The Influence of n-3 Fatty acid Supplementation on Vascular and Cognitive Function in Healthy Young Adults; a Randomized Controlled Trial
ISRCTN | ISRCTN19987575 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN19987575 |
Secondary identifying numbers | N3RCT07 |
- Submission date
- 27/01/2005
- Registration date
- 05/05/2005
- Last edited
- 03/07/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Atul Singhal
Scientific
Scientific
Institute of Child Health
London
WC1N 1EH
United Kingdom
Phone | +44 (0)2079052389 |
---|---|
a.singhal@ich.ucl.ac.uk |
Study information
Study design | Randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | |
Study acronym | N3RCT |
Study objectives | 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(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Cardiovascular disease |
Intervention | Docosahexaenoic acid v Placebo |
Intervention type | Other |
Primary outcome measure | 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 study start date | 01/11/2004 |
Completion date | 31/05/2006 |
Eligibility
Participant type(s) | Healthy volunteer |
---|---|
Age group | Adult |
Sex | Not Specified |
Target number of participants | 300 |
Key inclusion criteria | Healthy volunteers |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/11/2004 |
Date of final enrolment | 31/05/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Institute of Child Health
London
WC1N 1EH
United Kingdom
WC1N 1EH
United Kingdom
Sponsor information
Institute of Child Health (UK)
Government
Government
30 Guilford Street
London
WC1N 1EH
United Kingdom
Phone | +44 (0)20 7242 9789 |
---|---|
t.austin@ich.ucl.ac.uk | |
Website | http://www.ucl.ac.uk/ich/homepage |
https://ror.org/02jx3x895 |
Funders
Funder type
Not defined
Part of MRC Programme Grant
No information available
Kellogg's Sales & Marketing plc
No information available
Martek Biosciences plc
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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | Results | 01/07/2013 | Yes | No |