Effects of fish consumption on cardiovascular risk factors
| ISRCTN | ISRCTN12896693 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12896693 |
| ClinicalTrials.gov number | NCT03111784 |
| Secondary identifying numbers | N/A |
- Submission date
- 08/05/2017
- Registration date
- 09/05/2017
- Last edited
- 29/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Consuming fish is a good source of omega-3 fatty acids. Omega-3 fatty acids are good for the heart and can help those who are at high risk of cardiovascular disease (CVD). Fish plays an important role in many diets. The atherogenic index is a tool to identify people with CVD risk. Lipids (fats in the drugs) are usually lowered by a diet rich in fish which can decrease the risk of heart diseases. However, there are many lifestyle and social/economic backgrounds that can impact CVD risk. The aim of this study is to evaluate the lipid profile in healthy people with different fish consumption habits to assess their CVD risk level.
Who can participate?
Healthy adults aged 23 to 30 years old.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group eat curried fish (containing coconut cream) daily (300g weekly) for six months. Those in the second group are fed daily with fish fried in coconut oil (300 grams per week) for six months. Participants are assessed before and after the study to assess their lipids levels, body mass index, and blood pressure.
What are the possible benefits and risks of participating?
There are no notable benefits or risks with participating.
Where is the study run from?
Eastern University, Sri Lanka (Sri Lanka)
When is the study starting and how long is it expected to run for?
August 2015 to April 2016
Who is funding the study?
Eastern University, Sri Lanka (Sri Lanka)
Who is the main contact?
Mrs Chandravathany Devadawson
Contact information
Scientific
Department of Zoology
Eastern University, Sri Lanka
Chenkalady
Battcialao
30350
Sri Lanka
 ORCID ID |
0000-0002-0557-6274 |
|---|
Study information
| Study design | Interventional randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effects of fish consumption on cardiovascular risk factors: a quasi-experimental study |
| Study objectives | The aim of this study is understand the relationship of fish consumption and its pattern in cardiovascular disease (CVD) from the Eastern Sri Lankan community. |
| Ethics approval(s) | Ethical Committee Faculty Of Health Care Sciences Eastern University, Sri Lanka, 21/10/2014, ref: EUSL/FHCS/ERC/2014/27 |
| Health condition(s) or problem(s) studied | Cardiovascular diseases |
| Intervention | Participants undergo a baseline examination for lipid profiles, body mass index (BMI), blood pressure (BP). Participants take a pre-tested questionnaire used to collect data on dietary habits including fish consumption and other socio-demogrpahic characteristics. Participants are randomly allocated to one of two groups. Group 1: Participants are fed daily with fish prepared as a curry containing coconut cream (300 grams per week for six months). Group 2: Participants are fed daily with fish fried in coconut oil (300 grams per week for six months). Fasting blood samples are collected from healthy people for lipid profile estimations with an automated analyzer after the intervention. Detailed information regarding physical and atherogenic parameters was collected from each participant. Participant’s lipid profiles, body mass index (BMI) , blood pressure (BP) are measured at the end of the six months. |
| Intervention type | Other |
| Primary outcome measure | 1. Type of fish consumption is measured using participant records at six months 2. Amount of fish consumption is measured using participant records gram at six months 3. Time of consumption is measured using the participant records at six months 4. Processing type of fish is measured using the participant record at six months 5. Sociodemographics are measured using the pretested semi –structured questionnaire at baseline |
| Secondary outcome measures | Cardiovascular risk profiles are measured using blood samples and biochemistry lab automatic analysis at baseline and six months. |
| Overall study start date | 01/08/2015 |
| Completion date | 30/04/2016 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 599 |
| Key inclusion criteria | Healthy adults aged 23 to 30 years old. |
| Key exclusion criteria | People who do not eat fish |
| Date of first enrolment | 31/08/2015 |
| Date of final enrolment | 01/09/2015 |
Locations
Countries of recruitment
- Sri Lanka
Study participating centre
Chenkalady
Batticaloa
30350
Sri Lanka
Sponsor information
University/education
Vanthrumoolai
Chenkalady
Battcaloa
30350
Sri Lanka
| Website | www.esn.ac.lk |
|---|---|
"ROR" |
https://ror.org/01jrs3715 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/10/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Mrs Chandravathany Devadawson chand_oo@yahoo.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 29/01/2019 | Yes | No |
Editorial Notes
29/01/2019: Publication reference added
