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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01384110
First Posted: June 28, 2011
Last Update Posted: November 15, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
innoVactiv Inc.
  Purpose
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.

Condition Intervention Phase
Hyperglycemia Dietary Supplement: Reduction of glycemic index of ingested foods Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Efficacy of a Brown Seaweed Extract Rich in Polyphenols on Glycemic Response to Sucrose in Human

Resource links provided by NLM:


Further study details as provided by innoVactiv Inc.:

Primary Outcome Measures:
  • Significant reduction in postprandial glycemia [ Time Frame: Immediately after product administration (single use) ]
  • Significant reduction in postprandial insulinemia [ Time Frame: Immediately after product administration (single use) ]

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

Enrollment: 43
Study Start Date: June 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: InSea2

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01384110


Locations
Canada
Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)
Quebec, Canada
Sponsors and Collaborators
innoVactiv Inc.
Investigators
Principal Investigator: Patrick Couture, MD, PhD Institut des nutraceutiques et des aliments fonctionnels
  More Information

Responsible Party: innoVactiv Inc.
ClinicalTrials.gov Identifier: NCT01384110     History of Changes
Other Study ID Numbers: 2010-RD-01-CLN
First Submitted: June 13, 2011
First Posted: June 28, 2011
Last Update Posted: November 15, 2011
Last Verified: November 2011

Keywords provided by innoVactiv Inc.:
Amylase
Glucosidase
Glycemic response
Sucrose
Seaweed

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases