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

Glycemic Index Clinical Trial

— ICAST  

Official title:

Safety and Efficacy of a Unique Dose of a Brown Seaweeds Powder Enriched in Polyphenols on Human

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00936754
• Other study ID #: 2005-RD-10-CLN2
• 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

• Glycemic Index

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