NCT04289545

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2021

Completed
Last Updated

July 19, 2021

Status Verified

July 1, 2021

Enrollment Period

1.7 years

First QC Date

February 26, 2020

Last Update Submit

July 16, 2021

Conditions

Postprandial Hyperglycemia

Outcome Measures

Primary Outcomes (1)

  • area under the curve of postprandial glucose

    180 minutes

Secondary Outcomes (1)

  • area under the curve postprandial insulin

    180 minutes

Study Arms (5)

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

Functional breadDIETARY_SUPPLEMENT

Postprandial effects of bread containing galactomannan

Control BreadFunctional Bread 1Functional Bread 3Functional Bread 4functional Bread 2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy, overweight adults (BMI between 25 and 30 kg/m2)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bergen, Research Unit for Health Surveys

Bergen, 5020, Norway

Location

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jutta Dierkes, PhD

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2020

First Posted

February 28, 2020

Study Start

November 1, 2019

Primary Completion

July 7, 2021

Study Completion

July 7, 2021

Last Updated

July 19, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)