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

Protein Supplies SL

Status: Completed

Conditions: Inflammation; Obesity

Treatments: Other: Placebo; Dietary Supplement: Omega-3 DHA

Study type: Interventional

Funder types: Other

Identifiers

NCT01865448

PNK-DHA-2013-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups, including a placebo group

omega-3 DHA

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Omega-3 DHA

Control

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo