Glycemic IndexPhase 1ICASTNCT00936754
Safety and Efficacy of a Single Dose of a Polyphenol-enriched Brown Seaweed Powder in Human
A Phase 1 study testing Brown seaweed powder in people with Glycemic Index, run by innoVactiv Inc. at 1 site in Canada.
Trial summary
The primary endpoint of this trial will be to evaluate the safety of a single administration in human of a dose of 500 mg of a polyphenol-rich algal powder when taken 30 minutes before a test meal. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Index
- What is being tested?
- Brown seaweed powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2009to Jan 2010
- 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
- BMI between 20 and 30
- Non-smoking
Who cannot join
- Iodine allergy
- Diabetes
- Use of dietary supplements for duration of study
- History of 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, G1V 0A6
About this study
Official title: Safety and Efficacy of a Unique Dose of a Brown Seaweeds Powder Enriched in Polyphenols on Human
The primary endpoint of this trial will be to evaluate the safety of a single administration in human of a dose of 500 mg of a polyphenol-rich algal powder when taken 30 minutes before a test meal. The secondary endpoint of this trial will be to evaluate if a single administration in human of a dose of 500 mg of a polyphenol-rich algal powder is able to reduce the rate of carbohydrate absorption as measured by following postprandial glycemia and insulinemia.
- Conditions
- Glycemic Index
- Being tested
- Brown seaweed powder, Placebo
- Keywords
- Glycemic index, Reduction of glycemic index of ingested foods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brown seaweed powderDietary supplement
500 mg (in two 250 mg capsules) taken with 250 ml of water 30 minutes before test meal (110g of plain white bread with 250 ml of water)
PlaceboDietary supplement
Two capsules similar in aspect and weight to active product, taken with 250 ml of water 30 minutes before test meal (110g of plain white bread with 250 ml of water)
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Single administration of 500 mg of encapsulated brown seaweed powder, taken 30 minutes before test meal Receives: Dietary Supplement: Brown seaweed powder |
| Placebo | Placebo comparator | Single administration of encapsulated placebo, taken 30 minutes before test meal Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of a single 500 mg administration of a brown seaweed extract in human
Measured: First administration up to 7 days after last administration
Secondary outcomes (3)
Significant reduction of glycemic index of test food
Measured: Immediately after product administration (single use)
Significant reduction in postprandial glycemia
Measured: Immediately after product administration (single use)
Significant reduction in postprandial insulinemia
Measured: Immediately after product administration (single use)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionNov 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic IndexStudies 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
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- innoVactiv Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Patrick Couture, MD, PhD, Principal investigator, Institut des nutraceutiques et des aliments fonctionnels
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936754
- Sponsor's protocol ID
- 2005-RD-10-CLN2
- Acronym
- ICAST
- Status last verified
- Jan 2010
- First submitted
- 9 Jul 2009
- Last updated
- 20 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a Unique Dose of a Brown Seaweeds Powder Enriched in Polyphenols on Human
- ClinicalTrials.gov ID
- NCT00936754
- Acronym / sponsor ID
- ICAST / 2005-RD-10-CLN2
- Conditions
- Glycemic Index
- Keywords
- Glycemic index, Reduction of glycemic index of ingested foods
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- innoVactiv Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 10 Jul 2009 (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 the safety of a single administration in human of a dose of 500 mg of a polyphenol-rich algal powder when taken 30 minutes before a test meal. The secondary endpoint of this trial will be to evaluate if a single administration in human of a dose of 500 mg of a polyphenol-rich algal powder is able to reduce the rate of carbohydrate absorption as measured by following 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 |
|---|---|---|
| Treatment | Experimental | Dietary Supplement: Brown seaweed powderSingle administration of 500 mg of encapsulated brown seaweed powder, taken 30 minutes before test meal |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSingle administration of encapsulated placebo, taken 30 minutes before test meal |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy volunteer
- BMI between 20 and 30
- Non-smoking
Key exclusion criteria (4 listed)
- Iodine allergy
- Diabetes
- Use of dietary supplements for duration of study
- History of 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 |
|---|---|---|
| Brown seaweed powder500 mg (in two 250 mg capsules) taken with 250 ml of water 30 minutes before test meal (110g of plain white bread with 250 ml of water) | Dietary supplement | Treatment |
| PlaceboTwo capsules similar in aspect and weight to active product, taken with 250 ml of water 30 minutes before test meal (110g of plain white bread with 250 ml of water) | Dietary supplement | Placebo |
Primary outcome
Safety of a single 500 mg administration of a brown seaweed extract in human
Time frame: First administration up to 7 days after last administration
3 secondary outcomes
Significant reduction of glycemic index of test food
Time frame: Immediately after product administration (single use)
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)
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 20 Jan 2010.
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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 Brown seaweed powder in people with Glycemic Index, 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 3 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 20 Jan 2010. 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?
Safety of a single 500 mg administration of a brown seaweed extract in human (time frame: First administration up to 7 days after last administration). 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 20 Jan 2010.