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Effects of Added D-fagomine on Glycaemic Responses to Sucrose

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ClinicalTrials.gov Identifier: NCT01811303
Recruitment Status : Completed
First Posted : March 14, 2013
Results First Posted : July 2, 2013
Last Update Posted : July 2, 2013
Sponsor:
Information provided by (Responsible Party):
Bioglane

Study Description
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Brief Summary:
The purpose of this study is to determine whether D-fagomine affects glycaemic responses to sucrose (commercial white sugar)and quantify the response

Condition or disease Intervention/treatment Phase
Reduction of Post-prandial Glycaemic Response Other: D-fagomine Not Applicable

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of Added D-fagomine on Glycaemic Responses to Sucrose
Study Start Date : September 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Sucrose

Arms and Interventions
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Arm Intervention/treatment
Experimental: D-fagomine
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
Measure the changes produced on the postprandial Glycaemic response to 50 g of sucrose in 200 ml water if added 40 mg D-fagomine
Placebo Comparator: Control
Sucrose 50 g without d-fagomine, in 200 ml water


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811303


Locations
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United Kingdom
Reading Scientific Services Ltd.
Reading, United Kingdom, RG6 6LA
Sponsors and Collaborators
Bioglane
Investigators
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Principal Investigator: Rungano Munyuki Reading Scientific Services Ltd.
More Information
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Publications:

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Responsible Party: Bioglane
ClinicalTrials.gov Identifier: NCT01811303    
Other Study ID Numbers: RSSL SSID P12-06545
First Posted: March 14, 2013    Key Record Dates
Results First Posted: July 2, 2013
Last Update Posted: July 2, 2013
Last Verified: April 2013