Postprandial HyperglycemiaNCT03375398
Determination of the PPG and Insulin Responses of Rice Alone and Rice Consumed With Sugardown™
A study testing Rice and Sugardown™ in people with Postprandial Hyperglycemia, run by Boston Therapeutics.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Hyperglycemia
- What is being tested?
- Rice and Sugardown™
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
About this study
Official title: Determination of the Postprandial Glucose And Insulin Responses of White Rice Alone And White Rice Consumed With Sugardown™
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.
Read the 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.
- Conditions
- Postprandial Hyperglycemia
- Being tested
- Rice, Sugardown™
- Keywords
- SUGARDOWN™, Galactomannan, Postprandial blood glucose, Insulin
- Medical subject headings
- Hyperglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RiceDietary supplement
Also called BTI320, PAZ320
Test food #1: White Rice <63.0 g (dry) Jasmine rice consumed together with 250 mL water
Sugardown™Dietary supplement
Also called BTI320, PAZ320
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
| Study group | Role | What they receive |
|---|---|---|
| 3 tablets Sugardown™ | Experimental | Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of white rice consumed with 3 tablets Sugardown™ Receives: Dietary Supplement: Sugardown™ |
| Rice only | Placebo comparator | Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of white rice Receives: Dietary Supplement: Rice |
| 6 tablets Sugardown™ | Experimental | Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of white rice consumed with 6 tablets Sugardown™ Receives: Dietary Supplement: Sugardown™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 days
Secondary outcomes (1)
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.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study startMar 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial HyperglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennie Brand-Miller, Prof., Principal investigator, Human Nutrition Unit School of Molecular Bioscience, University of Sydney, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375398
- Sponsor's protocol ID
- PAZ320-001
- Status last verified
- Dec 2017
- First submitted
- 11 Feb 2014
- Last updated
- 18 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Postprandial Glucose And Insulin Responses of White Rice Alone And White Rice Consumed With Sugardown™
- ClinicalTrials.gov ID
- NCT03375398
- Acronym / sponsor ID
- PAZ320-001
- Conditions
- Postprandial Hyperglycemia
- Keywords
- SUGARDOWN™, Galactomannan, Postprandial blood glucose, Insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Boston TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2011 (actual)
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 18 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3 tablets Sugardown™ | Experimental | Dietary Supplement: Sugardown™Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of white rice consumed with 3 tablets Sugardown™ |
| Rice only | Placebo comparator | Dietary Supplement: RiceRepeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of white rice |
| 6 tablets Sugardown™ | Experimental | Dietary Supplement: Sugardown™Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of white rice consumed with 6 tablets Sugardown™ |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RiceAlso: BTI320, PAZ320Test food #1: White Rice <63.0 g (dry) Jasmine rice consumed together with 250 mL water | Dietary supplement | Rice only |
| Sugardown™Also: BTI320, PAZ320Test 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 | Dietary supplement | 3 tablets Sugardown™, 6 tablets Sugardown™ |
Primary outcome
Postprandial increment glucose under the area curve (iAUC)
Time frame: 2 days
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.
1 secondary outcome
Postprandial increment insulin under the area curve (iAUC)
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennie Brand-Miller, Prof. principal investigator
Human Nutrition Unit School of Molecular Bioscience, University of Sydney, Australia
Questions about this trial
What is this clinical trial studying?
A study testing Rice and Sugardown™ in people with Postprandial Hyperglycemia, run by Boston Therapeutics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial increment glucose under the area curve (iAUC) (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2017.