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

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.

Study Overview

• Status: Completed
• Conditions: Glycemic Index
• Intervention / Treatment: Dietary supplement: Brown seaweed powder; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 0A6
    • Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety of a single 500 mg administration of a brown seaweed extract in human	First administration up to 7 days after last administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Significant reduction of glycemic index of test food	Immediately after product administration (single use)
Significant reduction in postprandial glycemia	Immediately after product administration (single use)
Significant reduction in postprandial insulinemia	Immediately after product administration (single use)

Collaborators and Investigators

• Sponsor: innoVactiv Inc.
• Investigators: Principal Investigator: Patrick Couture, MD, PhD, Institut des nutraceutiques et des aliments fonctionnels

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: July 9, 2009
• First Submitted That Met QC Criteria: July 9, 2009
• First Posted (Estimate): July 10, 2009

Study Record Updates

• Last Update Posted (Estimate): January 20, 2010
• Last Update Submitted That Met QC Criteria: January 18, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: Glycemic index; Reduction of glycemic index of ingested foods
• Other Study ID Numbers: 2005-RD-10-CLN2