The Absorption and Metabolism of Seaweed Polyphenols in Humans

NCT ID: NCT02496806

Last Updated: 2015-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-12-31

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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment

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

Group Type EXPERIMENTAL

Seaweed extract

Intervention Type DIETARY_SUPPLEMENT

Treatment capsule containing seaweed extract (treatment)

Interventions

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Seaweed extract

Treatment capsule containing seaweed extract (treatment)

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Ulster

OTHER

Sponsor Role collaborator

University of Reading

OTHER

Sponsor Role lead

Responsible Party

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DR GIULIA CORONA

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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SWAFAX11/18

Identifier Type: -

Identifier Source: org_study_id

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