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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:
Information provided by (Responsible Party):
innoVactiv Inc.
ClinicalTrials.gov Identifier:
NCT01384110
First received: June 13, 2011
Last updated: November 14, 2011
Last verified: November 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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:

Drug Information available for: Sucrose
U.S. FDA Resources

Further study details as provided by innoVactiv Inc.:

Primary Outcome Measures:
  • Significant reduction in postprandial glycemia [ Time Frame: Immediately after product administration (single use) ] [ Designated as safety issue: No ]
  • Significant reduction in postprandial insulinemia [ Time Frame: Immediately after product administration (single use) ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: innoVactiv Inc.
ClinicalTrials.gov Identifier: NCT01384110     History of Changes
Other Study ID Numbers: 2010-RD-01-CLN
Study First Received: June 13, 2011
Last Updated: November 14, 2011
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 21, 2013