Effects of Added D-fagomine on Glycaemic Responses to Sucrose

Bioglane14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Reduction of Post-prandial Glycaemic Response

Interventions

D-fagomineOTHER

Measure the changes produced on the postprandial Glycaemic response

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Reading Scientific Services Ltd.

Reading, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: 120 minutes

Secondary Outcomes

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)

Time frame: Usually in the range of 30-45 minutes

Data from ClinicalTrials.gov

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