Condition category
Nutritional, Metabolic, Endocrine
Date applied
11/08/2014
Date assigned
13/10/2014
Last edited
13/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Palmaria palmata (P. palmata) is an Irish seaweed also called dulse. It has always been consumed over the years and is generally regarded as safe. There is evidence suggesting that it can have a role in promoting health but this has not been studied formally. This study will compare normal bread with bread enriched with 5g of dulse and will note any changes in markers of health.

Who can participate?
Healthy adults.

What does the study involve?
Participants are randomly allocated to one of two groups: the treatment group (bread containing 5 g P. palmata) or the placebo group (bread without P. palmata). They have to eat 1 bread roll (230 g) per day for 28 consecutive days.

What are the possible benefits and risks of participating?
This study will help understand the effects of consuming Irish seaweed on human health. No foreseeable risks are involved.

Where is the study run from?
University of Ulster in Coleraine, Northern Ireland (UK).

When is the study starting and how long is it expected to run for?
August to December 2011.

Who is funding the study?
The Irish Marine Institute and the Department of Agriculture

Who is the main contact?
Dr Emeir McSorley
em.mcsorley@ulster.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Emeir McSorley

ORCID ID

Contact details

Room W2046
School of Biomedical Sciences
University of Ulster
Coleraine campus
Cromore Road
Coleraine
BT52 1SA
United Kingdom
+44 (0)28 7012 3543
em.mcsorley@ulster.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effect of consuming Palmaria palmata enriched bread on inflammatory markers, antioxidant status, lipid profile and thyroid function in a randomised placebo controlled intervention trial of healthy adults

Acronym

SEAPALM

Study hypothesis

Consumption of P. palmata will favourably alter biomarkers of inflammation and other markers of health (lipid profile, thyroid function and antioxidant status)

Ethics approval

Research Ethics Committee of the University of Ulster; ref: REC/11/0078

Study design

Double-blind randomized placebo controlled human dietary intervention study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Inflammation in healthy adults - cardiovascular disease risk

Intervention

Palmaria palmata incorporated (5g) into bread (230g total) vs bread alone

Participants were randomly assigned to either the treatment group (bread containing 5 g P. palmata) or placebo group (bread without P. palmata) using an online randomization software (www.randomisation.com) which was determined prior to participant recruitment. Treatment and control breads were labelled and allocated to participant ID according to the randomisation sequence output by an independent researcher not involved in the design or the analysis of the study to ensure that the study was double-blinded to both researcher and participants.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

C-reactive protein- cytokine analysis

Secondary outcome measures

1. Lipid profile - (cholesterol; triglycerides)
2. Thyroid function - (thyroid stimulating hormone (TSH))
3. Antioxidant status - (ferric reducing antioxidant power (FRAP))

Overall trial start date

01/08/2011

Overall trial end date

15/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Apparently healthy adults aged 18-65 years.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

Participants were excluded if they regularly consumed seaweed (>5 g/week), used vitamin or mineral supplements, used immune altering medication or had a history of thyroid problems.

Recruitment start date

01/08/2011

Recruitment end date

15/12/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Room W2046
Coleraine
BT52 1SA
United Kingdom

Sponsor information

Organisation

Department of Food, Agriculture and the Marine (Ireland)

Sponsor details

Agriculture House
Kildare St.
Dublin
Dublin 2
Ireland
+353 (0)1 607 2000
info@agriculture.gov.ie

Sponsor type

Government

Website

http://www.nutramara.ie

Funders

Funder type

Research organisation

Funder name

The Irish Marine Institute and the Department of Agriculture, Food and the Marine - Sea Change Strategy; Grant-Aid Agreement No. MFFRI/07/01

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes