The Absorption and Metabolism of Seaweed Polyphenols in Humans (SWAFAX)

July 9, 2015 updated by: DR GIULIA CORONA, University of Reading

Seaweed Derived Anti-inflammatory Agents and Antioxidants

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
400mg capsule containing seaweed extract (treatment) Intervention: Dietary Supplement: Treatment capsule containing seaweed extract (treatment)
Dietary supplement: Seaweed extract
Treatment capsule containing seaweed extract (treatment)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Seaweed polyphenol metabolites in urine
Time Frame: 24 hours
24 hours
Seaweed polyphenol metabolites in plasma
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Citokine levels in plasma
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Reading

Collaborators

University of Ulster

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

June 24, 2015

First Submitted That Met QC Criteria

July 9, 2015

First Posted (Estimate)

July 14, 2015

Study Record Updates

Last Update Posted (Estimate)

July 14, 2015

Last Update Submitted That Met QC Criteria

July 9, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SWAFAX11/18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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