Fish Oil and Cardiovascular Suboptimal Health

January 1, 2017 updated by: Qiang Zeng, MD, Chinese PLA General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

422

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Chinese PLA General Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • First Affiliated Hospital of Harbin Medical University
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Sichuan Province People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Omega-3 fatty acid capsules
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.
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 Comparator: corn oil
Corn oil in similar presentation as omega-3 fatty acid capsules, requiring intake 2 capsules in the morning and two at night for 3 months.
Dietary supplement: Placebo: Corn oil
Each subject assigned to the control group will receive 4 g/day capsule of corn oil.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the improvement of suboptimal health status
Time Frame: three months
The improvement of suboptimal health status is evaluated by the change of the SHSQ-25 scores after intervention.
three months
the improvement of traditional cardiovascular risk factors
Time Frame: 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.
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Investigators

  • Principal Investigator: Qiang Zeng, M.D, Chinese PLA General Hospital
  • Principal Investigator: Sheng-Yong Dong, M.D, Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

March 27, 2014

First Submitted That Met QC Criteria

April 1, 2014

First Posted (Estimate)

April 4, 2014

Study Record Updates

Last Update Posted (Estimate)

January 4, 2017

Last Update Submitted That Met QC Criteria

January 1, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2012BAI37B04
  • N3FACSH (Registry Identifier: n-3 Fatty Acids and Cardiovascular Suboptimal Health)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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