Determination of the PPG and Insulin Responses of Rice Alone and Rice Consumed With Sugardown™
NCT ID: NCT03375398
Last Updated: 2017-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2011-03-31
2011-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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3 tablets Sugardown™
Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of white rice consumed with 3 tablets Sugardown™
Sugardown™
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
Rice only
Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of white rice
Rice
Test food #1: White Rice \<63.0 g (dry) Jasmine rice consumed together with 250 mL water
6 tablets Sugardown™
Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of white rice consumed with 6 tablets Sugardown™
Sugardown™
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
Interventions
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Rice
Test food #1: White Rice \<63.0 g (dry) Jasmine rice consumed together with 250 mL water
Sugardown™
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
25 Years
65 Years
ALL
Yes
Sponsors
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Boston Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Jennie Brand-Miller, Prof.
Role: PRINCIPAL_INVESTIGATOR
Human Nutrition Unit School of Molecular Bioscience, University of Sydney, Australia
Other Identifiers
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PAZ320-001
Identifier Type: -
Identifier Source: org_study_id