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Determination of the PPG and Insulin Responses of Rice Alone and Rice Consumed With Sugardown™

Primary Purpose

Postprandial Hyperglycemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rice
Sugardown™
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

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

Inclusion Criteria:

  • Aged between 25-65 years.
  • Non-smoker.
  • Stable body weight within the overweight weight range for their height (BMI values > 25 kg/m2).
  • 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.
  • Participant covered by social security or a similar system.
  • 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 last week.
  • 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

    Placebo Comparator

    Experimental

    Arm Label

    3 tablets Sugardown™

    Rice only

    6 tablets Sugardown™

    Arm Description

    Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of white rice consumed with 3 tablets Sugardown™

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

    Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of white rice consumed with 6 tablets Sugardown™

    Outcomes

    Primary Outcome Measures

    Postprandial increment glucose under the area curve (iAUC)
    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

    Postprandial increment insulin under the area curve (iAUC)
    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
    February 11, 2014
    Last Updated
    December 12, 2017
    Sponsor
    Boston Therapeutics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03375398
    Brief Title
    Determination of the PPG and Insulin Responses of Rice Alone and Rice Consumed With Sugardown™
    Official Title
    Determination of the Postprandial Glucose And Insulin Responses of White Rice Alone And White Rice Consumed With Sugardown™
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2011 (Actual)
    Primary Completion Date
    June 2011 (Actual)
    Study Completion Date
    June 2011 (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 short-term postprandial blood glucose and insulin responses produced by 3 test meals containing white rice 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 blood glucose and insulin responses produced by three test meals containing white rice alone or with SUGARDOWN™ (Galactomannan) in overweight adults. In the study, subjects were their own controls. Effects of the two test meals containing SUGARDOWN™ were compared to the effects produced by test meals containing an equal-carbohydrate portion of white rice alone (the control meal). The study used a repeated-measures design, such that every subject consumed each meal on two separate occasions, completing a total of six separate test sessions. Each subject completed their test sessions on separate weekday mornings at a similar time of day, as close as possible to the time they would normally eat breakfast. SUBJECTS Ten healthy, non-smoking, overweight or obese subjects (4 females, 6 males) voluntarily participated in this study. The mean ± SD age of the subjects was 29.2 ± 3.3 yr (range: 25.6 - 36.8 yr), and their mean ± SD body mass index value was 27.3 ± 1.1 kg/m2 (range: 25.5 - 28.7 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 listed below. 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
    3 tablets Sugardown™
    Arm Type
    Experimental
    Arm Description
    Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of white rice consumed with 3 tablets Sugardown™
    Arm Title
    Rice only
    Arm Type
    Placebo Comparator
    Arm Description
    Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of white rice
    Arm Title
    6 tablets Sugardown™
    Arm Type
    Experimental
    Arm Description
    Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of white rice consumed with 6 tablets Sugardown™
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Rice
    Other Intervention Name(s)
    BTI320, PAZ320
    Intervention Description
    Test food #1: White Rice <63.0 g (dry) Jasmine rice consumed together with 250 mL water
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Sugardown™
    Other Intervention Name(s)
    BTI320, PAZ320
    Intervention Description
    Test food #2: White Rice < 63.0 g (dry) Jasmine rice + 3 Sugardown™ tablets consumed together with 250 mL water Test food #3: White Rice < 63.0 g (dry) Jasmine rice + 6 Sugardown™ tablets consumed together with 250 mL water
    Primary Outcome Measure Information:
    Title
    Postprandial increment glucose under the area curve (iAUC)
    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
    Postprandial increment insulin under the area curve (iAUC)
    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
    25 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Aged between 25-65 years. Non-smoker. Stable body weight within the overweight weight range for their height (BMI values > 25 kg/m2). 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. Participant covered by social security or a similar system. 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 last week. 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, Prof.
    Organizational Affiliation
    Human Nutrition Unit School of Molecular Bioscience, University of Sydney, Australia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Determination of the PPG and Insulin Responses of Rice Alone and Rice Consumed With Sugardown™

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