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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hyperglycemia

Intervention / Treatment
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* Dietary Supplement: Reduction of glycemic index of ingested foods


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brown Seaweed Lemon Tea<br>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<br>* 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.<br>* Other names: InSea2;|
| Placebo Comparator: Placebo lemon tea<br>Single administration of placebo lemon tea containing 50 g of sucrose | Dietary Supplement: Reduction of glycemic index of ingested foods<br>* 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.<br>* Other names: InSea2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and severity of Adverse Events as a Measure of Safety and Tolerability |  | First administration up to 7 days after last administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amylase, Glucosidase, Glycemic response, Sucrose, Seaweed