The Absorption and Metabolism of Seaweed Polyphenols in Humans
SWAFAX
Seaweed Derived Anti-inflammatory Agents and Antioxidants
1 other identifier
interventional
24
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started May 2011
Typical duration for not_applicable healthy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 24, 2015
CompletedFirst Posted
Study publicly available on registry
July 14, 2015
CompletedJuly 14, 2015
July 1, 2015
1.6 years
June 24, 2015
July 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Seaweed polyphenol metabolites in urine
24 hours
Seaweed polyphenol metabolites in plasma
24 hours
Secondary Outcomes (1)
Citokine levels in plasma
24 hours
Study Arms (1)
Treatment
EXPERIMENTAL400mg capsule containing seaweed extract (treatment) Intervention: Dietary Supplement: Treatment capsule containing seaweed extract (treatment)
Interventions
Eligibility Criteria
You may qualify if:
- Good general health
- Body Mass Index of 18-30 Kg/m2
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Readinglead
- University of Ulstercollaborator
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
June 24, 2015
First Posted
July 14, 2015
Study Start
May 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
July 14, 2015
Record last verified: 2015-07