Fish Oil and Cardiovascular Suboptimal Health

Suboptimal Health Status Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02103517
• Other study ID #: 2012BAI37B04
• Secondary ID: N3FACSH
• Status: Completed
• Phase: Phase 3
• First received: March 27, 2014
• Last updated: January 1, 2017
• Start date: September 2014
• Est. completion date: July 2015

Study information

• Verified date: January 2017
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 422
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Suboptimal Health Status

Intervention

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

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing
China	Sichuan Province People's Hospital	Chengdu	Sichuan
China	First Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the improvement of suboptimal health status	The improvement of suboptimal health status is evaluated by the change of the SHSQ-25 scores after intervention.	three months	No
Primary	the improvement of traditional cardiovascular risk factors	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.	three months	No