The Absorption and Metabolism of Seaweed Polyphenols in Humans (NCT02496806) | Clinical Trial Compass
CompletedNot Applicable
The Absorption and Metabolism of Seaweed Polyphenols in Humans
24 participantsStarted 2011-05
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.