NCT03111784

Brief Summary

IConsumption of fish provides a vital contribution to the survival and health of a significant portion of the world's population. Lipids in fish foods consist mainly of long-chain polyunsaturated fatty acids (PUFAs) such as eicosapentaenic acid (EPA, C20:5n-3) and docosahexaenoic acid (DHA C22:6n-3) which belongs to the physiologically important group of n-3 fatty acids. The increase of unsaturated fatty acids, along with the reduction of saturated fats, supports the lowering of blood cholesterol in humans and causes a positive impact on human nutrition. Polyunsaturated fatty acids (omega-3 fatty acids) plays a role in preventing heart disease and has anti-inflammatory and anti-thrombosis effects and these fatty acids cannot be synthesized and they must be obtained through diet. These nutritional benefits of fish consumption is mainly attributed to the effect of omega-3 polyunsaturated fatty acids , which are thought to have several potential cardio protective actions. This research is focused mainly identify highly consumed food fishes available in Batticaloa district( fresh, lagoon and sea water ) and their consumption pattern (cooking methods) of local community and by cardiovascular patients (CV) . Secondly Omega-3- Polyunsaturated fatty acid (PUFA) and tocopherol content (Vit E) in the fresh fish and dried or smoked fish of the highly consumed food fishes would be assessed and the relationship between fish consumption and its PUFA and Vit E content would be known. Also research will focus how lifestyle, socio-demographic factors' influences on the Cardiovascular diseases among community.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

8 months

First QC Date

April 8, 2017

Last Update Submit

April 12, 2017

Conditions

Keywords

Fish Consumption, Fatty acid composition, Lipid Profile, Tocopherol, Sociodemographics

Outcome Measures

Primary Outcomes (1)

  • Effect of fish consumption on Lipid Profiles

    Pre and Post interventional lipid profiles were compared with type of fish consumption.

    06 months

Interventions

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fish Consumers

You may not qualify if:

  • Vegetarians

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern University, Sri Lanka

Batticaloa, Eastern, 30350, Sri Lanka

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Quasi Experimental / non-randomised trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

April 8, 2017

First Posted

April 13, 2017

Study Start

December 1, 2015

Primary Completion

July 30, 2016

Study Completion

December 31, 2016

Last Updated

April 13, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations