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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hyperlipidemias
• Intervention / Treatment: Dietary supplement: Placebo oil; Dietary supplement: Echium oil; Dietary supplement: Mixed oil

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo oil; Ingredients: Corn oil, 500mg per capsule	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.
EXPERIMENTAL: Echium oil; Ingredients: Echium oil,500mg per capsule	Dietary supplement: 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.
EXPERIMENTAL: Mixed oil; Ingredients:Mixed oil(Echium oil,camelina oil,safflower oil) 500mg per capsule	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2018
• Primary Completion (ANTICIPATED): September 1, 2018
• Study Completion (ANTICIPATED): September 1, 2019

Study Registration Dates

• First Submitted: March 19, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (ACTUAL): April 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 9, 2018
• Last Update Submitted That Met QC Criteria: May 3, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Gut Microbiota; Metabolites; Hyperlipidemias; Polyunsaturated fatty acids; Echium oil
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
• Other Study ID Numbers: HPG2017102074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No