HyperglycemiaPhase 1NCT01384110
Efficacy of a Brown Seaweed Extract Rich in Polyphenols on Glycemic Response to Sucrose in Human
A Phase 1 study testing Reduction of glycemic index of ingested foods in people with Hyperglycemia, run by innoVactiv Inc. at 1 site in Canada.
Trial summary
The primary endpoint of this trial will be to evaluate if a single administration in human of a lemon ice tea containing 500 mg of a polyphenol-rich algal powder is able to reduce postprandial glycemia and insulinemia. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- Reduction of glycemic index of ingested foods
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to Oct 2011
- Phase
- Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteer aged 18 to 60
- BMI between 20 and 30
- Non-smoking
- Using valid contraceptive method (women of childbearing age)
Who cannot join
- Iodine allergy, or allergy to components of the test product or placebo or standard meal
- Diabetes
- Use of dietary supplements for duration of study
- History of gastro-intestinal affections, anemia, major surgeries or surgeries of the stomach or digestive tract
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)
Québec, Quebec
About this study
The primary endpoint of this trial will be to evaluate if a single administration in human of a lemon ice tea containing 500 mg of a polyphenol-rich algal powder is able to reduce postprandial glycemia and insulinemia.
- Conditions
- Hyperglycemia
- Being tested
- Reduction of glycemic index of ingested foods
- Keywords
- Amylase, Glucosidase, Glycemic response, Sucrose, Seaweed
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduction of glycemic index of ingested foodsDietary supplement
Also called InSea2
Oral administration of the experimental lemon tea powder(56.1 g) and the placebo lemon tea powder (55.6 g) dissolved in water. Each participant will receive both treatment in a cross-over protocol design during 2 visits separated by a 2-weeks period. The day before both intervention, participants will consume a standardised meal for the supper.
| Study group | Role | What they receive |
|---|---|---|
| Brown Seaweed Lemon Tea | Experimental | Single administration of lemon tea containing 500 mg of brown seaweed powder and 50 g of sucrose Receives: Dietary Supplement: Reduction of glycemic index of ingested foods |
| Placebo lemon tea | Placebo comparator | Single administration of placebo lemon tea containing 50 g of sucrose Receives: Dietary Supplement: Reduction of glycemic index of ingested foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant reduction in postprandial glycemia
Measured: Immediately after product administration (single use)
Significant reduction in postprandial insulinemia
Measured: Immediately after product administration (single use)
Secondary outcomes (1)
Frequency and severity of Adverse Events as a Measure of Safety and Tolerability
Measured: First administration up to 7 days after last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- innoVactiv Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Couture, MD, PhD, Principal investigator, Institut des nutraceutiques et des aliments fonctionnels
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384110
- Sponsor's protocol ID
- 2010-RD-01-CLN
- Status last verified
- Nov 2011
- First submitted
- 13 Jun 2011
- Last updated
- 15 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Brown Seaweed Extract Rich in Polyphenols on Glycemic Response to Sucrose in Human
- ClinicalTrials.gov ID
- NCT01384110
- Acronym / sponsor ID
- 2010-RD-01-CLN
- Conditions
- Hyperglycemia
- Keywords
- Amylase, Glucosidase, Glycemic response, Sucrose, Seaweed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- innoVactiv Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 28 Jun 2011 (estimated)
- 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.
The primary endpoint of this trial will be to evaluate if a single administration in human of a lemon ice tea containing 500 mg of a polyphenol-rich algal powder is able to reduce postprandial glycemia and insulinemia.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brown Seaweed Lemon Tea | Experimental | Dietary Supplement: Reduction of glycemic index of ingested foodsSingle administration of lemon tea containing 500 mg of brown seaweed powder and 50 g of sucrose |
| Placebo lemon tea | Placebo comparator | Dietary Supplement: Reduction of glycemic index of ingested foodsSingle administration of placebo lemon tea containing 50 g of sucrose |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteer aged 18 to 60
- BMI between 20 and 30
- Non-smoking
- Using valid contraceptive method (women of childbearing age)
Key exclusion criteria (4 listed)
- Iodine allergy, or allergy to components of the test product or placebo or standard meal
- Diabetes
- Use of dietary supplements for duration of study
- History of gastro-intestinal affections, anemia, major surgeries or surgeries of the stomach or digestive tract
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 |
|---|---|---|
| Reduction of glycemic index of ingested foodsAlso: InSea2Oral administration of the experimental lemon tea powder(56.1 g) and the placebo lemon tea powder (55.6 g) dissolved in water. Each participant will receive both treatment in a cross-over protocol design during 2 visits separated by a 2-weeks period. The day before both intervention, participants will consume a standardised meal for the supper. | Dietary supplement | Brown Seaweed Lemon Tea, Placebo lemon tea |
Primary outcome
Significant reduction in postprandial glycemia
Time frame: Immediately after product administration (single use)
Significant reduction in postprandial insulinemia
Time frame: Immediately after product administration (single use)
1 secondary outcome
Frequency and severity of Adverse Events as a Measure of Safety and Tolerability
Time frame: First administration up to 7 days after last administration
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 Nov 2011.
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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.
Patrick Couture, MD, PhD principal investigator
Institut des nutraceutiques et des aliments fonctionnels
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Reduction of glycemic index of ingested foods in people with Hyperglycemia, run by innoVactiv Inc. at 1 site in Canada.
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 4 inclusion and 4 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 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Significant reduction in postprandial glycemia (time frame: Immediately after product administration (single use)). The study lists 2 primary outcomes in all. 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 Nov 2011.