Glycemic Index Clinical Trial
— ICASTOfficial title:
Safety and Efficacy of a Unique Dose of a Brown Seaweeds Powder Enriched in Polyphenols on Human
Verified date | January 2010 |
Source | innoVactiv Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 23 |
Est. completion date | January 2010 |
Est. primary completion date | November 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Healthy volunteer - BMI between 20 and 30 - Non-smoking Exclusion Criteria: - Iodine allergy - Diabetes - Use of dietary supplements for duration of study - History of major surgeries or surgeries of the stomach or digestive tract |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
Canada | Institut des Nutraceutiques et des Aliments Fonctionnels (INAF) | Quebec |
Lead Sponsor | Collaborator |
---|---|
innoVactiv Inc. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of a single 500 mg administration of a brown seaweed extract in human | First administration up to 7 days after last administration | Yes | |
Secondary | Significant reduction of glycemic index of test food | Immediately after product administration (single use) | No | |
Secondary | Significant reduction in postprandial glycemia | Immediately after product administration (single use) | No | |
Secondary | Significant reduction in postprandial insulinemia | Immediately after product administration (single use) | No |
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