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Safety and Efficacy of a Single Dose of a Polyphenol-enriched Brown Seaweed Powder in Human (ICAST)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00936754
First Posted: July 10, 2009
Last Update Posted: January 20, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
innoVactiv Inc.
  Purpose
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.

Condition Intervention Phase
Glycemic Index Dietary Supplement: Brown seaweed powder Dietary Supplement: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Safety and Efficacy of a Unique Dose of a Brown Seaweeds Powder Enriched in Polyphenols on Human

Further study details as provided by innoVactiv Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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) ]

Estimated Enrollment: 23
Study Start Date: July 2009
Study Completion Date: January 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Single administration of 500 mg of encapsulated brown seaweed powder, taken 30 minutes before test meal
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 Comparator: Placebo
Single administration of encapsulated placebo, taken 30 minutes before test meal
Dietary Supplement: 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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00936754


Locations
Canada
Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)
Quebec, Canada, G1V 0A6
Sponsors and Collaborators
innoVactiv Inc.
Investigators
Principal Investigator: Patrick Couture, MD, PhD Institut des nutraceutiques et des aliments fonctionnels
  More Information

Responsible Party: Jocelyn Bérubé/Scientific Director, Health & Nutrition, innoVactiv inc.
ClinicalTrials.gov Identifier: NCT00936754     History of Changes
Other Study ID Numbers: 2005-RD-10-CLN2
First Submitted: July 9, 2009
First Posted: July 10, 2009
Last Update Posted: January 20, 2010
Last Verified: January 2010

Keywords provided by innoVactiv Inc.:
Glycemic index
Reduction of glycemic index of ingested foods