Efficacy of a Brown Seaweed Extract Rich in Polyphenols on Glycemic Response to Sucrose in Human
Phase 1
Completed
- Conditions
- Hyperglycemia
- Registration Number
- NCT01384110
- Lead Sponsor
- innoVactiv Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Significant reduction in postprandial glycemia Immediately after product administration (single use) Significant reduction in postprandial insulinemia Immediately after product administration (single use)
- Secondary Outcome Measures
Name Time Method Frequency and severity of Adverse Events as a Measure of Safety and Tolerability First administration up to 7 days after last administration
Trial Locations
- Locations (1)
Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)
🇨🇦Quebec, Canada
Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)🇨🇦Quebec, Canada