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
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