Effects of Added D-fagomine on Glycaemic Responses to Sucrose
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|ClinicalTrials.gov Identifier: NCT01811303|
Recruitment Status : Completed
First Posted : March 14, 2013
Results First Posted : July 2, 2013
Last Update Posted : July 2, 2013
|Condition or disease||Intervention/treatment||Phase|
|Reduction of Post-prandial Glycaemic Response||Other: D-fagomine||Not Applicable|
This is a two treatment randomized double-blind crossover study, with each test product replicated twice.
Randomization: Subjects will be randomized to a Williams Latin square design balanced for treatment order.
Washout: 2 days or more (may return on day 3)
Run-in: High carbohydrate diet guidance (>150 g/d) 1 day before treatment, recommend same sized dinner the previous night (no food record collection required)
Drop-outs: Subjects who have dropped out before visit 2 will be replaced by another subject randomized in their place (the new subject will complete all treatments)
Subjects will report after an overnight (12 hour) fast for baseline sample collection, and will consume the test product in a fasted state.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Effects of Added D-fagomine on Glycaemic Responses to Sucrose|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
Measure the changes produced on the postprandial Glycaemic response to 50 g of sucrose containing 40 mg D-fagomine, in 200 ml water
Measure the changes produced on the postprandial Glycaemic response to 50 g of sucrose in 200 ml water if added 40 mg D-fagomine
Placebo Comparator: Control
Sucrose 50 g without d-fagomine, in 200 ml water
- Postprandial Glycaemic Response Index [ Time Frame: 120 minutes ]On each intervention, the volunteer measured a baseline fasting blood sugar measurement for that day and repeated this approximately 5 minutes later so that two fasting measurements were obtained under the supervision of staff. All of the subsequent measurements were assessed against the average of the two baseline readings. Each subject was then presented with a test product and they were instructed to consume the whole amount within a fifteen-minute period. Each volunteer then took a blood sugar readings at 15, 30, 45, 60, 90 and 120 minutes following the initiation of consumption of the test product. Measurements were taken using the Ascensia Contour, Blood Glucose Monitoring Systems (Bayer), which analysed the blood sample and provided a blood glucose reading in mmol/l. The AUC is calculated using the trapezoid rule and the final outcome is the incremental area under the curve for the arm expressed as a percent of the average response for the control by the same subject.
- Maximum Blood Glucose Concentration (C Max) Over the Baseline [ Time Frame: Usually in the range of 30-45 minutes ]
Determine the glucose C max of Sucrose with D-fagomine over the baseline.
The blood glucose maximum concentration (C-Max) expressed in mmol/L of the average response for a 50g sucrose, over the baseline.
Calculation of the outcome is= (Measure glucose C-Max - Measure glucose baseline)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811303
|Reading Scientific Services Ltd.|
|Reading, United Kingdom, RG6 6LA|
|Principal Investigator:||Rungano Munyuki||Reading Scientific Services Ltd.|