Contact information
Type
Scientific
Primary contact
Dr Atul Singhal
ORCID ID
Contact details
Institute of Child Health
London
WC1N 1EH
United Kingdom
+44 (0)2079052389
a.singhal@ich.ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N3RCT07
Study information
Scientific title
Acronym
N3RCT
Study hypothesis
Primary:
Cardiovascular:
n-3 PUFA supplementation improves vascular function (flow-mediated endothelial dependent dilation) in healthy young adults.
Cognitive:
n-3 PUFA supplementation improves cognitive function in healthy young adults.
Secondary:
Cardiovascular:
n-3 PUFA supplementation improves other cardiovascular risk-factors in healthy young adults (vascular, biochemical and haematological).
Cognitive:
n-3 PUFA supplementation improves mood in healthy young adults.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Cardiovascular disease
Intervention
Docosahexaenoic acid v Placebo
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Cardiovascular:
Flow mediated endothelial dependent dilatation of the brachial artery, arterial distensibility and pulse wave velocity.
Cognitive:
CANTAB (CAmbridge Neuropsychological Test Automated Battery).
Secondary outcome measures
Cardiovascular:
Plasma and red cell DHA and EPA levels and biochemical and haematolgical risk factors for CVD including such as fasting insulin, glucose, 32-33 split proinsulin, and leptin concentration and lipid profile including lipoprotein particle size will be determined. Hematological risk factors for CVD will include FBC, fibrinogen, factors VII and VIII, von Willebrand factor, soluble thrombomodulin and tissue plasminogen activator concentrations and inflammatory markers such as IL-6, IL-8 and CRP. Evidence of endothelial cell activation will be sought by the measurement of intra cellular adhesion molecule¿1 (ICAM-1), vascular cell adhesion molecule¿1 (VCAM-1), E-selectin, P-selectin IL-6 and other cell adhesion factors.
Cognitive:
Wechsler Abbreviated Scale of Intelligence (WASI; 29); inspection time, and a self-administered measure of mood (5 minutes) using visual analogue scales.
Overall trial start date
01/11/2004
Overall trial end date
31/05/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Healthy volunteers
Participant type
Healthy volunteer
Age group
Adult
Gender
Not Specified
Target number of participants
300
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/11/2004
Recruitment end date
31/05/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Child Health
London
WC1N 1EH
United Kingdom
Sponsor information
Organisation
Institute of Child Health (UK)
Sponsor details
30 Guilford Street
London
WC1N 1EH
United Kingdom
+44 (0)20 7242 9789
t.austin@ich.ucl.ac.uk
Sponsor type
Government
Website
Funders
Funder type
Not defined
Funder name
Part of MRC Programme Grant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Kellogg's Sales & Marketing plc
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Martek Biosciences plc
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
1. Results in http://www.ncbi.nlm.nih.gov/pubmed/23817470
Publication citations
-
Results
Singhal A, Lanigan J, Storry C, Low S, Birbara T, Lucas A, Deanfield J, Docosahexaenoic acid supplementation, vascular function and risk factors for cardiovascular disease: a randomized controlled trial in young adults., J Am Heart Assoc, 2013, 2, 4, e000283, doi: 10.1161/JAHA.113.000283.