NCT04571866

Brief Summary

The rate of gastric emptying is proposed to be one of the major determinants of postprandial glycemia. A slower gastric emptying will thus result in a less pronounced rise in blood glucose, which is especially desirable in diabetes care as it will highly influence the overall glycemic control. The present study aims to investigate the rate of gastric emptying and postprandial blood glucose levels in response to the intake of bread with different dietary fiber-content. Though bread is one of the major sources of dietary carbohydrates in Central- and Northern Europe, the mechanism and the metabolic effects of bread consumption, however, is investigated in a limited number of studies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

September 21, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 1, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

October 20, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
Last Updated

July 13, 2021

Status Verified

July 1, 2021

Enrollment Period

3 months

First QC Date

September 21, 2020

Last Update Submit

July 7, 2021

Conditions

Gastric Emptying

Keywords

Gastric emptyingCarbohydrateBread consumptionBeta-glucanMetabolic response

Outcome Measures

Primary Outcomes (1)

  • Difference in gastric emptying (antral area, cm2) )

    Differences in antral area (cm2) at different time points after ingestion of standardised meals. The antral area is measured by real-time ultrasonography.

    2 hours

Secondary Outcomes (4)

  • Satiety hormones

    2 hours

  • Subjective satiety

    2 hours

  • Postprandial blood glucose

    2 hours

  • Insulin

    2 hours

Study Arms (2)

Beta-glucan bread

EXPERIMENTAL

Participants will receive a standardised meal consisting of beta-glucan-enriched bread (in an amount corresponding to 25 g of available dietary carbohydrates) and water (250 ml). The bread is produced by NOFIMA AS, one of the collaborating parties. The participants will be asked to spend approximately 10 minutes consuming the standardised meal.

Other: Beta-glucan bread

Control bread

SHAM COMPARATOR

Participants will receive a standardised meal consisting of a wheat bread with no additives (in an amount corresponding to 25 g of available dietary carbohydrates) and water (250 ml). The bread is produced by NOFIMA AS, one of the collaborating parties. The participant will be asked to spend approximately 10 minutes consuming the standardised meal.

Other: Beta-glucan bread

Interventions

Beta-glucan breadOTHER

Beta-glucan is a dietary fiber with beneficial health effects, both on cholesterol levels and potentially blood glucose levels.

Beta-glucan breadControl bread

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults 18-40 years
  • BMI: 18.5-30 kg/m2
  • Healthy

You may not qualify if:

  • Celiac disease, non-celiac gluten sensitivity or wheat allergy and intolerance
  • Use of medication that can affect gastric emptying
  • Gastroparesis
  • Gastrointestinal diseases
  • Gastrointestinal surgery including bariatric surgery
  • Chronic alcohol abuse
  • Current smoker
  • Pregnant or lactating women
  • Diabetes mellitus type 1 and 2
  • Anorexia nervosa or bulimia nervosa

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bergen

Bergen, 5021, Norway

Location

Related Publications (1)

  • Revheim I, Ballance S, Standal AF, Rieder A, Dierkes J, Buyken AE, Gilja OH, Hausken T, Rosendahl-Riise H. The acute effect of a beta-glucan-enriched oat bread on gastric emptying, GLP-1 response, and postprandial glycaemia and insulinemia: a randomised crossover trial in healthy adults. Nutr Metab (Lond). 2024 Mar 18;21(1):13. doi: 10.1186/s12986-024-00789-w.

    PMID: 38500209DERIVED

Study Officials

  • Jutta Dierkes, PhD

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 21, 2020

First Posted

October 1, 2020

Study Start

October 20, 2020

Primary Completion

January 15, 2021

Study Completion

February 15, 2021

Last Updated

July 13, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available

Locations

NO(1)