Effects of DHA on Pro-resolving Anti-inflammatory Mediators in Obese Patients Undergoing Weight-loss Treatment
NCT ID: NCT01865448
Last Updated: 2019-06-20
Study Results
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View full resultsBasic Information
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COMPLETED
NA
34 participants
INTERVENTIONAL
2013-05-31
2015-03-31
Brief Summary
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Detailed Description
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Patients who are being treated with acetylsalicylic acid (ASA), non-steroidal anti-inflammatory drugs (NSAIDS), corticoids or thiazolidinedione antidiabetic drugs (glitazones); and patients with immune disorders (rheumatoid arthritis, Lupus, etc.) and/or inflammatory disease (ulcerative colitis, Crohn's disease, etc.) who may alter the biological markers of inflammation,will be excluded.
Treatment: In addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme, the patients will receive an additional 500 mg/day supplement of DHA omega-3 fatty acids in capsule form (study group) or a placebo capsule (control group).
The follow up will be 6 months and patients will be monitored over the course of 6 control visits: baseline, 7 days, 15 days, 30 days, 60 days and 180 days.
The main objective is to assess the effectiveness of providing additional DHA supplements to increase the levels of pro-resolving and anti-inflammatory lipid mediators and decrease the biological markers of chronic inflammation in obese patients following a weight-loss programme.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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omega-3 DHA
Patients in this group will receive 500 mg/day supplement of DHA omega-3 fatty acid in capsule form, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme.
Omega-3 DHA
Patients take daily 2 tablets of Docosahexaenoic Acid
Control
Patients in control group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme
Placebo
Patients in control group take daily 2 placebo capsule
Interventions
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Omega-3 DHA
Patients take daily 2 tablets of Docosahexaenoic Acid
Placebo
Patients in control group take daily 2 placebo capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Protein Supplies SL
OTHER
Responsible Party
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Principal Investigators
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Daniel De Luis, PhD
Role: PRINCIPAL_INVESTIGATOR
Unidad de Apoyo a la Investigacion. Hospital Rio Hortega
Locations
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Research Support Unit. Río Hortega University Hospital
Valladolid, , Spain
Countries
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Other Identifiers
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PNK-DHA-2013-01
Identifier Type: -
Identifier Source: org_study_id
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