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

Not Applicable

• Conditions: Hyperlipidemias
• Interventions: Dietary Supplement: Mixed oil; Dietary Supplement: Placebo oil; Dietary Supplement: Echium oil

• Registration Number: NCT03484988
• Lead Sponsor: Huazhong University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-19
• Study First Submitted QC: 2018-03-26
• Study First Posted: 2018-04-02
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-03
• Last Update Posted: 2018-05-09
• Study Start: 2018-06
• Primary Completion: 2018-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mixed oil	Mixed oil	Ingredients:Mixed oil(Echium oil,camelina oil,safflower oil) 500mg per capsule
Placebo oil	Placebo oil	Ingredients: Corn oil, 500mg per capsule
Echium oil	Echium oil	Ingredients: Echium oil,500mg per capsule

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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
Changes of microbiota metabolite in fecal	At 0 week, 4th week, 12th week in intervention period	short chain fatty acids (SCFA)
Changes in plasma metabolites	At 0 week, 4th week, 12th week in intervention period	Plasma phospholipid fatty acid profile

Trial Locations

Locations (1)

Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China