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

Phase 1

Completed

• Conditions: Glycemic Index
• Interventions: Dietary Supplement: Brown seaweed powder; Dietary Supplement: Placebo

• Registration Number: NCT00936754
• Lead Sponsor: innoVactiv Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-09
• Study First Submitted QC: 2009-07-09
• Study First Posted: 2009-07-10
• Primary Completion: 2009-11
• Status Verified: 2010-01
• Study Completion: 2010-01
• Last Update Submitted: 2010-01-18
• Last Update Posted: 2010-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment	Brown seaweed powder	Single administration of 500 mg of encapsulated brown seaweed powder, taken 30 minutes before test meal
Placebo	Placebo	Single administration of encapsulated placebo, taken 30 minutes before test meal

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Institut des Nutraceutiques et des Aliments Fonctionnels (INAF); 🇨🇦 Quebec, Canada