Effects of Omega-3 Fatty Acids on Markers of Inflammation

NCT ID: NCT01129050

Last Updated: 2023-02-22

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The major purpose of this study is to examine the effect of two sources of dietary omega-3 fatty acids, each given at two doses, on potential health benefits related to cardiovascular disease prevention. The two sources of dietary omega-3 fatty acids will be fish oil, and flaxseed oil.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The primary aim of this study is to examine the effect of two sources of dietary omega-3 fatty acids, each given at two doses, on potential health benefits related to cardiovascular disease prevention. The two sources of dietary omega-3 fatty acids will be fish oil, and flaxseed oil. Each will be given at a lower dose that could realistically be achieved from food sources alone, and at a higher dose that could not realistically be achieved from food alone and would require supplementation. The outcomes being studied are markers of inflammation. The subjects being studied are those with elevated risk factors for diabetes and heart disease that meet the criteria for the "metabolic syndrome". These are the people who are currently not diabetic, and who have not been diagnosed yet with heart disease, who are at risk of developing these diseases and who would likely benefit the most from the omega-3 therapy should it prove to be effective.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Hypertriglyceridemia Insulin Resistance Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low-dose Flaxseed Oil

2.2 g ALA (alpha-linolenic acid) per day

Group Type EXPERIMENTAL

Flaxseed Oil

Intervention Type DIETARY_SUPPLEMENT

Flaxseed oil capsule

High-dose Flaxseed Oil

6.6 g ALA (alpha-linolenic acid) per day

Group Type EXPERIMENTAL

Flaxseed Oil

Intervention Type DIETARY_SUPPLEMENT

Flaxseed oil capsule

Low-dose Fish Oil

1.2 g EPA+DHA (700 mg EPA and 500 mg DHA) per day

Group Type EXPERIMENTAL

Fish Oil

Intervention Type DIETARY_SUPPLEMENT

Fish oil capsule

High-dose Fish Oil

3.6 g EPA+DHA (2.1 g EPA and 1.5 g DHA) per day

Group Type EXPERIMENTAL

Fish Oil

Intervention Type DIETARY_SUPPLEMENT

Fish oil capsule

Placebo

4 g or 6 g soybean oil per day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Soybean oil capsule

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fish Oil

Fish oil capsule

Intervention Type DIETARY_SUPPLEMENT

Flaxseed Oil

Flaxseed oil capsule

Intervention Type DIETARY_SUPPLEMENT

Placebo

Soybean oil capsule

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Both women and men
* Age: \> or = 18 years
* Ethnicity and race: All ethnic and racial backgrounds welcome
* As defined in ATP III of the National Cholesterol Education program, the metabolic syndrome will be diagnosed as presence of at least three of the following, which will be measured at the screening clinic visit:

Central obesity as measured by waist circumference:

* Men: Greater than 40 inches
* Women: Greater than 35 inches

* Fasting blood triglycerides greater than or equal to 150 mg/dL
* Blood HDL cholesterol:
* Men: Less than 40 mg/dL
* Women: Less than 50 mg/dL

* Blood pressure greater than or equal to 130/85 mmHg

* Fasting glucose greater than or equal to 100 mg/dL

Planning to be available for clinic visits and bottle pick-ups for the 8 weeks of study participation

Ability and willingness to give written informed consent

No known active psychiatric illness.

Exclusion Criteria

* Fasting blood glucose \> 140 mg/dL
* Significant liver enzyme abnormality
* AST or ALT more than 2 times the upper limit of normal and/or
* Bilirubin more than 50% the upper limit of normal
* Renal disease as measured at baseline:
* Serum creatinine \> 1.30 mg/dL, or
* Calculated creatinine clearance \< 71 mL/min
* Self reported personal history of:

* Clotting disorders
* Clinically significant atherosclerosis (e.g., CAD, PAD)
* Malignant neoplasm
* Ongoing infection
* Inflammatory disease (e.g., rheumatoid arthritis)
* Subjects currently receiving the following medications (self report):

* Anti-Inflammatory drugs
* Lipid lowering drugs including statins
* Anti-hypertensive drugs
* Anti-coagulant drugs
* Body Mass Index (BMI) greater than or equal to 40.
* Pregnant or Lactating
* Inability to communicate effectively with study personnel
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Christopher Gardner

Professor of Medicine (Research)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christopher D Gardner

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Dewell A, Marvasti FF, Harris WS, Tsao P, Gardner CD. Low- and high-dose plant and marine (n-3) fatty acids do not affect plasma inflammatory markers in adults with metabolic syndrome. J Nutr. 2011 Dec;141(12):2166-71. doi: 10.3945/jn.111.142240. Epub 2011 Oct 26.

Reference Type RESULT
PMID: 22031659 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R21AT003465-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SU-05042010-5842

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.