Clinical trial NCT03484988: The Effect of n-3 PUFA Plant Oil Intake on Human Metabolism
Official title: The Effect of n-3 PUFA Plant Oil Intake on Human Metabolism:A Randomized Double-Blind Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperlipidemias
Keywords: Polyunsaturated fatty acids
Echium oil
Hyperlipidemias
Metabolites
Gut Microbiota
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 150
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in blood lipids profile
timeFrame: At 0 week, 4th week, 12th week in intervention period
measure: Changes in vascular inflammation markers
timeFrame: At 0 week, 4th week, 12th week in intervention period
Secondary outcomes:
measure: Changes in plasma metabolites
timeFrame: At 0 week, 4th week, 12th week in intervention period
measure: Changes of microbiota metabolite in fecal
timeFrame: At 0 week, 4th week, 12th week in intervention period
measure: Changes in gut microbiota
timeFrame: At 0 week, 4th week, 12th week in intervention period
measure: single nucleotide polymorphism genotype
timeFrame: At 0 week
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Huazhong University of Science and Technology
state: Hubei
Study officials:
References: