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The findings of previous experiments suggested that polyunsaturated fatty acids(PUFAs) has been linked to anti-hyperlipidemia, and reducing the risk of cardiovascular disease.This is a randomized double-blind trial, aims to study the effect of PUFAs on blood lipids and human metabolism. Firstly, the investigators will investigate the efficacy of mixed plant oil(echium oil, camelina oil, safflower oil) and pure echium oil on improving the levels of blood lipids. Secondly, next generation sequencing (NGS), ultra-high performance liquid chromatography-tandem mass spectrometric (UPLC-MS/MS) and gas chromatography-mass spectrometry detection will be conducted to explore the role of PUFAs on gut microbiota as well as metabolites. Thirdly, single nucleotide polymorphism will be genotyped by Time-of-flight mass spectrometry to find the gene-environment interaction effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo oil | Placebo Comparator | Ingredients: Corn oil, 500mg per capsule |
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| Echium oil | Experimental | Ingredients: Echium oil,500mg per capsule |
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| Mixed oil | Experimental | Ingredients:Mixed oil(Echium oil,camelina oil,safflower oil) 500mg per capsule |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo oil | Dietary Supplement | The participants were asked to take corn oil capsule twice a day, 4 capsules (500mg/capsules) each time. The intervention period is about 3 months. Do not take any other medicine, traditional Chinese medicine, or dietary supplements. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in blood lipids profile | Fasting serum total cholesterol, low density lipoprotein, high density lipoprotein and triglycerides | At 0 week, 4th week, 12th week in intervention period |
| Changes in vascular inflammation markers | Fasting plasma C-reactive protein, soluble intercellular adhesion molecule-1, soluble vascular cell adhesion molecule-1, soluble E-selectin | At 0 week, 4th week, 12th week in intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in plasma metabolites | Plasma phospholipid fatty acid profile | At 0 week, 4th week, 12th week in intervention period |
| Changes of microbiota metabolite in fecal | short chain fatty acids (SCFA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liegang Liu, MD,PhD | Contact | +86-27-83650522 | liegangliu@gmail.com | |
| Jiawei Yin | Contact | M201575208@hust.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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The all details of groups assignment are arranged and controlled by the research designers. The color, shape, and external packaging of the n-3 polyunsaturated fatty acid and placebo are consistent (faint yellow to yellow oil in transparent soft capsules). Each bottle of capsules will be marked with the name (or identify number) of the participants by research designers. Thus, the grouping of participants is blind to the rest of the researchers (like outcomes assessors).
| Echium oil | Dietary Supplement | The participants were asked to take echium oil capsule twice a day, 4 capsules (500mg/capsules) each time. The intervention period is about 3 months. Do not take any other medicine, traditional Chinese medicine, or dietary supplements. |
|
| Mixed oil | Dietary Supplement | The participants were asked to take mixed oil(echium oil,camelina oil,safflower oil) twice a day, 4 capsules (500mg/capsules) each time. The intervention period is about 3 months. Do not take any other medicine, traditional Chinese medicine, or dietary supplements. |
|
| At 0 week, 4th week, 12th week in intervention period |
| Changes in gut microbiota | next generation sequencing | At 0 week, 4th week, 12th week in intervention period |
| single nucleotide polymorphism genotype | time of flight mass spectrometry | At 0 week |