The Effect of n-3 PUFA Plant Oil Intake on Human Metabolism

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of n-3 PUFA Plant Oil Intake on Human Metabolism:A Randomized Double-Blind Trial

Conditions
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Hyperlipidemias

Intervention / Treatment
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* Dietary Supplement: Placebo oil
* Dietary Supplement: Echium oil
* Dietary Supplement: Mixed oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 30-60 years of age Marginal elevated blood lipids or hyperlipidemia[Total cholesterol≥5.2 mmol/L(200 mg/dl) or triglyceride≥1.70 mmol/L(150mg/dl) or low density lipoprotein cholesterol≥3.4 mmol/L(130 mg/dl)] Exclusion Criteria: Pregnancy； Known cardiovascular disease, diabetes, hypertension and any other chronic disease； Known gastrointestinal disease, such as Irritable Bowel Syndrome(IBS), functional bowel disease and so on； Acute or chronic inflammatory conditions; Liver or kidney dysfunction; An unwillingness to discontinue nutritional supplements； Use of lipid-lowering, antiinflammatory, antidepressant, or blood pressure medication; Evidence of drug or alcohol abuse； Take antibiotics or probiotics in the last three months.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo oil<br>Ingredients: Corn oil, 500mg per capsule | Dietary Supplement: Placebo oil<br>* 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.<br>|
| Experimental: Echium oil<br>Ingredients: Echium oil,500mg per capsule | Dietary Supplement: Echium oil<br>* 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.<br>|
| Experimental: Mixed oil<br>Ingredients:Mixed oil(Echium oil,camelina oil,safflower oil) 500mg per capsule | Dietary Supplement: Mixed oil<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polyunsaturated fatty acids, Echium oil, Hyperlipidemias, Metabolites, Gut Microbiota