n-3 Polyunsaturated Fatty Acids in Obesity (PUFA-ATI)
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ClinicalTrials.gov Identifier: NCT00760760 |
Recruitment Status :
Completed
First Posted : September 26, 2008
Last Update Posted : March 16, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Adipose Tissue Inflammation Morbid Obesity | Drug: reesterified long-chain n-3 polyunsaturated fatty acids (EPA, DHA) Drug: control | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 55 participants |
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 |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | March 2016 |

Arm | Intervention/treatment |
---|---|
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 |
- Adipose tissue inflammation [ Time Frame: Eight weeks of treatment ]
- Metabolic control [ Time Frame: Eight weeks of treatment ]
- Dependence of effects on Pparg polymorphisms [ Time Frame: Eight weeks of treatment ]

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Ages Eligible for Study: | 20 Years to 65 Years (Adult, Older 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

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
Austria | |
Medical University of Vienna | |
Vienna, Austria, 1090 |
Principal Investigator: | Thomas M Stulnig, MD | Medical University of Vienna |
Responsible Party: | Thomas M Stulnig, Associate Professor, Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT00760760 |
Other Study ID Numbers: |
PUFA-ATI1 OeNB12735 |
First Posted: | September 26, 2008 Key Record Dates |
Last Update Posted: | March 16, 2016 |
Last Verified: | March 2016 |
Obesity Obesity, Morbid Inflammation Overnutrition |
Nutrition Disorders Overweight Body Weight Pathologic Processes |