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 |
| Protocol serial number | N/A |
| Sponsor | King's College London (UK) |
| Funder | 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 |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Diabetes and Nutritional Science Division
4th Floor, Franklin-Wilkins Building
150 Stamford Street
London
SE1 9NH
United Kingdom
| Phone | +44 (0)20 7848 4273 |
|---|---|
| tom.sanders@kcl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single blind randomised crossover trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The 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 acronym | FICO |
| Study objectives | Meals 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) |
| Health condition(s) or problem(s) studied | Cardiovascular disease |
| Intervention | A 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 type | Other |
| Primary outcome measure(s) |
Blood 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. |
| Key secondary outcome measure(s) |
1. 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). |
| Completion date | 30/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target sample size at registration | 22 |
| Key inclusion criteria | Healthy men, aged 18 - 45 years |
| Key exclusion criteria | 1. 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 |
| Date of first enrolment | 28/01/2008 |
| Date of final enrolment | 30/07/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
SE1 9NH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/08/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
