The Effect of n-3 PUFA Plant Oil Intake on Human Metabolism
PUFA
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2018
CompletedFirst Posted
Study publicly available on registry
April 2, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedMay 9, 2018
May 1, 2018
3 months
March 19, 2018
May 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Changes in plasma metabolites
At 0 week, 4th week, 12th week in intervention period
Changes of microbiota metabolite in fecal
At 0 week, 4th week, 12th week in intervention period
Changes in gut microbiota
At 0 week, 4th week, 12th week in intervention period
single nucleotide polymorphism genotype
At 0 week
Study Arms (3)
Placebo oil
PLACEBO COMPARATORIngredients: Corn oil, 500mg per capsule
Echium oil
EXPERIMENTALIngredients: Echium oil,500mg per capsule
Mixed oil
EXPERIMENTALIngredients:Mixed oil(Echium oil,camelina oil,safflower oil) 500mg per capsule
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Aged between 30-60 years of age
- Marginal elevated blood lipids or hyperlipidemia\[Total cholesterol≥5.2 mmol/L(200 mg/dl) or triglyceride≥1.70 mmol/L(150mg/dl) or low density lipoprotein cholesterol≥3.4 mmol/L(130 mg/dl)\]
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- 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).
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 19, 2018
First Posted
April 2, 2018
Study Start
June 1, 2018
Primary Completion
September 1, 2018
Study Completion
September 1, 2019
Last Updated
May 9, 2018
Record last verified: 2018-05