HealthySWAFAXNCT02496806
The Absorption and Metabolism of Seaweed Polyphenols in Humans
A study testing Seaweed extract in people with Healthy, run by University of Reading.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Seaweed extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Good general health
- Body Mass Index of 18-30 Kg/m2
Who cannot join
- Inability to swallow capsules
- Smoking
- Alcohol intake of >21 units/wk
- Blood pressure > 150/90 mmHg
- Any dietary restrictions or weight reducing diet
- Vegetarian
Show all 20Show fewer
- 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
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Seaweed extract
- Keywords
- Polyphenols, Absorption, Metabolism, Phlorotannins, Seaweeds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seaweed extractDietary supplement
Treatment capsule containing seaweed extract (treatment)
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 400mg capsule containing seaweed extract (treatment) Intervention: Dietary Supplement: Treatment capsule containing seaweed extract (treatment) Receives: Dietary Supplement: Seaweed extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seaweed polyphenol metabolites in urine
Measured: 24 hours
Seaweed polyphenol metabolites in plasma
Measured: 24 hours
Secondary outcomes (1)
Citokine levels in plasma
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startMay 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ulster
- Responsible party
- Principal investigator, DR GIULIA CORONA, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496806
- Sponsor's protocol ID
- SWAFAX11/18
- Acronym
- SWAFAX
- Status last verified
- Jul 2015
- First submitted
- 24 Jun 2015
- Last updated
- 14 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seaweed Derived Anti-inflammatory Agents and Antioxidants
- ClinicalTrials.gov ID
- NCT02496806
- Acronym / sponsor ID
- SWAFAX / SWAFAX11/18
- Conditions
- Healthy
- Keywords
- Polyphenols, Absorption, Metabolism, Phlorotannins, Seaweeds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- University of Ulster
- Study start
- May 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 14 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Dietary Supplement: Seaweed extract400mg capsule containing seaweed extract (treatment) Intervention: Dietary Supplement: Treatment capsule containing seaweed extract (treatment) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Good general health
- Body Mass Index of 18-30 Kg/m2
Key exclusion criteria (20 listed)
- Inability to swallow capsules
- Smoking
- Alcohol intake of >21 units/wk
- Blood pressure > 150/90 mmHg
- Any dietary restrictions or weight reducing diet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seaweed extractTreatment capsule containing seaweed extract (treatment) | Dietary supplement | Treatment |
Primary outcome
Seaweed polyphenol metabolites in urine
Time frame: 24 hours
Seaweed polyphenol metabolites in plasma
Time frame: 24 hours
1 secondary outcome
Citokine levels in plasma
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Seaweed extract in people with Healthy, run by University of Reading.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seaweed polyphenol metabolites in urine (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2015.