Fish Oil and Cardiovascular Suboptimal Health

Chinese PLA General Hospital (301 Hospital)

Status and phase: Completed; Phase 3

Conditions: Suboptimal Health Status

Treatments: Dietary Supplement: Omega -3 fatty acids; Dietary Supplement: Placebo: Corn oil

Study type: Interventional

Funder types: Other

Identifiers

NCT02103517

2012BAI37B04

N3FACSH (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 422 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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422 participants in 2 patient groups, including a placebo group

Omega-3 fatty acid capsules

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Omega -3 fatty acids

corn oil

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo: Corn oil