NCT02103517

Fish Oil and Cardiovascular Suboptimal Health

Risk and Prevention Study: Optimisation of the Preventive Strategies and Evaluation of the Efficacy of n-3 Fatty Acids in Subjects at High Cardiovascular Risk and Suboptimal Health Status

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 422 (actual)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether omega-3 fatty acids supplementation are effective in the improvement of suboptimal health status and cardiovascular risk.

Detailed description

The Suboptimal health status questionnaire (SHSQ-25) is used to evaluate the suboptimal health status. The SHSQ-25 includes 25 questions. The score of the SHSQ-25 is from 0 to 100. Suboptimal health status is defined as the SHSQ-25 score above than 35. The higher scores of the SHSQ-25 one gets, the more severity of suboptimal health status he/she has. All participants are asked to fill in the SHSQ-25 before and after the intervention. If the score decreases after the intervention, it means that the suboptimal health status has been improved.

Conditions

• Suboptimal Health Status

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Omega -3 fatty acids	Each subject assigned to active treatment group will receive 4 g/day capsule of omega-3 fatty acids.
DIETARY_SUPPLEMENT	Placebo: Corn oil	Each subject assigned to the control group will receive 4 g/day capsule of corn oil.

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2014-04-04
• Last updated: 2017-01-04

Locations

3 sites across 1 country: China