Condition category
Circulatory System
Date applied
21/10/2010
Date assigned
27/10/2010
Last edited
30/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Tom Sanders

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

FICO

Study hypothesis

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

Bexley & Greenwich NHS Research Ethics Committee approved the study December 2007 (ref: 07/H0809/54)

Study design

Single blind randomised crossover trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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.

Secondary outcome measures

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).
2. A change in 8-isoprostane-F2alpha concentrations as an index of oxidative stress

Overall trial start date

28/01/2008

Overall trial end date

30/07/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy men, aged 18 - 45 years

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

22

Participant 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

Recruitment start date

28/01/2008

Recruitment end date

30/07/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Diabetes and Nutritional Science Division
London
SE1 9NH
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

Franklin-Wilkins Building
150 Stamford Street
London
SE1 9NH
United Kingdom
+44 (0)20 7848 4273
tom.sanders@kcl.ac.uk

Sponsor type

University/education

Website

http://www.kcl.ac.uk/index.aspx

Funders

Funder type

Research organisation

Funder name

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

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

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22348439

Publication citations

  1. Results

    Rontoyanni VG, Hall WL, Pombo-Rodrigues S, Appleton A, Chung R, Sanders TA, A comparison of the changes in cardiac output and systemic vascular resistance during exercise following high-fat meals containing DHA or EPA., Br. J. Nutr., 2012, 108, 3, 492-499, doi: 10.1017/S0007114511005721.

Additional files

Editorial Notes