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Postprandial Effects of Functional Bread

U

University of Bergen

Status

Completed

Conditions

Postprandial Hyperglycemia

Treatments

Dietary Supplement: Functional bread

Study type

Interventional

Funder types

Other

Identifiers

NCT04289545
11367/2019

Details and patient eligibility

About

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

Full 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.

Enrollment

12 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

12 participants in 5 patient groups, including a placebo group

Control Bread
Placebo Comparator group
Description:
no added guar gum
Treatment:
Dietary Supplement: Functional bread
Functional Bread 1
Active Comparator group
Description:
10% guar gum, low molecular weight
Treatment:
Dietary Supplement: Functional bread
functional Bread 2
Active Comparator group
Description:
10% guar gum, high molecular weight
Treatment:
Dietary Supplement: Functional bread
Functional Bread 3
Active Comparator group
Description:
15% guar gum, low molecular weight
Treatment:
Dietary Supplement: Functional bread
Functional Bread 4
Active Comparator group
Description:
15% guar gum, high molecular weight
Treatment:
Dietary Supplement: Functional bread

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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