Clinical trial NCT01865448: Effects of DHA on Pro-resolving Anti-inflammatory Mediators in Obese Patients Undergoing Weight-loss Treatment
Official title: Study to Assess the Effects of DHA (Docosahexaenoic Acid) on Pro-resolving Anti-inflammatory Mediators in Obese Patients Undergoing Weight-loss Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Inflammation
Keywords: Docosahexaenoic Acids
Fatty Acids, Omega-3
Obesity
Inflammation
Lead sponsor: Protein Supplies SL
Sponsor class: OTHER
First posted: 2013-05-30
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proresolution Index
timeFrame: 6 months
measure: Sum of Proresolving Mediators at 6 Months
timeFrame: 6 months
measure: Sum of Proinflammatory Mediators at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Weight at 6 Months
timeFrame: 6 months
measure: Body Mass Index at 6 Months
timeFrame: 6 months
measure: Waist Circumference at 6 Months
timeFrame: 6 months
measure: C-reactive Protein (CRP) at 2 Months
timeFrame: 2 months
measure: C-reactive Protein (CRP) at 6 Months
timeFrame: 6 months
measure: Adiponectin at 2 Months
timeFrame: 2 months
measure: Adiponectin at 6 Months
timeFrame: 6 months
measure: Tnf Alpha at 2 Months
timeFrame: 2 months
measure: Tnf Alpha at 6 Months
timeFrame: 6 months
measure: Interleukin-6 at 2 Months
timeFrame: 2 months
measure: Interleukin-6 at 6 Months
timeFrame: 6 months
measure: Resistin at 2 Months
timeFrame: 2 months
measure: Resistin at 6 Months
timeFrame: 6 months
measure: Leptin at 2 Months
timeFrame: 2 months
measure: Leptin at 6 Months
timeFrame: 6 months
measure: 15-HETE at 2 Months
timeFrame: 2 months
measure: 15-HETE at 6 Months
timeFrame: 6 months
measure: 12-HETE at 2 Months
timeFrame: 2 month
measure: 12-HETE at 6 Months
timeFrame: 6 months
measure: 8-HETE at 2 Months
timeFrame: 2 months
measure: 8-HETE at 6 Months
timeFrame: 6 months
measure: 5-HETE at 2 Months
timeFrame: 2 months
measure: 5-HETE at 6 Months
timeFrame: 6 months
measure: TXB2 at 2 Months
timeFrame: 2 months
measure: TXB2 at 6 Months
timeFrame: 6 months
measure: PGE2 at 2 Months
timeFrame: 2 months
measure: PGE2 at 6 Months
timeFrame: 6 months
measure: LTB4 at 2 Months
timeFrame: 2 months
measure: LTB4 at 6 Months
timeFrame: 6 months
measure: 17-HDOHE at 2 Months
timeFrame: 2 months
measure: 17-HDOHE at 6 Months
timeFrame: 6 months
measure: 14-HDOHE at 2 Months
timeFrame: 2 months
measure: 14-HDOHE at 6 Months
timeFrame: 6 months
measure: 7-HDOHE at 2 Months
timeFrame: 2 months
measure: 7-HDOHE at 6 Months
timeFrame: 6 months
measure: 4-HDOHE at 2 Months
timeFrame: 2 months
measure: 4-HDOHE at 6 Months
timeFrame: 6 months
measure: RVD2 at 2 Months
timeFrame: 2 months
measure: RVD2 at 6 Months
timeFrame: 6 months
measure: PD1 at 2 Months
timeFrame: 2 months
measure: PD1 at 6 Months
timeFrame: 6 months
measure: 7SMAR1 at 2 Months
timeFrame: 2 months
measure: 7SMAR1 at 6 Months
timeFrame: 6 months
measure: 7RMAR1 at 2 Months
timeFrame: 2 months
measure: 7RMAR1 at 6 Months
timeFrame: 6 months
measure: Sum of Proinflammatory Mediators at 2 Months
timeFrame: 2 months
measure: Sum of Proresolving Mediators at 2 Months
timeFrame: 2 months
measure: Proresolution Index
timeFrame: 2 months
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: 6 months
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Research Support Unit. Río Hortega University Hospital
Study officials:
affiliation: Unidad de Apoyo a la Investigacion. Hospital Rio Hortega
name: Daniel De Luis, PhD
role: PRINCIPAL_INVESTIGATOR
References: