional Bread 3; 15% guar gum, low molecular weight	Dietary supplement: Functional bread; Postprandial effects of bread containing galactomannan
ACTIVE_COMPARATOR: Functional Bread 4; 15% guar gum, high molecular weight	Dietary supplement: Functional bread; Postprandial effects of bread containing galactomannan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
area under the curve of postprandial glucose	180 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
area under the curve postprandial insulin	180 minutes

Collaborators and Investigators

• Sponsor: University of Bergen

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2019
• Primary Completion (ACTUAL): July 7, 2021
• Study Completion (ACTUAL): July 7, 2021

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: February 26, 2020
• First Posted (ACTUAL): February 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2021
• Last Update Submitted That Met QC Criteria: July 16, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia
• Other Study ID Numbers: 11367/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No