Status:
COMPLETED
Effects of DHA on Pro-resolving Anti-inflammatory Mediators in Obese Patients Undergoing Weight-loss Treatment
Lead Sponsor:
Protein Supplies SL
Conditions:
Obesity
Inflammation
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Comparative, randomized, placebo-controlled, single-centre, single-blind clinical trial to assess the effectiveness of providing additional DHA omega-3 fatty acids supplements to increase the levels o...
Detailed Description
Will include obese patients (BMI between 30 and 35) who are following a standardized, multidisciplinary weight-loss programme (PronoKal® Method), which consists of a very-low-calorie diet based on pro...
Eligibility Criteria
Inclusion
- Age between 18 and 75 years
- Obese patients with Body Mass Index between 30 and 35
- Patients who, regardless of their inclusion in this study, are going to follow the standardized weight-loss programme (PronoKal® Method)
- Patients who agree to participate and sign the Informed Consent form
Exclusion
- Treatment with Omega-3 fatty acid supplements for other reasons during the month prior to inclusion in the trial
- Treatment with acetylsalicylic acid (ASA), non-steroidal anti-inflammatory drugs (NSAIDS), corticoids or thiazolidinedione antidiabetic drugs (glitazones)
- Pregnant or nursing patients
- Haemopathy, including clotting disorders
- Treatment with dicoumarin anticoagulants (Sintrom®)
- Cancer or a history of cancer who have not received the oncologist's release
- Type 1 or type 2 diabetes mellitus
- Immune disorders (rheumatoid arthritis, lupus, etc.) and/or inflammatory disease (ulcerative colitis, Crohn's disease, etc.) that may alter the biological markers of inflammation
- Patients not expected to attend monitoring visits
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01865448
Start Date
May 1 2013
End Date
March 1 2015
Last Update
June 20 2019
Active Locations (1)
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1
Research Support Unit. Río Hortega University Hospital
Valladolid, Spain