Effects of Added D-fagomine on Glycaemic Responses to Sucrose

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Effects of Added D-fagomine on Glycaemic Responses to Sucrose

Conditions
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Reduction of Post-prandial Glycaemic Response

Intervention / Treatment
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* Other: D-fagomine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: D-fagomine<br>Measure the changes produced on the postprandial Glycaemic response to 50 g of sucrose containing 40 mg D-fagomine, in 200 ml water | Other: D-fagomine<br>* Measure the changes produced on the postprandial Glycaemic response<br>|
| Placebo Comparator: Control<br>Sucrose 50 g without d-fagomine, in 200 ml water | Other: D-fagomine<br>* Measure the changes produced on the postprandial Glycaemic response<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |