Efficacy of a Brown Seaweed Extract Rich in Polyphenols on Glycemic Response to Sucrose in Human
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- innoVactiv Inc.
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Significant reduction in postprandial glycemia
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •Use of dietary supplements for duration of study
- •History of gastro-intestinal affections, anemia, major surgeries or surgeries of the stomach or digestive tract
Arms & Interventions
Brown Seaweed Lemon Tea
Single administration of lemon tea containing 500 mg of brown seaweed powder and 50 g of sucrose
Intervention: Reduction of glycemic index of ingested foods (Dietary Supplement)
Placebo lemon tea
Single administration of placebo lemon tea containing 50 g of sucrose
Intervention: Reduction of glycemic index of ingested foods (Dietary Supplement)
Outcomes
Primary Outcomes
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 Outcomes
- Frequency and severity of Adverse Events as a Measure of Safety and Tolerability(First administration up to 7 days after last administration)