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

NCT ID: NCT03484988

Last Updated: 2018-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-30

Study Completion Date

2019-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hyperlipidemias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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).

Study Groups

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Placebo oil

Ingredients: Corn oil, 500mg per capsule

Group Type PLACEBO_COMPARATOR

Placebo oil

Intervention Type DIETARY_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 oil

Ingredients: Echium oil,500mg per capsule

Group Type EXPERIMENTAL

Echium oil

Intervention Type DIETARY_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 oil

Ingredients:Mixed oil(Echium oil,camelina oil,safflower oil) 500mg per capsule

Group Type EXPERIMENTAL

Mixed oil

Intervention Type DIETARY_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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Liegang Liu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status

Countries

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China

Central Contacts

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Liegang Liu, MD,PhD

Role: CONTACT

+86-27-83650522

Jiawei Yin

Role: CONTACT

Other Identifiers

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HPG2017102074

Identifier Type: -

Identifier Source: org_study_id

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