Fish Oil and Cardiovascular Suboptimal Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

422 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-07-31

Brief Summary

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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.

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Detailed Description

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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

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Suboptimal Health Status

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Omega -3 fatty acids

Intervention Type DIETARY_SUPPLEMENT

Each subject assigned to active treatment group will receive 4 g/day capsule of omega-3 fatty acids.

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.

Group Type PLACEBO_COMPARATOR

Placebo: Corn oil

Intervention Type DIETARY_SUPPLEMENT

Each subject assigned to the control group will receive 4 g/day capsule of corn oil.

Interventions

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Omega -3 fatty acids

Each subject assigned to active treatment group will receive 4 g/day capsule of omega-3 fatty acids.

Intervention Type DIETARY_SUPPLEMENT

Placebo: Corn oil

Each subject assigned to the control group will receive 4 g/day capsule of corn oil.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes