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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00936754
Other study ID # 2005-RD-10-CLN2
Secondary ID
Status Completed
Phase Phase 1
First received July 9, 2009
Last updated January 18, 2010
Start date July 2009
Est. completion date January 2010

Study information

Verified date January 2010
Source innoVactiv Inc.
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Brown seaweed powder
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)
Placebo
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)

Locations

Country Name City State
Canada Institut des Nutraceutiques et des Aliments Fonctionnels (INAF) Quebec

Sponsors (1)

Lead Sponsor Collaborator
innoVactiv Inc.

Country where clinical trial is conducted

Canada, 

Outcome

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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