Effects of DHA on Pro-resolving Anti-inflammatory Mediators in Obese Patients Undergoing Weight-loss Treatment
- Conditions
- ObesityInflammation
- Interventions
- Other: PlaceboDietary Supplement: Omega-3 DHA
- Registration Number
- NCT01865448
- Lead Sponsor
- Protein Supplies SL
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Placebo 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 omega-3 DHA Omega-3 DHA 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.
- Primary Outcome Measures
Name Time Method Proresolution Index 6 months Proresolution index is the ratio of sum of proresolving mediators/sum of proinflammatory mediators
Sum of Proresolving Mediators at 6 Months 6 months Sum of proresolving mediators at 6 months
Sum of Proinflammatory Mediators at 6 Months 6 months Sum of proinflammatory mediators at 6 months
- Secondary Outcome Measures
Name Time Method C-reactive Protein (CRP) at 6 Months 6 months Level of c.reactive protein (CRP) at 6 months
Adiponectin at 2 Months 2 months Level of Adiponectin at 2 months
Adiponectin at 6 Months 6 months Level of Adiponectin at 6 months
Proresolution Index 2 months Proresolution index is the ratio of sum of proresolving mediators/sum of proinflammatory mediators
7RMAR1 at 6 Months 6 months Level of 7RMAR1 at 6 months
PD1 at 6 Months 6 months Level of PD1 at 6 months
Body Mass Index at 6 Months 6 months Body mass index at 6 months (end of the monitoring period)
Tnf Alpha at 2 Months 2 months Level of Tnf alpha at 2 months
C-reactive Protein (CRP) at 2 Months 2 months Level of c-reactive protein (CRP) at 2 months
Weight at 6 Months 6 months Weight at 6 months (end of the monitoring period)
Waist Circumference at 6 Months 6 months Waist circumference at 6 Months (end of the monitoring period)
Interleukin-6 at 2 Months 2 months Level of Interleukin-6 at 2 months
8-HETE at 6 Months 6 months Level of 8-HETE at 6 months
TXB2 at 2 Months 2 months Level of TXB2 at 2 months
15-HETE at 2 Months 2 months Level of 15-HETE at 2 months
15-HETE at 6 Months 6 months Level of 15-HETE at 6 months
5-HETE at 2 Months 2 months Level of 5-HETE at 2 months
TXB2 at 6 Months 6 months Level of TXB2 at 6 months
PGE2 at 2 Months 2 months Level of PGE2 at 2 months
LTB4 at 2 Months 2 months Level of LTB4 at 2 months
7-HDOHE at 2 Months 2 months Level of 7-HDOHE at 2 months
RVD2 at 2 Months 2 months Level of RVD2 at 2 motnhs
7SMAR1 at 2 Months 2 months Level of 7SMAR1 at 2 months
7SMAR1 at 6 Months 6 months Level of 7SMAR1 at 6 months
Tnf Alpha at 6 Months 6 months Level of Tnf alpha at 6 months
Resistin at 6 Months 6 months Level of Resistin at 6 months
Leptin at 2 Months 2 months Level of Leptin at 2 months
Leptin at 6 Months 6 months Level of Leptin at 6 months
12-HETE at 2 Months 2 month Level 12-HETE at 2 months
Interleukin-6 at 6 Months 6 months Level of Interleukin-6 at 6 months
Resistin at 2 Months 2 months Level of Resistin at 2 months
12-HETE at 6 Months 6 months Level of 12-HETE at 6 months
8-HETE at 2 Months 2 months Level of 8-HETE at 2 months
5-HETE at 6 Months 6 months Level of 5-HETE at 6 months
PGE2 at 6 Months 6 months Level of PGE2 at 6 months
14-HDOHE at 6 Months 6 months Level of 14-HDOHE at 6 months
RVD2 at 6 Months 6 months Level of RVD2 at 6 months
Sum of Proinflammatory Mediators at 2 Months 2 months sum of proinflammatory mediators at 2 months
Sum of Proresolving Mediators at 2 Months 2 months sum of proresolving mediators at 2 months
17-HDOHE at 2 Months 2 months Level of 17-HDOHE at 2 months
LTB4 at 6 Months 6 months Level of LTB4 at 6 months
17-HDOHE at 6 Months 6 months Level of 17-HDOHE at 6 months
14-HDOHE at 2 Months 2 months Level of 14-HDOHE at 2 months
7-HDOHE at 6 Months 6 months Level of 7-HDOHE at 6 months
4-HDOHE at 2 Months 2 months Level of 4-HDOHE at 2 months
4-HDOHE at 6 Months 6 months Level of 4-HDOHE at 6 months
PD1 at 2 Months 2 months Level of PD1 at 2 months
7RMAR1 at 2 Months 2 months Level of 7RMAR1 at 2 months
Number of Participants With Adverse Events as a Measure of Safety and Tolerability 6 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
Trial Locations
- Locations (1)
Research Support Unit. Río Hortega University Hospital
🇪🇸Valladolid, Spain