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
About this trial
This is an interventional supportive care trial for Postprandial Hyperglycemia focused on measuring SUGARDOWN™, Galactomannan, Postprandial blood glucose, Insulin
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.
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
NCT ID
NCT03375398
First Posted
February 11, 2014
Last Updated
December 12, 2017
Sponsor
Boston Therapeutics
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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