n-3 Polyunsaturated Fatty Acids in Obesity

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

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2016-03-31

Brief Summary

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

Inflammation in the adipose (fat) tissue is an important condition leading to metabolic derangements and cardiovascular disease in obese patients. n-3 polyunsaturated fatty acids exert anti-inflammatory effects and prevent adipose tissue inflammation in rodent obesity. This study tests the hypothesis that n-3 polyunsaturated fatty acids ameliorate adipose tissue inflammation in morbidly obese patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Impact of n-3 Polyunsaturated Fatty Acids in a Protein-enriched Diet With Low GI in Type 2 Diabetes Patients

NCT01474603

Overweight Obese Insulin Resistance +1 more

COMPLETED

Intake of Omega 3 in Morbidly Obese Patients

NCT02113696

Morbid Obesity

COMPLETED NA

Effects of DHA on Pro-resolving Anti-inflammatory Mediators in Obese Patients Undergoing Weight-loss Treatment

NCT01865448

Obesity Inflammation

COMPLETED NA

The Impact of Fish-oil Fatty Acids on Postprandial Vascular Reactivity

NCT01692431

Cardiovascular Physiological Phenomena Endothelial Nitric Oxide Synthase Eicosapentaenoic Acid +1 more

COMPLETED NA

A Phase II Randomized Trial of Fish Oil in Patients With Acute Lung Injury (ALI)

NCT00351533

Respiratory Distress Syndrome, Adult Acute Lung Injury Acute Respiratory Distress Syndrome

COMPLETED PHASE2

Detailed Description

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

Conditions

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

Adipose Tissue Inflammation Morbid Obesity

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

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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

n-3 PUFA

Group Type EXPERIMENTAL

reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA)

Intervention Type DRUG

4g daily, 8 weeks

Control

Group Type PLACEBO_COMPARATOR

control

Intervention Type DRUG

equivalent amount of fat as butter

Interventions

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

reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA)

4g daily, 8 weeks

Intervention Type DRUG

control

equivalent amount of fat as butter

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Omacor®

Eligibility Criteria

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

Inclusion Criteria

* Non-diabetic morbidly obese patients (BMI \> 40 kg/m2) supposed to undergo bariatric surgery
* Age 20-65 yrs

Exclusion Criteria

* Acute illness within the last two week
* Known diabetes mellitus or current anti-diabetic medication
* Acquired immunodeficiency (HIV infection)
* Hepatitis or other significant liver disease
* Severe or untreated cardiovascular, renal, pulmonary disease
* Untreated or inadequately treated clinically significant thyroid disease
* Anemia
* Active malignant disease
* Inborn or acquired bleeding disorder including warfarin treatment
* Pregnancy or breast feeding
* Drug intolerability that prohibits the use of the study drug

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No