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

This study has been completed.
National Bank of Austria
Information provided by (Responsible Party):
Thomas M Stulnig, Medical University of Vienna Identifier:
First received: September 25, 2008
Last updated: March 14, 2016
Last verified: March 2016
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


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
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Please refer to this study by its identifier: 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 Identifier (NCT Number):
Responsible Party: Thomas M Stulnig, Associate Professor, Medical University of Vienna Identifier: NCT00760760     History of Changes
Other Study ID Numbers: PUFA-ATI1
Study First Received: September 25, 2008
Last Updated: March 14, 2016

Additional relevant MeSH terms:
Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms
Pathologic Processes processed this record on September 21, 2017