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Clinical Trials/NCT04289545
NCT04289545CompletedNot Applicable

Postprandial Effects of Functional Bread

University of Bergen1 site in 1 country12 target enrollmentStarted: November 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
12
Locations
1
Primary Endpoint
area under the curve of postprandial glucose

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
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

Arms & Interventions

Control Bread

Placebo Comparator

no added guar gum

Intervention: Functional bread (Dietary Supplement)

Functional Bread 1

Active Comparator

10% guar gum, low molecular weight

Intervention: Functional bread (Dietary Supplement)

functional Bread 2

Active Comparator

10% guar gum, high molecular weight

Intervention: Functional bread (Dietary Supplement)

Functional Bread 3

Active Comparator

15% guar gum, low molecular weight

Intervention: Functional bread (Dietary Supplement)

Functional Bread 4

Active Comparator

15% guar gum, high molecular weight

Intervention: Functional bread (Dietary Supplement)

Outcomes

Primary Outcomes

area under the curve of postprandial glucose

Time Frame: 180 minutes

Secondary Outcomes

  • area under the curve postprandial insulin(180 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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