HyperlipidemiasPUFANCT03484988
The Effect of n-3 PUFA Plant Oil Intake on Human Metabolism
A study testing Echium oil and Mixed oil in people with Hyperlipidemias, run by Huazhong University of Science and Technology at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Hyperlipidemias
- What is being tested?
- Echium oil and Mixed oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Jun 2018to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)]
Who cannot join
- 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；
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- 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 locations and contacts
1 site in 1 country.
Jiawei Yin contact
About this study
Official title: 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.
- Conditions
- Hyperlipidemias
- Being tested
- Placebo oil, Echium oil, Mixed oil
- Keywords
- Polyunsaturated fatty acids, Echium oil, Hyperlipidemias, Metabolites, Gut Microbiota
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo oilDietary supplement
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 oilDietary supplement
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 oilDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo oil | Placebo comparator | Ingredients: Corn oil, 500mg per capsule Receives: Dietary Supplement: Placebo oil |
| Echium oil | Experimental | Ingredients: Echium oil,500mg per capsule Receives: Dietary Supplement: Echium oil |
| Mixed oil | Experimental | Ingredients:Mixed oil(Echium oil,camelina oil,safflower oil) 500mg per capsule Receives: Dietary Supplement: Mixed oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood lipids profile
Fasting serum total cholesterol, low density lipoprotein, high density lipoprotein and triglycerides
Measured: 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
Measured: At 0 week, 4th week, 12th week in intervention period
Secondary outcomes (4)
Changes in plasma metabolites
Plasma phospholipid fatty acid profile
Measured: At 0 week, 4th week, 12th week in intervention period
Changes of microbiota metabolite in fecal
short chain fatty acids (SCFA)
Measured: At 0 week, 4th week, 12th week in intervention period
Changes in gut microbiota
next generation sequencing
Measured: At 0 week, 4th week, 12th week in intervention period
single nucleotide polymorphism genotype
time of flight mass spectrometry
Measured: At 0 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study startJun 2018 (estimated)
- Primary completionSep 2018 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liegang Liu, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484988
- Sponsor's protocol ID
- HPG2017102074
- Acronym
- PUFA
- Status last verified
- May 2018
- First submitted
- 19 Mar 2018
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of n-3 PUFA Plant Oil Intake on Human Metabolism:A Randomized Double-Blind Trial
- ClinicalTrials.gov ID
- NCT03484988
- Acronym / sponsor ID
- PUFA / HPG2017102074
- Conditions
- Hyperlipidemias
- Keywords
- Polyunsaturated fatty acids, Echium oil, Hyperlipidemias, Metabolites, Gut Microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Jun 2018 (estimated)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 2 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo oil | Placebo comparator | Dietary Supplement: Placebo oilIngredients: Corn oil, 500mg per capsule |
| Echium oil | Experimental | Dietary Supplement: Echium oilIngredients: Echium oil,500mg per capsule |
| Mixed oil | Experimental | Dietary Supplement: Mixed oilIngredients:Mixed oil(Echium oil,camelina oil,safflower oil) 500mg per capsule |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)]
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo oilThe 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. | Dietary supplement | Placebo oil |
| Echium oilThe 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. | Dietary supplement | Echium oil |
| Mixed oilThe 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. | Dietary supplement | Mixed oil |
Primary outcome
Changes in blood lipids profile
Time frame: At 0 week, 4th week, 12th week in intervention period
Fasting serum total cholesterol, low density lipoprotein, high density lipoprotein and triglycerides
Changes in vascular inflammation markers
Time frame: At 0 week, 4th week, 12th week in intervention period
Fasting plasma C-reactive protein, soluble intercellular adhesion molecule-1, soluble vascular cell adhesion molecule-1, soluble E-selectin
4 secondary outcomes
Changes in plasma metabolites
Time frame: At 0 week, 4th week, 12th week in intervention period
Changes of microbiota metabolite in fecal
Time frame: At 0 week, 4th week, 12th week in intervention period
Changes in gut microbiota
Time frame: At 0 week, 4th week, 12th week in intervention period
single nucleotide polymorphism genotype
Time frame: At 0 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiawei Yin contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echium oil and Mixed oil in people with Hyperlipidemias, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liegang Liu, MD，PhD (+86-27-83650522, liegangliu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in blood lipids profile (time frame: At 0 week, 4th week, 12th week in intervention period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2018.