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

Hyperglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01384110
• Other study ID #: 2010-RD-01-CLN
• Status: Completed
• Phase: Phase 1
• First received: June 13, 2011
• Last updated: November 14, 2011
• Start date: June 2011
• Est. completion date: October 2011

Study information

• Verified date: November 2011
• Source: innoVactiv Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Hyperglycemia

Intervention

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.

Locations

Country	Name	City	State
Canada	Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
innoVactiv Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant reduction in postprandial glycemia		Immediately after product administration (single use)	No
Primary	Significant reduction in postprandial insulinemia		Immediately after product administration (single use)	No
Secondary	Frequency and severity of Adverse Events as a Measure of Safety and Tolerability		First administration up to 7 days after last administration	Yes