The effects of high fat meals enriched with n-3 fatty acids on blood pressure at rest & during exercise

ISRCTN ISRCTN62232400
DOI https://doi.org/10.1186/ISRCTN62232400
Secondary identifying numbers N/A
Submission date
21/10/2010
Registration date
27/10/2010
Last edited
30/09/2013
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

Not provided at time of registration

Contact information

Prof Tom Sanders
Scientific

Diabetes and Nutritional Science Division
4th Floor, Franklin-Wilkins Building
150 Stamford Street
London
SE1 9NH
United Kingdom

+44 (0)20 7848 4273
tom.sanders@kcl.ac.uk

Study information

Study designSingle blind randomised crossover trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleThe acute effects of high fat meals enriched with eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA) versus oleic acid on cardiac output and other cardiovascular haemodynamics at rest and during dynamic exercise in healthy young men
Study acronymFICO
Study hypothesisMeals containing long-chain n-3 PUFA derived from fish oil, eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA), would cause a decrease in exercise systemic vascular resistance and attenuate the increase in exercise blood pressure
Ethics approval(s)Bexley & Greenwich NHS Research Ethics Committee approved the study December 2007 (ref: 07/H0809/54)
ConditionCardiovascular disease
InterventionA randomised, crossover intervention study to investigate the effects of high-fat meals (50g fat) containing high-oleic sunflower oil enriched with 5 g of either EPA or DHA, compared to a control high-fat meal (high-oleic sunflower oil only) on cardiovascular haemodynamics at rest and in response to exercise in 22 healthy males. Blood samples were taken and resting measurements of cardiac output, heart rate and BP were measured at baseline (before the meal) and then hourly over a 5-h period following the meal. A standardized 12 min exercise test was then conducted and further samples were taken and measurements made during exercise and post-exercise. There was at least a 1-week washout period between each of the 3 study days.
Intervention typeOther
Primary outcome measureBlood pressure (with heart rate and cardiac output), was measured at baseline (before the meal), and then 1, 2, 3 and 5 h after the meal, then at 3, 6 9 and 12 min during the 12-min multi-stage cycling protocol of moderate intensity. Then the subjects were allowed to recover from the exercise in a seated position and further measurements of blood pressure, heart rate and cardiac output were determined at 15, 30 and 45 min post-exercise.
Secondary outcome measures1. A change in arterial stiffness as measured by digital volume pulse (DVP) (stiffness index [SI] and reflection index [RI]) at baseline (before the meal), and then 1, 2, 3 and 5 h after the meal, and then 15, 30 and 45 min post-exercise (after the 12 min cycling protocol). Blood samples were taken for plasma isoprostanes analysis at baseline (before the meal), and then 5 h after the meal, and then immediately post-exercise (after the 12 min cycling protocol).
2. A change in 8-isoprostane-F2alpha concentrations as an index of oxidative stress
Overall study start date28/01/2008
Overall study end date30/07/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexMale
Target number of participants22
Participant inclusion criteriaHealthy men, aged 18 - 45 years
Participant exclusion criteria1. Current smokers or those smoked in the past 6 months
2. Consumption of more than a portion of oily fish per week and/or regular fish oil supplementation within the past 3 months
3. Body mass index less than 18.0 and greater than 30 kg/m2
4. Seated blood pressure of or greater than 140/90mmHg
5. Plasma total cholesterol > 7.8 mmol/L;
6. Plasma triacylglycerol (TAG) >3.0 mmol/L;
7.Diabetes mellitus (fasting plasma glucose >7.0 mmol/L)
8. Abnormal haematology or liver function tests
9. Self-reported history of myocardial infarction, angina, venous thrombosis, stroke, cancer
10. Presence of gastrointestinal disorder or use of a drug, which is likely to alter gastrointestinal motility or nutrient absorption
11. Self-reported weekly alcohol intake of > 28 standard units of alcohol (1 unit = 10 mL ethanol)
12. Systematic use of any kind of drug or prescribed blood pressure anti-inflammatory or blood-thinning medication
Recruitment start date28/01/2008
Recruitment end date30/07/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Diabetes and Nutritional Science Division
London
SE1 9NH
United Kingdom

Sponsor information

King's College London (UK)
University/education

Franklin-Wilkins Building
150 Stamford Street
London
SE1 9NH
England
United Kingdom

+44 (0)20 7848 4273
tom.sanders@kcl.ac.uk
http://www.kcl.ac.uk/index.aspx
ROR logo https://ror.org/0220mzb33

Funders

Funder type

Research organisation

Guy's & St Thomas' NHS Foundation Trust in partnership with King's College London (UK) - State Scholarships Foundation (I.K.Y.) & the Department of Health via the National Institute for Health Research (NIHR) comprehensive Biomedical Research Centre award

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2012 Yes No
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