Skip to main content
OpenTrials
Completed

NCT Number: NCT02496806

The Absorption and Metabolism of Seaweed Polyphenols in Humans

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Seaweed extract

Dietary Supplement

Treatment capsule containing seaweed extract (treatment)

Primary outcomes

  1. Seaweed polyphenol metabolites in urine

    Time frame: 24 hours

  2. Seaweed polyphenol metabolites in plasma

    Time frame: 24 hours

Secondary outcomes

  1. Citokine levels in plasma

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • University of Ulster

Registry information

Official study title

Seaweed Derived Anti-inflammatory Agents and Antioxidants

Acronym: SWAFAX

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 14, 2015
Registry last updated
Jul 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.