Postprandial HyperglycemiaNCT03374501
Determination of the GI and II Values of Soft Drink and Soft Drink With Sugardown™
A study testing Sugardown™ and Soft drink in people with Postprandial Hyperglycemia, run by Boston Therapeutics.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Hyperglycemia
- What is being tested?
- Sugardown™ and Soft drink
- 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
- Nov 2014to Dec 2014
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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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.
- 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 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.
About this study
Official title: Determination of the Glycemic and Insulinemic Index Values of Soft Drink and Two Test Meals Containing Soft Drink Consumed With Sugardown™
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.
Read the 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.
- Conditions
- Postprandial Hyperglycemia
- Being tested
- Sugardown™, Soft drink
- 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.
Sugardown™Dietary supplement
Also called BTI320, PAZ320
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)
Soft drinkDietary supplement
Also called Sprite™
Test food #1: 495.0 g Sprite™ soft drink consumed with 250 mL water (repeated twice)
| Study group | Role | What they receive |
|---|---|---|
| 2 tablets Sugardown™ | Experimental | Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of soft drink consumed with 2 tablets of Sugardown™ Receives: Dietary Supplement: Sugardown™ |
| 4 tablets Sugardown™ | Experimental | Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of soft drink consumed with 4 tablets of Sugardown™ Receives: Dietary Supplement: Sugardown™ |
| Soft drink | Placebo comparator | Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of soft drink Receives: Dietary Supplement: Soft drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 days
Secondary outcomes (1)
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.
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 posted15 Dec 2017
- Study startNov 2014
- Primary completionDec 2014
- Study completionDec 2014
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, Principal investigator, School of Molecular Bioscience, University of Syndey, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374501
- Sponsor's protocol ID
- PAZ320-004
- Status last verified
- Dec 2017
- First submitted
- 12 Dec 2017
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Glycemic and Insulinemic Index Values of Soft Drink and Two Test Meals Containing Soft Drink Consumed With Sugardown™
- ClinicalTrials.gov ID
- NCT03374501
- Acronym / sponsor ID
- PAZ320-004
- 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
- Nov 2014 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 tablets Sugardown™ | Experimental | Dietary Supplement: Sugardown™Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of soft drink consumed with 2 tablets of Sugardown™ |
| 4 tablets Sugardown™ | Experimental | Dietary Supplement: Sugardown™Repeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of soft drink consumed with 4 tablets of Sugardown™ |
| Soft drink | Placebo comparator | Dietary Supplement: Soft drinkRepeated-measures, open cross-over design: 10 subjects consumed three different test meals comprising of soft drink |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| Sugardown™Also: BTI320, PAZ320Test 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) | Dietary supplement | 2 tablets Sugardown™, 4 tablets Sugardown™ |
| Soft drinkAlso: Sprite™Test food #1: 495.0 g Sprite™ soft drink consumed with 250 mL water (repeated twice) | Dietary supplement | Soft drink |
Primary outcome
Glycemic index of the three test meals.
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
Insulinemic index of the three test meals.
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 15 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 principal investigator
School of Molecular Bioscience, University of Syndey, Australia
Questions about this trial
What is this clinical trial studying?
A study testing Sugardown™ and Soft drink 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 10 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 15 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?
Glycemic index of the three test meals. (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 15 Dec 2017.