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

November 14, 2011 updated by: innoVactiv Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brown Seaweed Lemon Tea
Single administration of lemon tea containing 500 mg of brown seaweed powder and 50 g of sucrose
Dietary supplement: Reduction of glycemic index of ingested foods
Oral administration of the experimental lemon tea powder(56.1 g) and the placebo lemon tea powder (55.6 g) dissolved in water. Each participant will receive both treatment in a cross-over protocol design during 2 visits separated by a 2-weeks period. The day before both intervention, participants will consume a standardised meal for the supper.
Other Names:
  • InSea2
Placebo Comparator: Placebo lemon tea
Single administration of placebo lemon tea containing 50 g of sucrose
Dietary supplement: Reduction of glycemic index of ingested foods
Oral administration of the experimental lemon tea powder(56.1 g) and the placebo lemon tea powder (55.6 g) dissolved in water. Each participant will receive both treatment in a cross-over protocol design during 2 visits separated by a 2-weeks period. The day before both intervention, participants will consume a standardised meal for the supper.
Other Names:
  • InSea2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Significant reduction in postprandial glycemia
Time Frame: Immediately after product administration (single use)
Immediately after product administration (single use)
Significant reduction in postprandial insulinemia
Time Frame: Immediately after product administration (single use)
Immediately after product administration (single use)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

innoVactiv Inc.

Investigators

  • Principal Investigator: Patrick Couture, MD, PhD, Institut des nutraceutiques et des aliments fonctionnels

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

June 13, 2011

First Submitted That Met QC Criteria

June 27, 2011

First Posted (Estimate)

June 28, 2011

Study Record Updates

Last Update Posted (Estimate)

November 15, 2011

Last Update Submitted That Met QC Criteria

November 14, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-RD-01-CLN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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