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

NCT ID: NCT01384110

Last Updated: 2011-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-10-31

Brief Summary

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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

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Conditions

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Hyperglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Brown Seaweed Lemon Tea

Single administration of lemon tea containing 500 mg of brown seaweed powder and 50 g of sucrose

Group Type EXPERIMENTAL

Reduction of glycemic index of ingested foods

Intervention Type DIETARY_SUPPLEMENT

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.

Placebo lemon tea

Single administration of placebo lemon tea containing 50 g of sucrose

Group Type PLACEBO_COMPARATOR

Reduction of glycemic index of ingested foods

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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InSea2

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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innoVactiv Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick Couture, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut des nutraceutiques et des aliments fonctionnels

Locations

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Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)

Québec, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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2010-RD-01-CLN

Identifier Type: -

Identifier Source: org_study_id