Effect of breakfast cereals compared with corn flakes on blood glucose, gastric emptying and satiety in healthy subjects

ISRCTN	ISRCTN90535566
DOI	https://doi.org/10.1186/ISRCTN90535566
Secondary identifying numbers	NTR971

Submission date: 27/06/2007
Registration date: 27/06/2007
Last edited: 13/11/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Joanna Hlebowicz
Scientific

Malmo University Hospital
Department of Medicine
Ingang 35
Malmo
205 02
Sweden

Phone	+46 (0)40 331 000
Email	Joanna.Hlebowicz@skane.se

Study information

Study design	Randomised, double-blind, crossover trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
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
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Beta-glucan
Primary outcome measure	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 study start date	01/04/2003
Completion date	01/01/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	12
Key inclusion criteria	Healthy subjects without symptoms or a prior history of gastrointestinal disease, abdominal surgery or diabetes mellitus were included in the study.
Key exclusion criteria	1. Diabetes mellitus 2. Prior abdominal surgery 3. Symptoms of gastrointestinal disease 4. Obesity
Date of first enrolment	01/04/2003
Date of final enrolment	01/01/2004

Locations

Countries of recruitment

Netherlands
Sweden

Study participating centre

Malmo University Hospital

Malmo
205 02
Sweden

Sponsor information

Malmö University Hospital (Sweden)
Hospital/treatment centre

Department of Medicine
Ingang 35
Malmö
205 02
Sweden

Website	http://www.hand.mas.lu.se/malmo_unv_hosp.htm
"ROR"	https://ror.org/05wp7an13

Funders

Funder type

Industry

Skånemejerier (Sweden)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan