Fish Oil and Cardiovascular Suboptimal Health

Phase 3

Completed

• Conditions: Suboptimal Health Status
• Interventions: Dietary Supplement: Omega -3 fatty acids

• Registration Number: NCT02103517
• Lead Sponsor: Chinese PLA General Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2014-03-27
• Study First Submitted QC: 2014-04-01
• Study First Posted: 2014-04-04
• Study Start: 2014-09
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-01
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 422

Inclusion Criteria

1. suboptimal health status, defined as the score of suboptimal health questionnaire ≥35.

2. at least one of cardiovascular risk factors:

   • overweight or obesity, defined as body mass index (BMI) ≥25 kg/m2.
   • systolic blood pressure ≥130 and <140 mmHg and diastolic blood pressure <90 mmHg, or diastolic blood pressure ≥85 and <90 mmHg and systolic blood pressure <140 mmHg
   • fasting plasma glucose ≥100 and <126 mg/dL
   • total cholesterol ≥200 and <240 mg/dL, triglyceride ≥150 and <200 mg/dL, low density lipoprotein-cholesterol ≥130 and <160 mg/dL,and/or high density lipoprotein-cholesterol <40 mg/dL

3. written informed consent

Exclusion Criteria

1. history of system diseases, such as cardiovascular diseases, digestive system diseases, diseases of respiratory system, blood and immune system diseases, nervous system diseases, endocrine system diseases, and diseases of the genitourinary system.
2. history of mental illness.
3. pregnant or breastfeeding.
4. use of antihypertensive, antidiabetic, or lipid-lowering drugs within the past two weeks.
5. use of fish oil capsules or other supplements containing omega-3 fatty acids within the past two weeks.
6. allergy or intolerance to fish oil, corn oil, omega-3 fatty acids, or vitamin E.
7. participation in another trial.
8. unable to promise to not use drugs and other fish oils during the study.
9. unable to provide informed written consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omega-3 fatty acid capsules	Omega -3 fatty acids	Omega-3 fatty acid capsules, 4 g/day, requiring intake 2 capsules (1g each one) in the morning and two at night for 3 months.

Primary Outcome Measures

Name	Time	Method
the improvement of suboptimal health status	three months	The improvement of suboptimal health status is evaluated by the change of the SHSQ-25 scores after intervention.
the improvement of traditional cardiovascular risk factors	three months	To investigate the changes of traditional cardiovascular risk factors such as blood pressure, lipids, fasting plasma glucose, and body mass index with three months supplementation of omega-3 fatty acids. Abnormal cardiovascular risk factors are defined according to the Adult Treatment Panel III criteria for metabolic syndromes and the recommendation by the Working Group on Obesity in China. The number of abnormal cardiovascular risk factors for each participant is recorded before and after intervention. If the number decreases after intervention, it means that the traditional cardiovascular risk factors have been improved.

Trial Locations

Locations (3)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China

First Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China

Sichuan Province People's Hospital; 🇨🇳 Chengdu, Sichuan, China