Postprandial Effects of Functional Bread

NCT ID: NCT04289545

Last Updated: 2021-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2021-07-07

Brief Summary

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

Detailed Description

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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.

Conditions

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Postprandial Hyperglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control Bread

no added guar gum

Group Type PLACEBO_COMPARATOR

Functional bread

Intervention Type DIETARY_SUPPLEMENT

Postprandial effects of bread containing galactomannan

Functional Bread 1

10% guar gum, low molecular weight

Group Type ACTIVE_COMPARATOR

Functional bread

Intervention Type DIETARY_SUPPLEMENT

Postprandial effects of bread containing galactomannan

functional Bread 2

10% guar gum, high molecular weight

Group Type ACTIVE_COMPARATOR

Functional bread

Intervention Type DIETARY_SUPPLEMENT

Postprandial effects of bread containing galactomannan

Functional Bread 3

15% guar gum, low molecular weight

Group Type ACTIVE_COMPARATOR

Functional bread

Intervention Type DIETARY_SUPPLEMENT

Postprandial effects of bread containing galactomannan

Functional Bread 4

15% guar gum, high molecular weight

Group Type ACTIVE_COMPARATOR

Functional bread

Intervention Type DIETARY_SUPPLEMENT

Postprandial effects of bread containing galactomannan

Interventions

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Functional bread

Postprandial effects of bread containing galactomannan

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bergen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jutta Dierkes, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bergen

Locations

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University of Bergen, Research Unit for Health Surveys

Bergen, , Norway

Site Status

Countries

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Norway

Other Identifiers

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11367/2019

Identifier Type: -

Identifier Source: org_study_id

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