Postprandial Effects of Functional Bread

• Sponsor: University of Bergen (Other)
• Overall Status: Completed
• CT.gov ID: NCT04289545
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 5
• Actual Duration (Months): 20.2
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postprandial Hyperglycemia	Dietary Supplement: Functional bread	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Primary Purpose: Basic Science
• Official Title: Postprandial Effects of Functional Bread
• Actual Study Start Date: Nov 1, 2019
• Actual Primary Completion Date: Jul 7, 2021
• Actual Study Completion Date: Jul 7, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. area under the curve of postprandial glucose [180 minutes]

Secondary Outcome Measures

1. area under the curve postprandial insulin [180 minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Bergen, Research Unit for Health Surveys	Bergen		Norway	5020

Sponsors and Collaborators

• University of Bergen

Investigators

• Principal Investigator: Jutta Dierkes, PhD, University of Bergen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Bergen
• ClinicalTrials.gov Identifier: NCT04289545
• Other Study ID Numbers: 11367/2019
• First Posted: Feb 28, 2020
• Last Update Posted: Jul 19, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hyperglycemia

Study Results

No Results Posted as of Jul 19, 2021