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

Huazhong University of Science and Technology

Status: Unknown

Conditions: Hyperlipidemias

Treatments: Dietary Supplement: Placebo oil; Dietary Supplement: Mixed oil; Dietary Supplement: Echium oil

Study type: Interventional

Funder types: Other

Identifiers

NCT03484988

HPG2017102074

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups, including a placebo group

Placebo oil

Placebo Comparator group

Description:

Ingredients: Corn oil, 500mg per capsule

Treatment:

Dietary Supplement: Placebo oil

Echium oil

Experimental group

Description:

Ingredients: Echium oil,500mg per capsule

Treatment:

Dietary Supplement: Echium oil

Mixed oil

Experimental group

Description:

Ingredients:Mixed oil(Echium oil,camelina oil,safflower oil) 500mg per capsule

Treatment:

Dietary Supplement: Mixed oil