The Absorption and Metabolism of Seaweed Polyphenols in Humans

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Seaweed extract

• Registration Number: NCT02496806
• Lead Sponsor: University of Reading

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2015-06-24
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-09
• Last Update Submitted: 2015-07-09
• Study First Posted: 2015-07-14
• Last Update Posted: 2015-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Seaweed extract	400mg capsule containing seaweed extract (treatment) Intervention: Dietary Supplement: Treatment capsule containing seaweed extract (treatment)

Primary Outcome Measures

Name	Time	Method
Seaweed polyphenol metabolites in plasma	24 hours
Seaweed polyphenol metabolites in urine	24 hours

Secondary Outcome Measures

Name	Time	Method
Citokine levels in plasma	24 hours