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| ID | Type | Description | Link |
|---|---|---|---|
| N3FACSH | Registry Identifier | n-3 Fatty Acids and Cardiovascular Suboptimal Health |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega-3 fatty acid capsules | Experimental | 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. |
|
| corn oil | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega -3 fatty acids | Dietary Supplement | Each subject assigned to active treatment group will receive 4 g/day capsule of omega-3 fatty acids. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
suboptimal health status, defined as the score of suboptimal health questionnaire ≥35.
at least one of cardiovascular risk factors:
written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qiang Zeng, M.D | Chinese PLA General Hospital | Principal Investigator |
| Sheng-Yong Dong, M.D | Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | 100853 | China | ||
| First Affiliated Hospital of Harbin Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29066159 | Derived | 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. |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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| Placebo: Corn oil | Dietary Supplement | Each subject assigned to the control group will receive 4 g/day capsule of corn oil. |
|
| Harbin |
| Heilongjiang |
| 150001 |
| China |
| Sichuan Province People's Hospital | Chengdu | Sichuan | 610000 | China |
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |