Fish Oil and Cardiovascular Suboptimal Health
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
2 other identifiers
interventional
422
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2014
Shorter than P25 for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2014
CompletedFirst Posted
Study publicly available on registry
April 4, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedJanuary 4, 2017
January 1, 2017
10 months
March 27, 2014
January 1, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (2)
Omega-3 fatty acid capsules
EXPERIMENTALOmega-3 fatty acid capsules, 4 g/day, requiring intake 2 capsules (1g each one) in the morning and two at night for 3 months.
corn oil
PLACEBO COMPARATORCorn oil in similar presentation as omega-3 fatty acid capsules, requiring intake 2 capsules in the morning and two at night for 3 months.
Interventions
Each subject assigned to active treatment group will receive 4 g/day capsule of omega-3 fatty acids.
Each subject assigned to the control group will receive 4 g/day capsule of corn oil.
Eligibility Criteria
You may qualify if:
- suboptimal health status, defined as the score of suboptimal health questionnaire ≥35.
- 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
- written informed consent
You may not qualify if:
- 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.
- history of mental illness.
- pregnant or breastfeeding.
- use of antihypertensive, antidiabetic, or lipid-lowering drugs within the past two weeks.
- use of fish oil capsules or other supplements containing omega-3 fatty acids within the past two weeks.
- allergy or intolerance to fish oil, corn oil, omega-3 fatty acids, or vitamin E.
- participation in another trial.
- unable to promise to not use drugs and other fish oils during the study.
- unable to provide informed written consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
Sichuan Province People's Hospital
Chengdu, Sichuan, 610000, China
Related Publications (1)
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.
PMID: 29066159DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qiang Zeng, M.D
Chinese PLA General Hospital
- PRINCIPAL INVESTIGATOR
Sheng-Yong Dong, M.D
Chinese PLA General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 27, 2014
First Posted
April 4, 2014
Study Start
September 1, 2014
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
January 4, 2017
Record last verified: 2017-01