Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/06/2007
Date assigned
27/06/2007
Last edited
13/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Joanna Hlebowicz

ORCID ID

Contact details

Malmo University Hospital
Department of Medicine
Ingang 35
Malmo
205 02
Sweden
+46 (0)40 331 000
Joanna.Hlebowicz@skane.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR971

Study information

Scientific title

Effect of beta-glucan breakfast cereals compared with corn flakes on post-prandial blood glucose, gastric emptying and satiety in healthy subjects: a randomised crossover blinded trial

Acronym

Study hypothesis

The aim of this study was to evaluate the effect of beta-glucan on the rate of gastric emptying, post-prandial glucose response and satiety in healthy subjects.

Ethics approval

Not provided at time of registration

Study design

Randomised, double-blind, crossover trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

Gastric emptying, post-prandial blood glucose

Intervention

Twelve healthy subjects were assessed using a randomised crossover blinded trial. The subjects were examined after an eight-hour fast and assessment of normal fasting blood glucose level. Gastric emptying rate was calculated as the percentage change in the antral cross-sectional area 15 and 90 minutes after ingestion of vanilla yoghurt with flakes containing 4 g beta-glucan (GER1) or vanilla yoghurt with Kellogg's cornflakes (GER2). Significant differences were evaluated with Wilcoxon t-test.

Intervention type

Drug

Phase

Not Specified

Drug names

Beta-glucan

Primary outcome measures

The beta-glucan effect on the rate of gastric emptying was statistically not significant compared with cornflakes. Consumption of beta-glucan lowered the post-prandial glucose response significant (p < 0.05).

Secondary outcome measures

The effect of beta-glucan on satiety was not statistically significant.

Overall trial start date

01/04/2003

Overall trial end date

01/01/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy subjects without symptoms or a prior history of gastrointestinal disease, abdominal surgery or diabetes mellitus were included in the study.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

12

Participant exclusion criteria

1. Diabetes mellitus
2. Prior abdominal surgery
3. Symptoms of gastrointestinal disease
4. Obesity

Recruitment start date

01/04/2003

Recruitment end date

01/01/2004

Locations

Countries of recruitment

Netherlands

Trial participating centre

Malmo University Hospital
Malmo
205 02
Sweden

Sponsor information

Organisation

Malmö University Hospital (Sweden)

Sponsor details

Department of Medicine
Ingang 35
Malmö
205 02
Sweden

Sponsor type

Hospital/treatment centre

Website

http://www.hand.mas.lu.se/malmo_unv_hosp.htm

Funders

Funder type

Industry

Funder name

Skånemejerier (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes