Effects of DHA on Pro-resolving Anti-inflammatory Mediators in Obese Patients Undergoing Weight-loss Treatment

Study Overview
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Brief Summary
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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 of pro-resolving and anti-inflammatory lipid mediators and decrease the biological markers of chronic inflammation in obese patients following a weight-loss programme.

Detailed Description
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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.

Official Title
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Study to Assess the Effects of DHA (Docosahexaenoic Acid) on Pro-resolving Anti-inflammatory Mediators in Obese Patients Undergoing Weight-loss Treatment

Conditions
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Obesity, Inflammation

Intervention / Treatment
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* Dietary Supplement: Omega-3 DHA
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: omega-3 DHA<br>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. | Dietary Supplement: Omega-3 DHA<br>* Patients take daily 2 tablets of Docosahexaenoic Acid<br>* Other names: PUFA;|
| Placebo Comparator: Control<br>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 | Other: Placebo<br>* Patients in control group take daily 2 placebo capsule<br>* Other names: placebo capsule;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proresolution Index | Proresolution index is the ratio of sum of proresolving mediators/sum of proinflammatory mediators | 6 months | 
| Sum of Proresolving Mediators at 6 Months | Sum of proresolving mediators at 6 months | 6 months | 
| Sum of Proinflammatory Mediators at 6 Months | Sum of proinflammatory mediators at 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight at 6 Months | Weight at 6 months (end of the monitoring period) | 6 months | 
| Body Mass Index at 6 Months | Body mass index at 6 months (end of the monitoring period) | 6 months | 
| Waist Circumference at 6 Months | Waist circumference at 6 Months (end of the monitoring period) | 6 months | 
| C-reactive Protein (CRP) at 2 Months | Level of c-reactive protein (CRP) at 2 months | 2 months | 
| C-reactive Protein (CRP) at 6 Months | Level of c.reactive protein (CRP) at 6 months | 6 months | 
| Adiponectin at 2 Months | Level of Adiponectin at 2 months | 2 months | 
| Adiponectin at 6 Months | Level of Adiponectin at 6 months | 6 months | 
| Tnf Alpha at 2 Months | Level of Tnf alpha at 2 months | 2 months | 
| Tnf Alpha at 6 Months | Level of Tnf alpha at 6 months | 6 months | 
| Interleukin-6 at 2 Months | Level of Interleukin-6 at 2 months | 2 months | 
| Interleukin-6 at 6 Months | Level of Interleukin-6 at 6 months | 6 months | 
| Resistin at 2 Months | Level of Resistin at 2 months | 2 months | 
| Resistin at 6 Months | Level of Resistin at 6 months | 6 months | 
| Leptin at 2 Months | Level of Leptin at 2 months | 2 months | 
| Leptin at 6 Months | Level of Leptin at 6 months | 6 months | 
| 15-HETE at 2 Months | Level of 15-HETE at 2 months | 2 months | 
| 15-HETE at 6 Months | Level of 15-HETE at 6 months | 6 months | 
| 12-HETE at 2 Months | Level 12-HETE at 2 months | 2 month | 
| 12-HETE at 6 Months | Level of 12-HETE at 6 months | 6 months | 
| 8-HETE at 2 Months | Level of 8-HETE at 2 months | 2 months | 
| 8-HETE at 6 Months | Level of 8-HETE at 6 months | 6 months | 
| 5-HETE at 2 Months | Level of 5-HETE at 2 months | 2 months | 
| 5-HETE at 6 Months | Level of 5-HETE at 6 months | 6 months | 
| TXB2 at 2 Months | Level of TXB2 at 2 months | 2 months | 
| TXB2 at 6 Months | Level of TXB2 at 6 months | 6 months | 
| PGE2 at 2 Months | Level of PGE2 at 2 months | 2 months | 
| PGE2 at 6 Months | Level of PGE2 at 6 months | 6 months | 
| LTB4 at 2 Months | Level of LTB4 at 2 months | 2 months | 
| LTB4 at 6 Months | Level of LTB4 at 6 months | 6 months | 
| 17-HDOHE at 2 Months | Level of 17-HDOHE at 2 months | 2 months | 
| 17-HDOHE at 6 Months | Level of 17-HDOHE at 6 months | 6 months | 
| 14-HDOHE at 2 Months | Level of 14-HDOHE at 2 months | 2 months | 
| 14-HDOHE at 6 Months | Level of 14-HDOHE at 6 months | 6 months | 
| 7-HDOHE at 2 Months | Level of 7-HDOHE at 2 months | 2 months | 
| 7-HDOHE at 6 Months | Level of 7-HDOHE at 6 months | 6 months | 
| 4-HDOHE at 2 Months | Level of 4-HDOHE at 2 months | 2 months | 
| 4-HDOHE at 6 Months | Level of 4-HDOHE at 6 months | 6 months | 
| RVD2 at 2 Months | Level of RVD2 at 2 motnhs | 2 months | 
| RVD2 at 6 Months | Level of RVD2 at 6 months | 6 months | 
| PD1 at 2 Months | Level of PD1 at 2 months | 2 months | 
| PD1 at 6 Months | Level of PD1 at 6 months | 6 months | 
| 7SMAR1 at 2 Months | Level of 7SMAR1 at 2 months | 2 months | 
| 7SMAR1 at 6 Months | Level of 7SMAR1 at 6 months | 6 months | 
| 7RMAR1 at 2 Months | Level of 7RMAR1 at 2 months | 2 months | 
| 7RMAR1 at 6 Months | Level of 7RMAR1 at 6 months | 6 months | 
| Sum of Proinflammatory Mediators at 2 Months | sum of proinflammatory mediators at 2 months | 2 months | 
| Sum of Proresolving Mediators at 2 Months | sum of proresolving mediators at 2 months | 2 months | 
| Proresolution Index | Proresolution index is the ratio of sum of proresolving mediators/sum of proinflammatory mediators | 2 months | 
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 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 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Docosahexaenoic Acids, Fatty Acids, Omega-3, Obesity, Inflammation