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

This study has been completed.
Sponsor:
Information provided by:
innoVactiv Inc.
ClinicalTrials.gov Identifier:
NCT00936754
First received: July 9, 2009
Last updated: January 18, 2010
Last verified: January 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Significant reduction of glycemic index of test food [ Time Frame: Immediately after product administration (single use) ] [ Designated as safety issue: No ]
  • Significant reduction in postprandial glycemia [ Time Frame: Immediately after product administration (single use) ] [ Designated as safety issue: No ]
  • Significant reduction in postprandial insulinemia [ Time Frame: Immediately after product administration (single use) ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 9, 2009
Last Updated: January 18, 2010
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on April 22, 2014