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

Hyperlipidemias Clinical Trial

— PUFA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03484988
• Other study ID #: HPG2017102074
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2018
• Est. completion date: September 2019

Study information

• Verified date: May 2018
• Source: Huazhong University of Science and Technology
• Contact: Liegang Liu, MD,PhD
• Phone: +86-27-83650522
• Email: liegangliu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: September 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Dietary Supplement:
• Placebo 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.
• Echium 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.
• Mixed 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.

Locations

Country	Name	City	State
China	Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Changes in plasma metabolites	Plasma phospholipid fatty acid profile	At 0 week, 4th week, 12th week in intervention period
Secondary	Changes of microbiota metabolite in fecal	short chain fatty acids (SCFA)	At 0 week, 4th week, 12th week in intervention period
Secondary	Changes in gut microbiota	next generation sequencing	At 0 week, 4th week, 12th week in intervention period
Secondary	single nucleotide polymorphism genotype	time of flight mass spectrometry	At 0 week