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

Protein Supplies SL34 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Obesity Inflammation

Interventions

Omega-3 DHADIETARY_SUPPLEMENT

Patients take daily 2 tablets of Docosahexaenoic Acid

PlaceboOTHER

Patients in control group take daily 2 placebo capsule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Support Unit. Río Hortega University Hospital

Valladolid, Spain

Outcomes

Primary Outcomes

Proresolution Index

Proresolution index is the ratio of sum of proresolving mediators/sum of proinflammatory mediators

Time frame: 6 months

Sum of Proresolving Mediators at 6 Months

Sum of proresolving mediators at 6 months

Time frame: 6 months

Sum of Proinflammatory Mediators at 6 Months

Sum of proinflammatory mediators at 6 months

Time frame: 6 months

Secondary Outcomes

Weight at 6 Months

Weight at 6 months (end of the monitoring period)

Time frame: 6 months

Body Mass Index at 6 Months

Body mass index at 6 months (end of the monitoring period)

Time frame: 6 months

Waist Circumference at 6 Months

Waist circumference at 6 Months (end of the monitoring period)

Time frame: 6 months

C-reactive Protein (CRP) at 2 Months

Level of c-reactive protein (CRP) at 2 months

Time frame: 2 months

C-reactive Protein (CRP) at 6 Months

Level of c.reactive protein (CRP) at 6 months

Time frame: 6 months

Adiponectin at 2 Months

Level of Adiponectin at 2 months

Data from ClinicalTrials.gov

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Time frame: 2 months

Adiponectin at 6 Months

Level of Adiponectin at 6 months

Time frame: 6 months

Tnf Alpha at 2 Months

Level of Tnf alpha at 2 months

Time frame: 2 months

Tnf Alpha at 6 Months

Level of Tnf alpha at 6 months

Time frame: 6 months

Interleukin-6 at 2 Months

Level of Interleukin-6 at 2 months

Time frame: 2 months

Interleukin-6 at 6 Months

Level of Interleukin-6 at 6 months

Time frame: 6 months

Resistin at 2 Months

Level of Resistin at 2 months

Time frame: 2 months

Resistin at 6 Months

Level of Resistin at 6 months

Time frame: 6 months

Leptin at 2 Months

Level of Leptin at 2 months

Time frame: 2 months

Leptin at 6 Months

Level of Leptin at 6 months

Time frame: 6 months

15-HETE at 2 Months

Level of 15-HETE at 2 months

Time frame: 2 months

15-HETE at 6 Months

Level of 15-HETE at 6 months

Time frame: 6 months

12-HETE at 2 Months

Level 12-HETE at 2 months

Time frame: 2 month

12-HETE at 6 Months

Level of 12-HETE at 6 months

Time frame: 6 months

8-HETE at 2 Months

Level of 8-HETE at 2 months

Time frame: 2 months

8-HETE at 6 Months

Level of 8-HETE at 6 months

Time frame: 6 months

5-HETE at 2 Months

Level of 5-HETE at 2 months

Time frame: 2 months

5-HETE at 6 Months

Level of 5-HETE at 6 months

Time frame: 6 months

TXB2 at 2 Months

Level of TXB2 at 2 months

Time frame: 2 months

TXB2 at 6 Months

Level of TXB2 at 6 months

Time frame: 6 months

PGE2 at 2 Months

Level of PGE2 at 2 months

Time frame: 2 months

PGE2 at 6 Months

Level of PGE2 at 6 months

Time frame: 6 months

LTB4 at 2 Months

Level of LTB4 at 2 months

Time frame: 2 months

LTB4 at 6 Months

Level of LTB4 at 6 months

Time frame: 6 months

17-HDOHE at 2 Months

Level of 17-HDOHE at 2 months

Time frame: 2 months

17-HDOHE at 6 Months

Level of 17-HDOHE at 6 months

Time frame: 6 months

14-HDOHE at 2 Months

Level of 14-HDOHE at 2 months

Time frame: 2 months

14-HDOHE at 6 Months

Level of 14-HDOHE at 6 months

Time frame: 6 months

7-HDOHE at 2 Months

Level of 7-HDOHE at 2 months

Time frame: 2 months

7-HDOHE at 6 Months

Level of 7-HDOHE at 6 months

Time frame: 6 months

4-HDOHE at 2 Months

Level of 4-HDOHE at 2 months

Time frame: 2 months

4-HDOHE at 6 Months

Level of 4-HDOHE at 6 months

Time frame: 6 months

RVD2 at 2 Months

Level of RVD2 at 2 motnhs

Time frame: 2 months

RVD2 at 6 Months

Level of RVD2 at 6 months

Time frame: 6 months

PD1 at 2 Months

Level of PD1 at 2 months

Time frame: 2 months

PD1 at 6 Months

Level of PD1 at 6 months

Time frame: 6 months

7SMAR1 at 2 Months

Level of 7SMAR1 at 2 months

Time frame: 2 months

7SMAR1 at 6 Months

Level of 7SMAR1 at 6 months

Time frame: 6 months

7RMAR1 at 2 Months

Level of 7RMAR1 at 2 months

Time frame: 2 months

7RMAR1 at 6 Months

Level of 7RMAR1 at 6 months

Time frame: 6 months

Sum of Proinflammatory Mediators at 2 Months

sum of proinflammatory mediators at 2 months

Time frame: 2 months

Sum of Proresolving Mediators at 2 Months

sum of proresolving mediators at 2 months

Time frame: 2 months

Proresolution Index

Proresolution index is the ratio of sum of proresolving mediators/sum of proinflammatory mediators

Time frame: 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

Time frame: 6 months