Condition category
Circulatory System
Date applied
08/05/2017
Date assigned
09/05/2017
Last edited
09/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

www.esn.ac.lk

Contact information

Type

Scientific

Primary contact

Mrs Chandravathany Devadawson

ORCID ID

http://orcid.org/0000-0002-0557-6274

Contact details

Department of Zoology
Eastern University
Sri Lanka
Chenkalady
Battcialao
30350
Sri Lanka

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT03111784

Protocol/serial number

N/A

Study information

Scientific title

Effects of fish consumption on cardiovascular risk factors: a quasi-experimental study

Acronym

Study hypothesis

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

Ethical Committee Faculty Of Health Care Sciences Eastern University, Sri Lanka, 21/10/2014, ref: EUSL/FHCS/ERC/2014/27

Study design

Interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Screening

Patient information sheet

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

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/08/2015

Overall trial end date

30/04/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy adults aged 23 to 30 years old.

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

599

Participant exclusion criteria

People who do not eat fish

Recruitment start date

31/08/2015

Recruitment end date

01/09/2015

Locations

Countries of recruitment

Sri Lanka

Trial participating centre

Department of Zoology
Eastern University, Sri Lanka Chenkalady
Batticaloa
30350
Sri Lanka

Sponsor information

Organisation

Eastern University, Sri Lanka

Sponsor details

Vanthrumoolai
Chenkalady
Battcaloa
30350
Sri Lanka

Sponsor type

University/education

Website

www.esn.ac.lk

Funders

Funder type

University/education

Funder name

University Grant Commission Sri Lanka

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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

Intention to publish date

01/10/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes