Postprandial Effects of Functional Bread | NCT04289545

Studies
Postprandial Effects of Functional Bread

NCT04289545

Sponsor

University of Bergen

Status

Completed

Last Update Posted

Jul 19, 2021Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Postprandial Hyperglycemia

Interventions

Functional bread

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2019Actual

Primary Completion Date

Jul 7, 2021Actual

Completion Date

Jul 7, 2021Actual

First Submitted Date

Feb 26, 2020

First Submission Date that Met QC Criteria

Feb 26, 2020

First Posted Date

Feb 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2021

Last Update Posted Date

Jul 19, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Functional bread	Dietary Supplement	Postprandial effects of bread containing galactomannan	Control Bread Functional Bread 1 Functional Bread 3

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jutta Dierkes, PhD	University of Bergen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Bergen, Research Unit for Health Surveys		Bergen		5020	Norway

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006943	Hyperglycemia

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided