The Absorption and Metabolism of Seaweed Polyphenols in Humans

Study Overview
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Brief Summary
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Brown seaweeds are a rich source of phlorotannins, a characteristic class of polyphenols which are unique to seaweeds of this type and can comprise 5 to 15 % of the dried weight. Unlike other classes of polyphenols, there is a lack of knowledge regarding phlorotannins and their bioavailability and bioactivity. The purpose of this study is to investigate the absorption and metabolism of seaweed polyphenols in humans. As part of an EC project (SWAFAX), an acute clinical intervention will be conducted to investigate the metabolism/ bioavailability of brown seaweed phlorotannins. Urine and plasma samples from 24 healthy volunteers that consumed a seaweed capsule containing polyphenols will be collected before and after the intervention. Data emanating from this project will provide strong scientific evidence for bioavailability and health promoting activity of a seaweed polyphenol extract in human volunteers.

Official Title
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Seaweed Derived Anti-inflammatory Agents and Antioxidants

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Seaweed extract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Good general health Body Mass Index of 18-30 Kg/m2 Exclusion Criteria: Inability to swallow capsules Smoking Alcohol intake of >21 units/wk Blood pressure > 150/90 mmHg Any dietary restrictions or weight reducing diet Vegetarian Heamoglobin levels< 125 g/l for male, < 110 g/l for female, Gamma GT levels > 80 IU/l Cholesterol levels > 6.5 mmol/l Myocardial infarction or stroke in the previous 12 months Gastrointestinal disease or chronic gastrointestinal disorders Reproductive disorder Blood-clotting disorder Metabolic disorders Lipid-modifying medication Blood clotting mdication Antibiotic medication in previous 3 months before study Lactation Pregnancy Females of childbearing potential and not using effective contraceptive precautions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>400mg capsule containing seaweed extract (treatment) Intervention: Dietary Supplement: Treatment capsule containing seaweed extract (treatment) | Dietary Supplement: Seaweed extract<br>* Treatment capsule containing seaweed extract (treatment)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seaweed polyphenol metabolites in urine |  | 24 hours | 
| Seaweed polyphenol metabolites in plasma |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Citokine levels in plasma |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polyphenols, Absorption, Metabolism, Phlorotannins, Seaweeds