Safety and Efficacy of a Single Dose of a Polyphenol-enriched Brown Seaweed Powder in Human

Study Overview
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Brief Summary
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The primary endpoint of this trial will be to evaluate the safety of a single administration in human of a dose of 500 mg of a polyphenol-rich algal powder when taken 30 minutes before a test meal. The secondary endpoint of this trial will be to evaluate if a single administration in human of a dose of 500 mg of a polyphenol-rich algal powder is able to reduce the rate of carbohydrate absorption as measured by following postprandial glycemia and insulinemia.

Official Title
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Safety and Efficacy of a Unique Dose of a Brown Seaweeds Powder Enriched in Polyphenols on Human

Conditions
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Glycemic Index

Intervention / Treatment
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* Dietary Supplement: Brown seaweed powder
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteer BMI between 20 and 30 Non-smoking Exclusion Criteria: Iodine allergy Diabetes Use of dietary supplements for duration of study History of 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: Treatment<br>Single administration of 500 mg of encapsulated brown seaweed powder, taken 30 minutes before test meal | Dietary Supplement: Brown seaweed powder<br>* 500 mg (in two 250 mg capsules) taken with 250 ml of water 30 minutes before test meal (110g of plain white bread with 250 ml of water)<br>|
| Placebo Comparator: Placebo<br>Single administration of encapsulated placebo, taken 30 minutes before test meal | Dietary Supplement: Placebo<br>* Two capsules similar in aspect and weight to active product, taken with 250 ml of water 30 minutes before test meal (110g of plain white bread with 250 ml of water)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of a single 500 mg administration of a brown seaweed extract in human |  | First administration up to 7 days after last administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant reduction of glycemic index of test food |  | Immediately after product administration (single use) | 
| Significant reduction in postprandial glycemia |  | Immediately after product administration (single use) | 
| Significant reduction in postprandial insulinemia |  | Immediately after product administration (single use) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glycemic index, Reduction of glycemic index of ingested foods