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 |
| Protocol serial number | NTR971 |
| Sponsor | Malmö University Hospital (Sweden) |
| Funder | Skånemejerier (Sweden) |
- 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
Scientific
Malmo University Hospital
Department of Medicine
Ingang 35
Malmo
205 02
Sweden
| Phone | +46 (0)40 331 000 |
|---|---|
| Joanna.Hlebowicz@skane.se |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double-blind, crossover trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Beta-glucan |
| Primary outcome measure(s) |
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). |
| Key secondary outcome measure(s) |
The effect of beta-glucan on satiety was not statistically significant. |
| Completion date | 01/01/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
205 02
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
