Back to resultsThe Effect of n-3 PUFA Plant Oil Intake on Human Metabolism (PUFA)
Primary Purpose
Hyperlipidemias
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Placebo oil
Echium oil
Mixed oil
Sponsored by
About this trial
This is an interventional prevention trial for Hyperlipidemias focused on measuring Polyunsaturated fatty acids, Echium oil, Hyperlipidemias, Metabolites, Gut Microbiota
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.
Sites / Locations
- Huazhong University of Science and Technology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo oil
Echium oil
Mixed oil
Arm Description
Ingredients: Corn oil, 500mg per capsule
Ingredients: Echium oil,500mg per capsule
Ingredients:Mixed oil(Echium oil,camelina oil,safflower oil) 500mg per capsule
Outcomes
Primary Outcome Measures
Changes in blood lipids profile
Fasting serum total cholesterol, low density lipoprotein, high density lipoprotein and triglycerides
Changes in vascular inflammation markers
Fasting plasma C-reactive protein, soluble intercellular adhesion molecule-1, soluble vascular cell adhesion molecule-1, soluble E-selectin
Secondary Outcome Measures
Changes in plasma metabolites
Plasma phospholipid fatty acid profile
Changes of microbiota metabolite in fecal
short chain fatty acids (SCFA)
Changes in gut microbiota
next generation sequencing
single nucleotide polymorphism genotype
time of flight mass spectrometry
Full Information
NCT ID
NCT03484988
First Posted
March 19, 2018
Last Updated
May 3, 2018
Sponsor
Huazhong University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT03484988
Brief Title
The Effect of n-3 PUFA Plant Oil Intake on Human Metabolism
Acronym
PUFA
Official Title
The Effect of n-3 PUFA Plant Oil Intake on Human Metabolism:A Randomized Double-Blind Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2018 (Anticipated)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemias
Keywords
Polyunsaturated fatty acids, Echium oil, Hyperlipidemias, Metabolites, Gut Microbiota
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
The all details of groups assignment are arranged and controlled by the research designers. The color, shape, and external packaging of the n-3 polyunsaturated fatty acid and placebo are consistent (faint yellow to yellow oil in transparent soft capsules). Each bottle of capsules will be marked with the name (or identify number) of the participants by research designers. Thus, the grouping of participants is blind to the rest of the researchers (like outcomes assessors).
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo oil
Arm Type
Placebo Comparator
Arm Description
Ingredients: Corn oil, 500mg per capsule
Arm Title
Echium oil
Arm Type
Experimental
Arm Description
Ingredients: Echium oil,500mg per capsule
Arm Title
Mixed oil
Arm Type
Experimental
Arm Description
Ingredients:Mixed oil(Echium oil,camelina oil,safflower oil) 500mg per capsule
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo oil
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Echium oil
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Mixed oil
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in blood lipids profile
Description
Fasting serum total cholesterol, low density lipoprotein, high density lipoprotein and triglycerides
Time Frame
At 0 week, 4th week, 12th week in intervention period
Title
Changes in vascular inflammation markers
Description
Fasting plasma C-reactive protein, soluble intercellular adhesion molecule-1, soluble vascular cell adhesion molecule-1, soluble E-selectin
Time Frame
At 0 week, 4th week, 12th week in intervention period
Secondary Outcome Measure Information:
Title
Changes in plasma metabolites
Description
Plasma phospholipid fatty acid profile
Time Frame
At 0 week, 4th week, 12th week in intervention period
Title
Changes of microbiota metabolite in fecal
Description
short chain fatty acids (SCFA)
Time Frame
At 0 week, 4th week, 12th week in intervention period
Title
Changes in gut microbiota
Description
next generation sequencing
Time Frame
At 0 week, 4th week, 12th week in intervention period
Title
single nucleotide polymorphism genotype
Description
time of flight mass spectrometry
Time Frame
At 0 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liegang Liu, MD，PhD
Phone
+86-27-83650522
Email
liegangliu@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jiawei Yin
Email
M201575208@hust.edu.cn
Facility Information:
Facility Name
Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Effect of n-3 PUFA Plant Oil Intake on Human Metabolism
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