Hyperlipidemias
Conditions
Keywords
Polyunsaturated fatty acids, Echium oil, Hyperlipidemias, Metabolites, Gut Microbiota
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTPlacebo oil
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.
DIETARY_SUPPLEMENTEchium oil
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.
DIETARY_SUPPLEMENTMixed oil
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.
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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).
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in blood lipids profile | At 0 week, 4th week, 12th week in intervention period | Fasting serum total cholesterol, low density lipoprotein, high density lipoprotein and triglycerides |
| Changes in vascular inflammation markers | At 0 week, 4th week, 12th week in intervention period | Fasting plasma C-reactive protein, soluble intercellular adhesion molecule-1, soluble vascular cell adhesion molecule-1, soluble E-selectin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in plasma metabolites | At 0 week, 4th week, 12th week in intervention period | Plasma phospholipid fatty acid profile |
| Changes of microbiota metabolite in fecal | At 0 week, 4th week, 12th week in intervention period | short chain fatty acids (SCFA) |
| Changes in gut microbiota | At 0 week, 4th week, 12th week in intervention period | next generation sequencing |
| single nucleotide polymorphism genotype | At 0 week | time of flight mass spectrometry |
Countries
China
Contacts
Primary ContactLiegang Liu, MD，PhD
Backup ContactJiawei Yin
Outcome results
None listed