N/A
Completed N=34
Effects of DHA on Pro-resolving Anti-inflammatory Mediators in Obese Patients Undergoing Weight-loss Treatment
Source: ClinicalTrials.gov NCT01865448 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Proresolution Index — 0.71; 0.84 ratio — p=0.2780
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proresolution Index |
0.55; 0.72 | 0.0320 sig |
| PRIMARY Sum of Proresolving Mediators at 6 Months |
3342.11; 3409.31 | 0.9573 |
| PRIMARY Sum of Proinflammatory Mediators at 6 Months |
4276.89; 3931.00 | 0.7474 |
| SECONDARY Weight at 6 Months |
71.8; 72.3 | 0.71833 |
| SECONDARY Body Mass Index at 6 Months |
25.6; 26.2 | 0.51900 |
| SECONDARY Waist Circumference at 6 Months |
87.3; 89.0 | 0.24567 |
| SECONDARY C-reactive Protein (CRP) at 2 Months |
2.3; 3.2 | 0.27444 |
| SECONDARY C-reactive Protein (CRP) at 6 Months |
1.9; 2.1 | 0.28489 |
| SECONDARY Adiponectin at 2 Months |
11.3; 8.6 | 0.04491 sig |
| SECONDARY Adiponectin at 6 Months |
9.9; 7.9 | 0.24396 |
| SECONDARY Tnf Alpha at 2 Months |
3.1; 3.3 | 0.82322 |
| SECONDARY Tnf Alpha at 6 Months |
2.0; 2.0 | 0.76435 |
| SECONDARY Interleukin-6 at 2 Months |
4.0; 4.3 | 0.40485 |
| SECONDARY Interleukin-6 at 6 Months |
6.3; 4.9 | 0.13911 |
| SECONDARY Resistin at 2 Months |
4.7; 4.5 | 0.60214 |
| SECONDARY Resistin at 6 Months |
3.6; 3.4 | 0.66053 |
| SECONDARY Leptin at 2 Months |
5.8; 8.5 | 0.28743 |
| SECONDARY Leptin at 6 Months |
10.2; 15.8 | 0.58561 |
| SECONDARY 15-HETE at 2 Months |
101.37; 49.51 | 0.1953 |
| SECONDARY 15-HETE at 6 Months |
65.65; 72.95 | 0.6664 |
| SECONDARY 12-HETE at 2 Months |
6526.37; 5148.86 | 0.2470 |
| SECONDARY 12-HETE at 6 Months |
3652.28; 3226.87 | 0.6779 |
| SECONDARY 8-HETE at 2 Months |
92.05; 88.25 | 0.8591 |
| SECONDARY 8-HETE at 6 Months |
70.10; 82.88 | 0.3187 |
| SECONDARY 5-HETE at 2 Months |
512.39; 399.09 | 0.2813 |
| SECONDARY 5-HETE at 6 Months |
313.75; 369.10 | 0.2792 |
| SECONDARY TXB2 at 2 Months |
177.96; 149.31 | 0.7047 |
| SECONDARY TXB2 at 6 Months |
132.57; 148.01 | 0.5932 |
| SECONDARY PGE2 at 2 Months |
16.58; 5.58 | 0.2894 |
| SECONDARY PGE2 at 6 Months |
28.73; 13.31 | 0.3450 |
| SECONDARY LTB4 at 2 Months |
43.41; 1.49 | 0.2333 |
| SECONDARY LTB4 at 6 Months |
13.34; 16.31 | 0.6830 |
| SECONDARY 17-HDOHE at 2 Months |
172.24; 213.17 | 0.3694 |
| SECONDARY 17-HDOHE at 6 Months |
177.95; 286.03 | 0.1226 |
| SECONDARY 14-HDOHE at 2 Months |
3320.96; 3423.64 | 0.8969 |
| SECONDARY 14-HDOHE at 6 Months |
2760.07; 2575.02 | 0.8765 |
| SECONDARY 7-HDOHE at 2 Months |
118.46; 140.10 | 0.2914 |
| SECONDARY 7-HDOHE at 6 Months |
149.72; 190.58 | 0.0528 |
| SECONDARY 4-HDOHE at 2 Months |
298.81; 346.78 | 0.2999 |
| SECONDARY 4-HDOHE at 6 Months |
207.26; 306.24 | 0.0783 |
| SECONDARY RVD2 at 2 Months |
29.15; 23.16 | 0.6896 |
| SECONDARY RVD2 at 6 Months |
31.08; 31.73 | 0.9662 |
| SECONDARY PD1 at 2 Months |
3.70; 6.06 | 0.2643 |
| SECONDARY PD1 at 6 Months |
4.51; 6.31 | 0.1410 |
| SECONDARY 7SMAR1 at 2 Months |
NA; NA | <0.0001 sig |
| SECONDARY 7SMAR1 at 6 Months |
5.52; 7.35 | 0.5893 |
| SECONDARY 7RMAR1 at 2 Months |
NA; NA | <0.0001 sig |
| SECONDARY 7RMAR1 at 6 Months |
6.01; 6.05 | 0.9850 |
| SECONDARY Sum of Proinflammatory Mediators at 2 Months |
7470.14; 5842.09 | 0.1946 |
| SECONDARY Sum of Proresolving Mediators at 2 Months |
3943.32; 4152.90 | 0.7964 |
| SECONDARY Proresolution Index |
0.55; 0.72 | 0.0320 sig |
| SECONDARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
2; 0; 7; 7; 2; 6 | 0.72828 |
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
Data sourced from ClinicalTrials.gov (NCT01865448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.