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
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