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The purpose of this study is to determine whether D-fagomine affects glycaemic responses to sucrose (commercial white sugar)and quantify the response
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-fagomine | Experimental | Measure the changes produced on the postprandial Glycaemic response to 50 g of sucrose containing 40 mg D-fagomine, in 200 ml water |
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| Control | Placebo Comparator | Sucrose 50 g without d-fagomine, in 200 ml water |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-fagomine | Other | Measure the changes produced on the postprandial Glycaemic response |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rungano Munyuki | Reading Scientific Services Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reading Scientific Services Ltd. | Reading | RG6 6LA | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22017795 | Background | 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. | |
| 23194529 | Background |
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There was 15 subjects screened that all were complying with the eligibility criteria. Finally only 14 subjects were involved in the study and analysed as far the study was planned to involve 12 subjects. All 14 subjects received the treatment randomized to a William's Latin square design balanced for treatment order.
Recruitment of adults volunteers done by RSSL, in Reading (United Kingdom), under GCP.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo, Placebo, Treatment, Treatment | The subjects receive placebo in the first two interventions. |
| FG001 | Treatment, Treatment, Placebo, Placebo | The subjects receive treatment in the first two interventions |
| FG002 | Placebo, Treatment, Placebo, Treatment | The subjects receive placebo or treatment in each intervention alternatively, starting with placebo. |
| FG003 | Treatment, Placebo, Treatment, Placebo | The subjects receive placebo or treatment in each intervention alternatively, starting with treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Day) |
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| Washout (2 Days or More) |
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| Second Intervention (1 Day) |
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| Washout (2 Days or More) |
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| Third Intervention (1 Day) |
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| Washout (2 Days or More) |
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| Fourth Intervention (1 Day) |
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| ID | Title | Description |
|---|---|---|
| BG000 | D-fagomine (All Study Participants) | Measure the changes produced on the postprandial Glycaemic response to 50 g of sucrose containing 40 mg D-fagomine, in 200 ml water vs placebo. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The number of participants >10, the repetitions >= 2 and also other variables was determined based on F. Brouns et al., Glycaemic index methodology,Nutrition Research Reviews (2005), 18, 145-171. Also was considered the advice and previous GI studies from RSSL based on master protocol GIMST09. | Posted | Mean | 95% Confidence Interval | percentage of AUC fagomine/AUC control | 120 minutes |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | D-fagomine (All Study Participants) | Measure the changes produced on the postprandial Glycaemic response to 50 g of sucrose containing 40 mg D-fagomine, in 200 ml water. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rungano Munyuki (Clinical Project Manager) | RSSL | 0118 9184034 |
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| ID | Term |
|---|---|
| C105643 | fagomine |
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| 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. |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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) | Posted | Mean | Standard Error | mmol/L | Usually in the range of 30-45 minutes |
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| 14 |
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| 14 |
| EG001 | Placebo - Control (All Study Participants) | Measure the changes produced on the postprandial Glycaemic response to 50 g sucrose in 200 ml water (without d-fagomine) | 0 | 14 | 0 | 14 |
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