The effect of consuming dulse enriched bread on markers of health

ISRCTN	ISRCTN34271192
DOI	https://doi.org/10.1186/ISRCTN34271192
Secondary identifying numbers	N/A

Submission date: 11/08/2014
Registration date: 13/10/2014
Last edited: 19/05/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Emeir McSorley
Scientific

Room W2046
School of Biomedical Sciences
University of Ulster
Coleraine campus
Cromore Road
Coleraine
BT52 1SA
United Kingdom

Phone	+44 (0)28 7012 3543
Email	em.mcsorley@ulster.ac.uk

Study information

Study design	Double-blind randomized placebo controlled human dietary intervention study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	SEAPALM
Study objectives	Consumption of P. palmata will favourably alter biomarkers of inflammation and other markers of health (lipid profile, thyroid function and antioxidant status)
Ethics approval(s)	Research Ethics Committee of the University of Ulster; ref: REC/11/0078
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/08/2011
Completion date	15/12/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	40
Key inclusion criteria	Apparently healthy adults aged 18-65 years.
Key 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.
Date of first enrolment	01/08/2011
Date of final enrolment	15/12/2011

Locations

Countries of recruitment

Northern Ireland
United Kingdom

Study participating centre

Room W2046

Coleraine
BT52 1SA
United Kingdom

Sponsor information

Department of Food, Agriculture and the Marine (Ireland)
Government

Agriculture House, Kildare St.
Dublin
Dublin 2
Ireland

Phone	+353 (0)1 607 2000
Email	info@agriculture.gov.ie
Website	http://www.nutramara.ie
"ROR"	https://ror.org/008gjgb19

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

19/05/2017: No publications found in PubMed, verifying study status with principal investigator.