Title
Effects of DHA on Pro-resolving Anti-inflammatory Mediators in Obese Patients Undergoing Weight-loss Treatment
Study to Assess the Effects of DHA (Docosahexaenoic Acid) on Pro-resolving Anti-inflammatory Mediators in Obese Patients Undergoing Weight-loss Treatment
Phase
Phase 4Lead Sponsor
PronoKal FoundationStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Obesity InflammationIntervention/Treatment
icosapent ethyl ...Study Participants
34Comparative, 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 of pro-resolving and anti-inflammatory lipid mediators and decrease the biological markers of chronic inflammation in obese patients following a weight-loss programme.
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 protein packets and vegetables with a low glycemic index, into which natural foods are gradually reintroduced, accompanied by physical exercise and emotional support.
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.
Patients take daily 2 tablets of Docosahexaenoic Acid
Patients in control group take daily 2 placebo capsule
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.
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
Inclusion Criteria: 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 Criteria: 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
| Event Type | Organ System | Event Term | Control | Omega-3 DHA |
|---|
Sum of proresolving mediators at 6 months
Sum of proinflammatory mediators at 6 months
Proresolution index is the ratio of sum of proresolving mediators/sum of proinflammatory mediators
Weight at 6 months (end of the monitoring period)
Body mass index at 6 months (end of the monitoring period)
Waist circumference at 6 Months (end of the monitoring period)
Level of c-reactive protein (CRP) at 2 months
Level of c.reactive protein (CRP) at 6 months
Level of Adiponectin at 2 months
Level of Adiponectin at 6 months
Level of Tnf alpha at 2 months
Level of Tnf alpha at 6 months
Level of Interleukin-6 at 2 months
Level of Interleukin-6 at 6 months
Level of Resistin at 2 months
Level of Resistin at 6 months
Level of Leptin at 2 months
Level of Leptin at 6 months
Level of 15-HETE at 2 months
Level of 15-HETE at 6 months
Level 12-HETE at 2 months
Level of 12-HETE at 6 months
Level of 8-HETE at 2 months
Level of 8-HETE at 6 months
Level of 5-HETE at 2 months
Level of 5-HETE at 6 months
Level of TXB2 at 2 months
Level of TXB2 at 6 months
Level of PGE2 at 2 months
Level of PGE2 at 6 months
Level of LTB4 at 6 months
Level of 17-HDOHE at 2 months
Level of 17-HDOHE at 6 months
Level of 14-HDOHE at 2 months
Level of 14-HDOHE at 6 months
Level of 7-HDOHE at 2 months
Level of 7-HDOHE at 6 months
Level of RVD2 at 2 motnhs
Level of RVD2 at 6 months
Level of PD1 at 2 months
Level of PD1 at 6 months
Level of 7SMAR1 at 2 months
Level of 7SMAR1 at 6 months
Level of 7RMAR1 at 2 months
Level of 7RMAR1 at 6 months
sum of proinflammatory mediators at 2 months
sum of proresolving mediators at 2 months
Proresolution index is the ratio of sum of proresolving mediators/sum of proinflammatory mediators
Level of LTB4 at 2 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of standardized weight-loss programme (PronoKal® Method)and Safety and Tolerability of DHA Supplements
Level of 4-HDOHE at 2 months
Level of 4-HDOHE at 6 months
