Reduction of Post-prandial Glycaemic Response Clinical Trial
Official title:
Effects of Added D-fagomine on Glycaemic Responses to Sucrose
| Verified date | August 2023 |
| Source | Bioglane |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to determine whether D-fagomine affects glycaemic responses to sucrose (commercial white sugar)and quantify the response
| Status | Completed |
| Enrollment | 14 |
| Est. completion date | March 2013 |
| Est. primary completion date | March 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility | Inclusion Criteria: - Male or female (not less than 40% Male) - Aged 18 - 55 years - Have a body mass index between 18.5 to 29.99 kg/m2 - Healthy, non-diabetic, no gastric bypass surgery - Have a fasting plasma glucose (finger-stick) <100 mg/dl (<5.5 mmol/L) - Willing and able to provide written informed consent Exclusion Criteria: - Smokers - Allergic to dairy or soy |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Reading Scientific Services Ltd. | Reading |
| Lead Sponsor | Collaborator |
|---|---|
| Bioglane |
United Kingdom,
Amezqueta S, Galan E, Vila-Fernandez I, Pumarola S, Carrascal M, Abian J, Ribas-Barba L, Serra-Majem L, Torres JL. The presence of D-fagomine in the human diet from buckwheat-based foodstuffs. Food Chem. 2013 Feb 15;136(3-4):1316-21. doi: 10.1016/j.foodchem.2012.09.038. Epub 2012 Sep 18. — View Citation
Gomez L, Molinar-Toribio E, Calvo-Torras MA, Adelantado C, Juan ME, Planas JM, Canas X, Lozano C, Pumarola S, Clapes P, Torres JL. D-Fagomine lowers postprandial blood glucose and modulates bacterial adhesion. Br J Nutr. 2012 Jun;107(12):1739-46. doi: 10.1017/S0007114511005009. Epub 2011 Oct 3. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Postprandial Glycaemic Response Index | 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. | 120 minutes | |
| Secondary | Maximum Blood Glucose Concentration (C Max) Over the Baseline | 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) |
Usually in the range of 30-45 minutes |