Reading Scientific Services Ltd.
Reading, RG6 6LA, United Kingdom
Completed
NCT Number: NCT01811303
Effects of Added D-fagomine on Glycaemic Responses to Sucrose
The purpose of this study is to determine whether D-fagomine affects glycaemic responses to sucrose (commercial white sugar)and quantify the response
Completed
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Notify MeKey information
Age range
18 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
D-Fagomine
OtherMeasure the changes produced on the postprandial Glycaemic response
Primary outcomes
-
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.
Secondary outcomes
-
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)
Sponsors and collaborators
Lead sponsor
Bioglane
Industry
Registry information
Important dates
- Study start
- 2012
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Mar 14, 2013
- Registry last updated
- Sep 18, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.