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Determination of the GI and II Values of Soft Drink and Soft Drink With Sugardown™

Primary Purpose

Postprandial Hyperglycemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sugardown™
Soft drink
Sponsored by
Boston Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postprandial Hyperglycemia focused on measuring Sugardown™, Galactomannan, Postprandial blood glucose, Insulin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged between 18-65 years.
  • Non-smoker.
  • Stable body weight within the overweight weight range for their height (BMI values 25 kg/m2 for Causcasian individuals and >23 kg/m2 for Asian individuals).
  • Normal dietary habits; not dieting or eating in an overly restrictive fashion in the past 3 months.
  • A regular pattern of low to moderate physical activity.
  • Able to fast for ≥ 10 hours the night before each test session.
  • Able to refrain from eating a legume-based evening meal or drinking alcohol the day before each test session.
  • Finds the test foods suitable for consumption within 12 minutes.
  • Not taking any treatment for anorexia, weight loss, or any form of treatment or medication likely to interfere with metabolism or dietary habits.
  • Signed the informed consent form for the study.

Exclusion Criteria:

  • Currently following a restrictive diet (low-calorie, low-carbohydrate, vegan).
  • Any clinically significant physical or mental illness.
  • Suffering from a food allergy or serious food intolerance.
  • Regularly taking prescription medication other than standard contraceptive medication.
  • Females who are currently pregnant, breast-feeding, trying to become pregnant or not using an acceptable contraceptive.
  • Participating in another clinical trial or participated in another clinical trial within the two weeks.
  • Undergoing general anaesthesia in the month prior to inclusion.
  • Subject in a situation, which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    2 tablets Sugardown™

    4 tablets Sugardown™

    Soft drink

    Arm Description

    Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of soft drink consumed with 2 tablets of Sugardown™

    Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of soft drink consumed with 4 tablets of Sugardown™

    Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of soft drink

    Outcomes

    Primary Outcome Measures

    Glycemic index of the three test meals.
    Blood samples were collected into a micro-centrifuge tube containing the anticoagulant, heparin sodium salt. Plasma glucose concentrations were measured in duplicate using a spectrophotometric centrifugal analyser employing the glucose hexokinase/glucose-6-phosphate dehydrogenase enzymatic assay.

    Secondary Outcome Measures

    Insulinemic index of the three test meals.
    Each blood sample was collected into a micro-centrifuge tube containing the anticoagulant. Plasma insulin concentrations were measured using a solid phase antibody-coated tube radioimmunoassay kit.

    Full Information

    First Posted
    December 12, 2017
    Last Updated
    December 12, 2017
    Sponsor
    Boston Therapeutics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03374501
    Brief Title
    Determination of the GI and II Values of Soft Drink and Soft Drink With Sugardown™
    Official Title
    Determination of the Glycemic and Insulinemic Index Values of Soft Drink and Two Test Meals Containing Soft Drink Consumed With Sugardown™
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2014 (Actual)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boston Therapeutics

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study was a partly controlled laboratory-based study comparing the glycemic and insulinemic indices of 3 test meals containing soft drink alone or with SUGARDOWN™ (Galactomannan) in overweight adults.
    Detailed Description
    STUDY SUMMARY This study was a partly controlled, laboratory-based study comparing the short-term postprandial glucose and insulin responses produced by three test meals containing soft drink consumed alone or with SUGARDOWN™, relative to the responses produced by an equal-carbohydrate portion of glucose solution (the reference food). The study used a repeated measures design, such that every subject consumed the reference food and each test food on two separate occasions, completing a total of eight separate test sessions. Each subject completed their test sessions on separate weekday mornings at a similar time each day, as close as possible to the time they would normally eat breakfast. SUBJECTS Ten healthy, non-smoking, overweight or obese subjects (6 females and 4 males) voluntarily participated in this study. The mean ± SD age of the subjects was 32.4 ± 10.9 yr (range: 18.7 - 55.6 yr), and their mean ± body mass index value was 27.4 ± 2.6 kg/m2 (range: 25.3 - 32.3 kg/m2). Volunteers were given detailed written and verbal information about all of the study's inclusion criteria and experimental procedures. If the volunteers decided that they would like to participate in the study, they were asked to come to the research centre on another morning, where they completed a detailed screening questionnaire that assessed their current health status and medical history. In order to participate in the study, the volunteers had to meet the inclusion criteria. All suitable volunteers that were invited to participate in the study were required to sign a detailed subject information sheet and a consent form before commencing any experimental procedures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postprandial Hyperglycemia
    Keywords
    Sugardown™, Galactomannan, Postprandial blood glucose, Insulin

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    2 tablets Sugardown™
    Arm Type
    Experimental
    Arm Description
    Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of soft drink consumed with 2 tablets of Sugardown™
    Arm Title
    4 tablets Sugardown™
    Arm Type
    Experimental
    Arm Description
    Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of soft drink consumed with 4 tablets of Sugardown™
    Arm Title
    Soft drink
    Arm Type
    Placebo Comparator
    Arm Description
    Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of soft drink
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Sugardown™
    Other Intervention Name(s)
    BTI320, PAZ320
    Intervention Description
    Test food #2: 495.0 g Sprite™ soft drink plus 2 Sugardown™ tablet consumed with 250 mL water (repeated twice) Test food #3: 495.0 g Sprite™ soft drink plus 4 Sugardown™ tablet consumed with 250 mL water (repeated twice)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Soft drink
    Other Intervention Name(s)
    Sprite™
    Intervention Description
    Test food #1: 495.0 g Sprite™ soft drink consumed with 250 mL water (repeated twice)
    Primary Outcome Measure Information:
    Title
    Glycemic index of the three test meals.
    Description
    Blood samples were collected into a micro-centrifuge tube containing the anticoagulant, heparin sodium salt. Plasma glucose concentrations were measured in duplicate using a spectrophotometric centrifugal analyser employing the glucose hexokinase/glucose-6-phosphate dehydrogenase enzymatic assay.
    Time Frame
    2 days
    Secondary Outcome Measure Information:
    Title
    Insulinemic index of the three test meals.
    Description
    Each blood sample was collected into a micro-centrifuge tube containing the anticoagulant. Plasma insulin concentrations were measured using a solid phase antibody-coated tube radioimmunoassay kit.
    Time Frame
    2 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Aged between 18-65 years. Non-smoker. Stable body weight within the overweight weight range for their height (BMI values 25 kg/m2 for Causcasian individuals and >23 kg/m2 for Asian individuals). Normal dietary habits; not dieting or eating in an overly restrictive fashion in the past 3 months. A regular pattern of low to moderate physical activity. Able to fast for ≥ 10 hours the night before each test session. Able to refrain from eating a legume-based evening meal or drinking alcohol the day before each test session. Finds the test foods suitable for consumption within 12 minutes. Not taking any treatment for anorexia, weight loss, or any form of treatment or medication likely to interfere with metabolism or dietary habits. Signed the informed consent form for the study. Exclusion Criteria: Currently following a restrictive diet (low-calorie, low-carbohydrate, vegan). Any clinically significant physical or mental illness. Suffering from a food allergy or serious food intolerance. Regularly taking prescription medication other than standard contraceptive medication. Females who are currently pregnant, breast-feeding, trying to become pregnant or not using an acceptable contraceptive. Participating in another clinical trial or participated in another clinical trial within the two weeks. Undergoing general anaesthesia in the month prior to inclusion. Subject in a situation, which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jennie Brand-Miller
    Organizational Affiliation
    School of Molecular Bioscience, University of Syndey, Australia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Determination of the GI and II Values of Soft Drink and Soft Drink With Sugardown™

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