| - candidate number | 2579 |
| - NTR Number | NTR971 |
| - ISRCTN | ISRCTN90535566 |
| - Date ISRCTN created | 27-jun-2007 |
| - date ISRCTN requested | 11-jun-2007 |
| - Date Registered NTR | 15-mei-2007 |
| - Secondary IDs | |
| - Public Title | Effect of breakfast cereals compared with corn flakes on blood glucose, gastric emptying and satiety in healthy subjects. |
| - Scientific Title | Effect of ß-glucan breakfast cereals compared with corn flakes on postprandial blood glucose, gastric emptying and satiety in healthy subjects: a randomized crossover blinded trial. |
| - ACRONYM | N/A |
| - hypothesis | The aim of this study was to evaluate the effect of ß-glucan on the rate of gastric emptying, postprandial glucose response and satiety in healthy subjects. |
| - Healt Condition(s) or Problem(s) studied | Beta-glucan, Gastric emptying, Postprandial blood glucose, Healthy subjects |
| - Inclusion criteria | Helthy subjects without symptoms or a prior history of gastrointestinal disease, abdominal surgery or diabetes mellitus were included in the study. |
| - Exclusion criteria | 1. Diabetes mellitus; 2. prior abdominal surgery; 3. symtoms of gastrointestinal disease; 4. Obesity. |
| - mec approval received | no |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Not applicable |
| - group | Crossover |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-apr-2003 |
| - planned closingdate | 1-jan-2004 |
| - Target number of participants | 12 |
| - Interventions | Twelve healthy subjects were assessed using a randomized crossover blinded trial. The subjects were examined after an 8 hours 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. |
| - Primary outcome | The ß-glucan effect on the rate of gastric emptying was statistically not significant compared with cornflakes. Consumption of ß-glucan lowered the postprandial glucose response significant (p<0.05). |
| - Secondary outcome | The effect of ß-glucan on satiety was not statistically significant. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | stopped: trial finished |
| - CONTACT FOR PUBLIC QUERIES | MD. Joanna Hlebowicz |
| - CONTACT for SCIENTIFIC QUERIES | MD. Joanna Hlebowicz |
| - Sponsor/Initiator | Malmö University Hospital |
| - Funding (Source(s) of Monetary or Material Support) | Skånemejerier, Malmö, Sweden |
| - Publications | Nutr J. 2007 Sep 17;6:22. |
| - Brief summary | World wide the incidence of type 2 diabetes mellitus is increasing rapidly. To prevent development of diabetes mellitus it is recommended by the American Diabetes Association to consume dietary fiber food. Products enriched with â-glucan have been shown to reduce postprandial glucose and insulinemic responses in healthy subjects and in type 2 diabetes patients. Gastric emptying, among other factors, regulates the postprandial blood glucose response, and a delay in gastric emptying rate leads to a lower postprandial blood glucose response. Delayed gastric emptying occurs in 30-50 % of diabetes patients. This is an important issue that should be evaluated because of the nutrition recommendations with an increased intake of fiber and a high prevalence of delayed gastric emptying among diabetes patients. Patients with diabetes are recommended to consume commercial products with fibre to control the blood glucose levels. However, commercial products have not been properly evaluated regarding postprandial blood-glucose levels and gastric emptying. The result of this randomized crossover blinded study demonstrates that intake of commercial breakfast cereals with fiber affects gastric emptying without reducing the postprandial blood glucose in the same extent and can therefore not bee recommended to be consumed to control the blood glucose levels. |
| - Main changes (audit trail) | |
| - RECORD | 15-mei-2007 - 7-aug-2008 |
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