Clinical trial NCT02103517: Fish Oil and Cardiovascular Suboptimal Health
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Suboptimal Health Status
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2014-04-04
Enrollment: 422
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the improvement of suboptimal health status
timeFrame: three months
measure: the improvement of traditional cardiovascular risk factors
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Harbin
country: China
facility: First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Chengdu
country: China
facility: Sichuan Province People's Hospital
state: Sichuan
Study officials:
affiliation: Chinese PLA General Hospital
name: Qiang Zeng, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese PLA General Hospital
name: Sheng-Yong Dong, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zeng Q, Dong SY, Liu YP, Fu J, Shuai P, Zhao ZM, Li TX. Effects of fish oil-derived fatty acids on suboptimal cardiovascular health: A multicenter, randomized, double-blind, placebo-controlled trial. Nutr Metab Cardiovasc Dis. 2017 Nov;27(11):964-970. doi: 10.1016/j.numecd.2017.09.004. Epub 2017 Sep 21.