The Absorption and Metabolism of Seaweed Polyphenols in H... | NCT02496806

Studies
The Absorption and Metabolism of Seaweed Polyphenols in Humans

NCT02496806

Sponsor

University of Reading

Status

Completed

Last Update Posted

Jul 14, 2015Estimated

Enrollment

24Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Seaweed extract

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Jun 24, 2015

First Submission Date that Met QC Criteria

Jul 9, 2015

First Posted Date

Jul 14, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2015

Last Update Posted Date

Jul 14, 2015Estimated

Name	Class
University of Ulster	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental	400mg capsule containing seaweed extract (treatment) Intervention: Dietary Supplement: Treatment capsule containing seaweed extract (treatment)	Dietary Supplement: Seaweed extract

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Seaweed extract	Dietary Supplement	Treatment capsule containing seaweed extract (treatment)	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Seaweed polyphenol metabolites in urine		24 hours
Seaweed polyphenol metabolites in plasma		24 hours

Secondary Outcomes

Measure	Description	Time Frame
Citokine levels in plasma		24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided