We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov Menu

n-3 Polyunsaturated Fatty Acids in Obesity (PUFA-ATI)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: September 26, 2008
Last Update Posted: March 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
National Bank of Austria
Information provided by (Responsible Party):
Thomas M Stulnig, Medical University of Vienna
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.

Condition Intervention Phase
Adipose Tissue Inflammation Morbid Obesity Drug: reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA) Drug: control Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Impact of n-3 Polyunsaturated Fatty Acids on Adipose Tissue Inflammation in Morbidly Obese Patients

Resource links provided by NLM:

Further study details as provided by Thomas M Stulnig, Medical University of Vienna:

Primary Outcome Measures:
  • Adipose tissue inflammation [ Time Frame: Eight weeks of treatment ]

Secondary Outcome Measures:
  • Metabolic control [ Time Frame: Eight weeks of treatment ]
  • Dependence of effects on Pparg polymorphisms [ Time Frame: Eight weeks of treatment ]

Enrollment: 55
Study Start Date: September 2008
Study Completion Date: March 2016
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: n-3 PUFA Drug: reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA)
4g daily, 8 weeks
Other Name: Omacor®
Placebo Comparator: Control Drug: control
equivalent amount of fat as butter


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00760760

Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
National Bank of Austria
Principal Investigator: Thomas M Stulnig, MD Medical University of Vienna
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas M Stulnig, Associate Professor, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00760760     History of Changes
Other Study ID Numbers: PUFA-ATI1
First Submitted: September 25, 2008
First Posted: September 26, 2008
Last Update Posted: March 16, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms
Pathologic Processes

To Top