Efficacy of a Brown Seaweed Extract Rich in Polyphenols on Glycemic Response to Sucrose in Human

Phase 1

Completed

• Conditions: Hyperglycemia
• Interventions: Dietary Supplement: Reduction of glycemic index of ingested foods

• Registration Number: NCT01384110
• Lead Sponsor: innoVactiv Inc.

Brief Summary

The primary endpoint of this trial will be to evaluate if a single administration in human of a lemon ice tea containing 500 mg of a polyphenol-rich algal powder is able to reduce postprandial glycemia and insulinemia.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-13
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-28
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-14
• Last Update Posted: 2011-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Healthy volunteer aged 18 to 60
• BMI between 20 and 30
• Non-smoking
• Using valid contraceptive method (women of childbearing age)

Exclusion Criteria

• Iodine allergy, or allergy to components of the test product or placebo or standard meal
• Diabetes
• Use of dietary supplements for duration of study
• History of gastro-intestinal affections, anemia, major surgeries or surgeries of the stomach or digestive tract

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo lemon tea	Reduction of glycemic index of ingested foods	Single administration of placebo lemon tea containing 50 g of sucrose
Brown Seaweed Lemon Tea	Reduction of glycemic index of ingested foods	Single administration of lemon tea containing 500 mg of brown seaweed powder and 50 g of sucrose

Primary Outcome Measures

Name	Time	Method
Significant reduction in postprandial glycemia	Immediately after product administration (single use)
Significant reduction in postprandial insulinemia	Immediately after product administration (single use)

Secondary Outcome Measures

Name	Time	Method
Frequency and severity of Adverse Events as a Measure of Safety and Tolerability	First administration up to 7 days after last administration

Trial Locations

Locations (1)

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