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

Study to Assess the Effects of DHA (Docosahexaenoic Acid) on Pro-resolving Anti-inflammatory Mediators in Obese Patients Undergoing Weight-loss Treatment

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01865448

Enrollment

Registered

2013-05-30

Start date

2013-05-31

Completion date

2015-03-31

Last updated

2019-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation, Obesity

Keywords

Docosahexaenoic Acids, Fatty Acids, Omega-3, Obesity, Inflammation

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.

Interventions

DIETARY_SUPPLEMENTOmega-3 DHA

Patients take daily 2 tablets of Docosahexaenoic Acid

OTHERPlacebo

Patients in control group take daily 2 placebo capsule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Adiponectin at 2 Months	2 months	Level of Adiponectin at 2 months
Adiponectin at 6 Months	6 months	Level of Adiponectin at 6 months
Tnf Alpha at 2 Months	2 months	Level of Tnf alpha at 2 months
Waist Circumference at 6 Months	6 months	Waist circumference at 6 Months (end of the monitoring period)
C-reactive Protein (CRP) at 2 Months	2 months	Level of c-reactive protein (CRP) at 2 months
C-reactive Protein (CRP) at 6 Months	6 months	Level of c.reactive protein (CRP) at 6 months
Interleukin-6 at 2 Months	2 months	Level of Interleukin-6 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
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
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
12-HETE at 2 Months	2 month	Level 12-HETE 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
8-HETE at 6 Months	6 months	Level of 8-HETE at 6 months
5-HETE at 2 Months	2 months	Level of 5-HETE at 2 months
5-HETE at 6 Months	6 months	Level of 5-HETE at 6 months
TXB2 at 2 Months	2 months	Level of TXB2 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
PGE2 at 6 Months	6 months	Level of PGE2 at 6 months
LTB4 at 2 Months	2 months	Level of LTB4 at 2 months
LTB4 at 6 Months	6 months	Level of LTB4 at 6 months
17-HDOHE at 2 Months	2 months	Level of 17-HDOHE at 2 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
14-HDOHE at 6 Months	6 months	Level of 14-HDOHE at 6 months
7-HDOHE at 2 Months	2 months	Level of 7-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
RVD2 at 2 Months	2 months	Level of RVD2 at 2 motnhs
RVD2 at 6 Months	6 months	Level of RVD2 at 6 months
PD1 at 2 Months	2 months	Level of PD1 at 2 months
PD1 at 6 Months	6 months	Level of PD1 at 6 months
7SMAR1 at 2 Months	2 months	Level of 7SMAR1 at 2 months
7SMAR1 at 6 Months	6 months	Level of 7SMAR1 at 6 months
7RMAR1 at 2 Months	2 months	Level of 7RMAR1 at 2 months
7RMAR1 at 6 Months	6 months	Level of 7RMAR1 at 6 months
Tnf Alpha at 6 Months	6 months	Level of Tnf alpha at 6 months
Sum of Proresolving Mediators at 2 Months	2 months	sum of proresolving mediators at 2 months
Proresolution Index	2 months	Proresolution index is the ratio of sum of proresolving mediators/sum of proinflammatory mediators
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
Sum of Proinflammatory Mediators at 2 Months	2 months	sum of proinflammatory mediators at 2 months
Weight at 6 Months	6 months	Weight at 6 months (end of the monitoring period)
Body Mass Index at 6 Months	6 months	Body mass index at 6 months (end of the monitoring period)

Countries

Spain

Participant flow

Recruitment details

Study performed in a single center. The patients attending the Endocrinology and Nutrition Department at the Hospital Clinico Universitario of Valladolid to receive treatment for obesity were consecutively enrolled in this study.

Participants by arm

Arm	Count
Control Patients in this group will receive an placebo capsule, in addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme	15
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. Omega-3 DHA: Patients take daily 2 tablets of placebo	14
Total	29

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	1	1
Overall Study	dropout unrelated to study	1	1
Overall Study	Pregnancy	0	1

Baseline characteristics

Characteristic	Control	Total	Omega-3 DHA
12 -HETE	4985.94 pg/ml STANDARD_DEVIATION 4301.86	5179.51 pg/ml STANDARD_DEVIATION 3803.27	5359.26 pg/ml STANDARD_DEVIATION 3431.47
14-HDOHE	3668.74 pg/ml STANDARD_DEVIATION 3540.69	3877.60 pg/ml STANDARD_DEVIATION 3285.03	4071.54 pg/ml STANDARD_DEVIATION 3150.66
15-HETE	51.14 pg/ml STANDARD_DEVIATION 84.24	36.9 pg/ml STANDARD_DEVIATION 64.8	23.76 pg/ml STANDARD_DEVIATION 38.35
17-HDOHE	96.56 pg/ml STANDARD_DEVIATION 87.7	115.93 pg/ml STANDARD_DEVIATION 84.7	133.92 pg/ml STANDARD_DEVIATION 80.78
4-HDOHE	268.36 pg/ml STANDARD_DEVIATION 148.25	279.03 pg/ml STANDARD_DEVIATION 145.27	288.93 pg/ml STANDARD_DEVIATION 147.32
5-HETE	424.39 pg/ml STANDARD_DEVIATION 209.93	396.00 pg/ml STANDARD_DEVIATION 163.78	369.63 pg/ml STANDARD_DEVIATION 106.82
7-HDOHE	128.55 pg/ml STANDARD_DEVIATION 52.83	124.55 pg/ml STANDARD_DEVIATION 50.08	120.83 pg/ml STANDARD_DEVIATION 49.09
7RMAR1	NA pg/ml	NA pg/ml	NA pg/ml
7SMAR1	NA pg/ml	NA pg/ml	NA pg/ml
8-HETE	43.74 pg/ml STANDARD_DEVIATION 42.24	51.06 pg/ml STANDARD_DEVIATION 46.85	57.85 pg/ml STANDARD_DEVIATION 51.38
Adiponectin (ng/ml)	8.6 ng/ml STANDARD_DEVIATION 4.2	8.3 ng/ml STANDARD_DEVIATION 3.8	7.9 ng/ml STANDARD_DEVIATION 3.5
Age, Continuous	44.3 years STANDARD_DEVIATION 11.7	45.8 years STANDARD_DEVIATION 10.4	47.4 years STANDARD_DEVIATION 9.1
Body Mass Index (BMI) (kg/m^2)	32.9 kg/m^2 STANDARD_DEVIATION 1.9	33.1 kg/m^2 STANDARD_DEVIATION 1.6	33.4 kg/m^2 STANDARD_DEVIATION 1.4
C-reactive Protein (CRP) (mg/dl)	3.3 mg/dl STANDARD_DEVIATION 1.4	3.6 mg/dl STANDARD_DEVIATION 2.5	3.8 mg/dl STANDARD_DEVIATION 3.4
Interleukin-6 (ng/ml)	4.2 ng/ml STANDARD_DEVIATION 2.1	4.2 ng/ml STANDARD_DEVIATION 1.8	4.1 ng/ml STANDARD_DEVIATION 1.7
Leptin (ng/ml)	29.7 ng/ml STANDARD_DEVIATION 17.7	37.2 ng/ml STANDARD_DEVIATION 21.2	45.2 ng/ml STANDARD_DEVIATION 22.4
LTB4	15.08 pg/ml STANDARD_DEVIATION 29.88	7.26 pg/ml STANDARD_DEVIATION 21.71	0.00 pg/ml STANDARD_DEVIATION 0
PD1	6.27 pg/ml STANDARD_DEVIATION 7.04	4.99 pg/ml STANDARD_DEVIATION 6.19	3.80 pg/ml STANDARD_DEVIATION 5.27
PGE2	2.82 pg/ml STANDARD_DEVIATION 6.93	1.43 pg/ml STANDARD_DEVIATION 4.91	0.14 pg/ml STANDARD_DEVIATION 0.34
Proresolution index	0.72 ratio STANDARD_DEVIATION 0.23	0.75 ratio STANDARD_DEVIATION 0.29	0.78 ratio STANDARD_DEVIATION 0.35
Region of Enrollment Spain	15 participants	29 participants	14 participants
Resistin (ng/ml)	5.3 ng/ml STANDARD_DEVIATION 3.6	4.9 ng/ml STANDARD_DEVIATION 2.9	4.5 ng/ml STANDARD_DEVIATION 2.2
RVD2	64.89 pg/ml STANDARD_DEVIATION 74.55	57.52 pg/ml STANDARD_DEVIATION 82.44	50.68 pg/ml STANDARD_DEVIATION 91.41
Sex: Female, Male Female	8 Participants	17 Participants	9 Participants
Sex: Female, Male Male	7 Participants	12 Participants	5 Participants
Sum of proinflammatory mediators	5641.30 pg/ml STANDARD_DEVIATION 4357.98	5797.16 pg/ml STANDARD_DEVIATION 3890.83	5941.89 pg/ml STANDARD_DEVIATION 3563.6
Sum of proresolving mediators	4233.38 pg/ml STANDARD_DEVIATION 3652.42	4459.61 pg/ml STANDARD_DEVIATION 3430.36	4669.69 pg/ml STANDARD_DEVIATION 3334.98
Tnf alpha (ng/ml)	4.7 ng/ml STANDARD_DEVIATION 2.3	4.8 ng/ml STANDARD_DEVIATION 2.3	5.0 ng/ml STANDARD_DEVIATION 2.5
TXB2	118.20 pg/ml STANDARD_DEVIATION 133.33	124.97 pg/ml STANDARD_DEVIATION 113.2	131.26 pg/ml STANDARD_DEVIATION 95.62
Waist circumference (cm)	109.2 cm STANDARD_DEVIATION 7.9	109.3 cm STANDARD_DEVIATION 7.7	109.4 cm STANDARD_DEVIATION 7.8
Weight (Kg)	92.2 Kg STANDARD_DEVIATION 13.1	92.1 Kg STANDARD_DEVIATION 10.9	92.1 Kg STANDARD_DEVIATION 8.7

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	9 / 17	11 / 17
serious Total, serious adverse events	0 / 17	0 / 17

Outcome results

Primary

Proresolution Index

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

Time frame: 6 months

Arm	Measure	Value (MEAN)	Dispersion
Control	Proresolution Index	0.71 ratio	Standard Deviation 0.27
Omega-3 DHA	Proresolution Index	0.84 ratio	Standard Deviation 0.36

Comparison: Between-Group Comparisonp-value: 0.278ANCOVA

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.8689Paired t-test

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.4533Paired t-test

Primary

Sum of Proinflammatory Mediators at 6 Months

Sum of proinflammatory mediators at 6 months

Time frame: 6 months

Arm	Measure	Value (MEAN)	Dispersion
Control	Sum of Proinflammatory Mediators at 6 Months	4276.89 pg/ml	Standard Deviation 35.89
Omega-3 DHA	Sum of Proinflammatory Mediators at 6 Months	3931.00 pg/ml	Standard Deviation 1654.83

Comparison: Between-Group Comparisonp-value: 0.7474ANCOVA

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.3745Paired t-test

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.0476Paired t-test

Primary

Sum of Proresolving Mediators at 6 Months

Sum of proresolving mediators at 6 months

Time frame: 6 months

Arm	Measure	Value (MEAN)	Dispersion
Control	Sum of Proresolving Mediators at 6 Months	3342.11 pg/ml	Standard Deviation 4132.21
Omega-3 DHA	Sum of Proresolving Mediators at 6 Months	3409.31 pg/ml	Standard Deviation 2065.58

Comparison: Between-Group Comparisonp-value: 0.9573ANCOVA

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.5257Paired t-test

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.0657Paired t-test

Secondary

12-HETE at 2 Months

Level 12-HETE at 2 months

Time frame: 2 month

Arm	Measure	Value (MEAN)	Dispersion
Control	12-HETE at 2 Months	6526.37 pg/ml	Standard Deviation 3922.55
Omega-3 DHA	12-HETE at 2 Months	5148.86 pg/ml	Standard Deviation 1817.86

Comparison: Between-Group Comparisonp-value: 0.247ANCOVA

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.2755Paired t-test

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.8226Paired t-test

Secondary

12-HETE at 6 Months

Level of 12-HETE at 6 months

Time frame: 6 months

Arm	Measure	Value (MEAN)	Dispersion
Control	12-HETE at 6 Months	3652.28 pg/ml	Standard Deviation 3488.85
Omega-3 DHA	12-HETE at 6 Months	3226.87 pg/ml	Standard Deviation 1431.22

Comparison: Between-Group Comparisonp-value: 0.6779ANCOVA

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.3761Paired t-test

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.0281Paired t-test

Secondary

14-HDOHE at 2 Months

Level of 14-HDOHE at 2 months

Time frame: 2 months

Arm	Measure	Value (MEAN)	Dispersion
Control	14-HDOHE at 2 Months	3320.96 pg/ml	Standard Deviation 2520.22
Omega-3 DHA	14-HDOHE at 2 Months	3423.64 pg/ml	Standard Deviation 1452.23

Comparison: Between-Group Comparisonp-value: 0.8969ANCOVA

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.7218Paired t-test

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.4536Paired t-test

Secondary

14-HDOHE at 6 Months

Level of 14-HDOHE at 6 months

Time frame: 6 months

Arm	Measure	Value (MEAN)	Dispersion
Control	14-HDOHE at 6 Months	2760.07 pg/ml	Standard Deviation 3984.42
Omega-3 DHA	14-HDOHE at 6 Months	2575.02 pg/ml	Standard Deviation 1833.92

Comparison: Between-Group Comparisonp-value: 0.8765ANCOVA

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.5114Paired t-test

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.0237Paired t-test

Secondary

15-HETE at 2 Months

Level of 15-HETE at 2 months

Time frame: 2 months

Arm	Measure	Value (MEAN)	Dispersion
Control	15-HETE at 2 Months	101.37 pg/ml	Standard Deviation 136.54
Omega-3 DHA	15-HETE at 2 Months	49.51 pg/ml	Standard Deviation 49.77

Comparison: Between-Group Comparisonp-value: 0.1953ANCOVA

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.0351Paired t-test

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.0795Paired t-test

Secondary

15-HETE at 6 Months

Level of 15-HETE at 6 months

Time frame: 6 months

Arm	Measure	Value (MEAN)	Dispersion
Control	15-HETE at 6 Months	65.65 pg/ml	Standard Deviation 32.65
Omega-3 DHA	15-HETE at 6 Months	72.95 pg/ml	Standard Deviation 51.5

Comparison: Between-Group Comparisonp-value: 0.6664ANCOVA

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.431Paired t-test

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.0049Paired t-test

Secondary

17-HDOHE at 2 Months

Level of 17-HDOHE at 2 months

Time frame: 2 months

Arm	Measure	Value (MEAN)	Dispersion
Control	17-HDOHE at 2 Months	172.24 pg/ml	Standard Deviation 123.32
Omega-3 DHA	17-HDOHE at 2 Months	213.17 pg/ml	Standard Deviation 109.31

Comparison: Between-Group Comparisonp-value: 0.3694ANCOVA

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.0291Paired t-test

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.0402Paired t-test

Secondary

17-HDOHE at 6 Months

Level of 17-HDOHE at 6 months

Time frame: 6 months

Arm	Measure	Value (MEAN)	Dispersion
Control	17-HDOHE at 6 Months	177.95 pg/ml	Standard Deviation 120.73
Omega-3 DHA	17-HDOHE at 6 Months	286.03 pg/ml	Standard Deviation 214.13

Comparison: Between-Group Comparisonp-value: 0.1226ANCOVA

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.0472Paired t-test

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.0197Paired t-test

Secondary

4-HDOHE at 2 Months

Level of 4-HDOHE at 2 months

Time frame: 2 months

Arm	Measure	Value (MEAN)	Dispersion
Control	4-HDOHE at 2 Months	298.81 pg/ml	Standard Deviation 102.32
Omega-3 DHA	4-HDOHE at 2 Months	346.78 pg/ml	Standard Deviation 130.19

Comparison: Between-Group Comparisonp-value: 0.2999ANCOVA

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.5184Paired t-test

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.0564Paired t-test

Secondary

4-HDOHE at 6 Months

Level of 4-HDOHE at 6 months

Time frame: 6 months

Arm	Measure	Value (MEAN)	Dispersion
Control	4-HDOHE at 6 Months	207.26 pg/ml	Standard Deviation 94.35
Omega-3 DHA	4-HDOHE at 6 Months	306.24 pg/ml	Standard Deviation 171.67

Comparison: Between-Group Comparisonp-value: 0.0783ANCOVA

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.1263Paired t-test

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.6484Paired t-test

Secondary

5-HETE at 2 Months

Level of 5-HETE at 2 months

Time frame: 2 months

Arm	Measure	Value (MEAN)	Dispersion
Control	5-HETE at 2 Months	512.39 pg/ml	Standard Deviation 362.39
Omega-3 DHA	5-HETE at 2 Months	399.09 pg/ml	Standard Deviation 126.57

Comparison: Between-Group Comparisonp-value: 0.2813ANCOVA

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.4421Paired t-test

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.3198Paired t-test

Secondary

5-HETE at 6 Months

Level of 5-HETE at 6 months

Time frame: 6 months

Arm	Measure	Value (MEAN)	Dispersion
Control	5-HETE at 6 Months	313.75 pg/ml	Standard Deviation 104.23
Omega-3 DHA	5-HETE at 6 Months	369.10 pg/ml	Standard Deviation 149.68

Comparison: Between-Group Comparisonp-value: 0.2792ANCOVA

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.1034Paired t-test

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.9898Paired t-test

Secondary

7-HDOHE at 2 Months

Level of 7-HDOHE at 2 months

Time frame: 2 months

Arm	Measure	Value (MEAN)	Dispersion
Control	7-HDOHE at 2 Months	118.46 pg/ml	Standard Deviation 42.42
Omega-3 DHA	7-HDOHE at 2 Months	140.10 pg/ml	Standard Deviation 59.71

Comparison: Between-Group Comparisonp-value: 0.2914ANCOVA

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.5594Paired t-test

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.2532Paired t-test

Secondary

7-HDOHE at 6 Months

Level of 7-HDOHE at 6 months

Time frame: 6 months

Arm	Measure	Value (MEAN)	Dispersion
Control	7-HDOHE at 6 Months	149.72 pg/ml	Standard Deviation 47.26
Omega-3 DHA	7-HDOHE at 6 Months	190.58 pg/ml	Standard Deviation 56.36

Comparison: Between-Group Comparisonp-value: 0.0528ANCOVA

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.192Paired t-test

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.0011Paired t-test

Secondary

7RMAR1 at 2 Months

Level of 7RMAR1 at 2 months

Time frame: 2 months

Arm	Measure	Value (MEAN)
Control	7RMAR1 at 2 Months	NA pg/ml
Omega-3 DHA	7RMAR1 at 2 Months	NA pg/ml

Comparison: Between-Group Comparisonp-value: <0.0001ANCOVA

Comparison: Within-group comparisons between the baseline and 2 month datap-value: <0.0001Paired t-test

Secondary

7RMAR1 at 6 Months

Level of 7RMAR1 at 6 months

Time frame: 6 months

Arm	Measure	Value (MEAN)	Dispersion
Control	7RMAR1 at 6 Months	6.01 pg/ml	Standard Deviation 3.29
Omega-3 DHA	7RMAR1 at 6 Months	6.05 pg/ml	Standard Deviation 6.95

Comparison: Between-Group Comparisonp-value: 0.985ANCOVA

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.0049Paired t-test

p-value: 0.0062Paired t-test

Secondary

7SMAR1 at 2 Months

Level of 7SMAR1 at 2 months

Time frame: 2 months

Arm	Measure	Value (MEAN)
Control	7SMAR1 at 2 Months	NA pg/ml
Omega-3 DHA	7SMAR1 at 2 Months	NA pg/ml

Comparison: Between-Group Comparisonp-value: <0.0001ANCOVA

Comparison: Within-group comparisons between the baseline and 2 month datap-value: <0.0001Paired t-test

Secondary

7SMAR1 at 6 Months

Level of 7SMAR1 at 6 months

Time frame: 6 months

Arm	Measure	Value (MEAN)	Dispersion
Control	7SMAR1 at 6 Months	5.52 pg/ml	Standard Deviation 8.81
Omega-3 DHA	7SMAR1 at 6 Months	7.35 pg/ml	Standard Deviation 8.52

Comparison: Between-Group Comparisonp-value: 0.5893ANCOVA

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.0431Paired t-test

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.0066Paired t-test

Secondary

8-HETE at 2 Months

Level of 8-HETE at 2 months

Time frame: 2 months

Arm	Measure	Value (MEAN)	Dispersion
Control	8-HETE at 2 Months	92.05 pg/ml	Standard Deviation 69.45
Omega-3 DHA	8-HETE at 2 Months	88.25 pg/ml	Standard Deviation 37

Comparison: Between-Group Comparisonp-value: 0.8591ANCOVA

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.0404Paired t-test

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.0474Paired t-test

Secondary

8-HETE at 6 Months

Level of 8-HETE at 6 months

Time frame: 6 months

Arm	Measure	Value (MEAN)	Dispersion
Control	8-HETE at 6 Months	70.10 pg/ml	Standard Deviation 28.45
Omega-3 DHA	8-HETE at 6 Months	82.88 pg/ml	Standard Deviation 36.02

Comparison: Between-Group Comparisonp-value: 0.3187ANCOVA

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.0482Paired t-test

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.0394Paired t-test

Secondary

Adiponectin at 2 Months

Level of Adiponectin at 2 months

Time frame: 2 months

Arm	Measure	Value (MEAN)	Dispersion
Control	Adiponectin at 2 Months	11.3 ng/ml	Standard Deviation 4.9
Omega-3 DHA	Adiponectin at 2 Months	8.6 ng/ml	Standard Deviation 2.6

Comparison: Between-Group Comparisonp-value: 0.04491ANCOVA

Comparison: Within-group comparisons between the baseline and 2 month datap-value: <0.001Paired t-test

Secondary

Adiponectin at 6 Months

Level of Adiponectin at 6 months

Time frame: 6 months

Arm	Measure	Value (MEAN)	Dispersion
Control	Adiponectin at 6 Months	9.9 ng/ml	Standard Deviation 4.8
Omega-3 DHA	Adiponectin at 6 Months	7.9 ng/ml	Standard Deviation 3.4

Comparison: Between-Group Comparisonp-value: 0.24396ANCOVA

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.00162Paired t-test

Secondary

Body Mass Index at 6 Months

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

Time frame: 6 months

Arm	Measure	Value (MEAN)	Dispersion
Control	Body Mass Index at 6 Months	25.6 kg/m^2	Standard Deviation 1.8
Omega-3 DHA	Body Mass Index at 6 Months	26.2 kg/m^2	Standard Deviation 1.6

Comparison: Between-Group Comparisonp-value: 0.519ANCOVA

Comparison: Within-group comparisons between the baseline and 6 month datap-value: <0.001Paired t-test

Secondary

C-reactive Protein (CRP) at 2 Months

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

Time frame: 2 months

Arm	Measure	Value (MEAN)	Dispersion
Control	C-reactive Protein (CRP) at 2 Months	2.3 mg/dl	Standard Deviation 2.3
Omega-3 DHA	C-reactive Protein (CRP) at 2 Months	3.2 mg/dl	Standard Deviation 2.9

Comparison: Between-Group Comparisonp-value: 0.27444ANCOVA

Comparison: Within-group comparisons between the baseline and 2 month datap-value: <0.001Paired t-test

Secondary

C-reactive Protein (CRP) at 6 Months

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

Time frame: 6 months

Arm	Measure	Value (MEAN)	Dispersion
Control	C-reactive Protein (CRP) at 6 Months	1.9 mg/dl	Standard Deviation 1.4
Omega-3 DHA	C-reactive Protein (CRP) at 6 Months	2.1 mg/dl	Standard Deviation 1.2

Comparison: Between-Group Comparisonp-value: 0.28489ANCOVA

Comparison: Within-group comparisons between the baseline and 6 month datap-value: <0.001Paired t-test

p-value: <0.001Paired t-test

Secondary

Interleukin-6 at 2 Months

Level of Interleukin-6 at 2 months

Time frame: 2 months

Arm	Measure	Value (MEAN)	Dispersion
Control	Interleukin-6 at 2 Months	4.0 ng/ml	Standard Deviation 2.1
Omega-3 DHA	Interleukin-6 at 2 Months	4.3 ng/ml	Standard Deviation 1.5

Comparison: Between-Group Comparisonp-value: 0.40485ANCOVA

Comparison: Within-group comparisons between the baseline and 2 month datap-value: <0.001Paired t-test

Secondary

Interleukin-6 at 6 Months

Level of Interleukin-6 at 6 months

Time frame: 6 months

Arm	Measure	Value (MEAN)	Dispersion
Control	Interleukin-6 at 6 Months	6.3 ng/ml	Standard Deviation 2.7
Omega-3 DHA	Interleukin-6 at 6 Months	4.9 ng/ml	Standard Deviation 2

Comparison: Between-Group Comparisonp-value: 0.13911ANCOVA

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.05726Paired t-test

Secondary

Leptin at 2 Months

Level of Leptin at 2 months

Time frame: 2 months

Arm	Measure	Value (MEAN)	Dispersion
Control	Leptin at 2 Months	5.8 ng/ml	Standard Deviation 6
Omega-3 DHA	Leptin at 2 Months	8.5 ng/ml	Standard Deviation 7.1

Comparison: Between-Group Comparisonp-value: 0.28743ANCOVA

Comparison: Within-group comparisons between the baseline and 2 month datap-value: <0.001Paired t-test

Secondary

Leptin at 6 Months

Level of Leptin at 6 months

Time frame: 6 months

Arm	Measure	Value (MEAN)	Dispersion
Control	Leptin at 6 Months	10.2 ng/ml	Standard Deviation 5.7
Omega-3 DHA	Leptin at 6 Months	15.8 ng/ml	Standard Deviation 10.2

Comparison: Between-Group Comparisonp-value: 0.58561ANCOVA

Comparison: Within-group comparisons between the baseline and 6 month datap-value: <0.001Paired t-test

p-value: <0.001Paired t-test

Secondary

LTB4 at 2 Months

Level of LTB4 at 2 months

Time frame: 2 months

Arm	Measure	Value (MEAN)	Dispersion
Control	LTB4 at 2 Months	43.41 pg/ml	Standard Deviation 128.46
Omega-3 DHA	LTB4 at 2 Months	1.49 pg/ml	Standard Deviation 5.58

Comparison: Between-Group Comparisonp-value: 0.2333ANCOVA

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.4292Paired t-test

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.3356Paired t-test

Secondary

LTB4 at 6 Months

Level of LTB4 at 6 months

Time frame: 6 months

Arm	Measure	Value (MEAN)	Dispersion
Control	LTB4 at 6 Months	13.34 pg/ml	Standard Deviation 18.3
Omega-3 DHA	LTB4 at 6 Months	16.31 pg/ml	Standard Deviation 18.99

Comparison: Between-Group Comparisonp-value: 0.683ANCOVA

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.8625Paired t-test

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.0068Paired t-test

Secondary

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

Arm	Measure	Group	Value (NUMBER)
Control	Number of Participants With Adverse Events as a Measure of Safety and Tolerability	Blood and lymphatic system disorders (hypotension)	2 participants
Control	Number of Participants With Adverse Events as a Measure of Safety and Tolerability	Gastrointestinal disorders	7 participants
Control	Number of Participants With Adverse Events as a Measure of Safety and Tolerability	General disorders	2 participants
Control	Number of Participants With Adverse Events as a Measure of Safety and Tolerability	Musculoskeletal and connective tissue disorders	2 participants
Control	Number of Participants With Adverse Events as a Measure of Safety and Tolerability	Nervous system disorders (migraine, cephalea)	0 participants
Control	Number of Participants With Adverse Events as a Measure of Safety and Tolerability	Skin and subcutaneous tissue disorders (hair loss)	1 participants
Omega-3 DHA	Number of Participants With Adverse Events as a Measure of Safety and Tolerability	Nervous system disorders (migraine, cephalea)	2 participants
Omega-3 DHA	Number of Participants With Adverse Events as a Measure of Safety and Tolerability	Blood and lymphatic system disorders (hypotension)	0 participants
Omega-3 DHA	Number of Participants With Adverse Events as a Measure of Safety and Tolerability	Musculoskeletal and connective tissue disorders	1 participants
Omega-3 DHA	Number of Participants With Adverse Events as a Measure of Safety and Tolerability	Gastrointestinal disorders	7 participants
Omega-3 DHA	Number of Participants With Adverse Events as a Measure of Safety and Tolerability	Skin and subcutaneous tissue disorders (hair loss)	3 participants
Omega-3 DHA	Number of Participants With Adverse Events as a Measure of Safety and Tolerability	General disorders	6 participants

Comparison: Between-Group Comparisonp-value: 0.72828Fisher Exact

Secondary

PD1 at 2 Months

Level of PD1 at 2 months

Time frame: 2 months

Arm	Measure	Value (MEAN)	Dispersion
Control	PD1 at 2 Months	3.70 pg/ml	Standard Deviation 4.99
Omega-3 DHA	PD1 at 2 Months	6.06 pg/ml	Standard Deviation 5.69

Comparison: Between-Group Comparisonp-value: 0.2643ANCOVA

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.0761Paired t-test

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.1342Paired t-test

Secondary

PD1 at 6 Months

Level of PD1 at 6 months

Time frame: 6 months

Arm	Measure	Value (MEAN)	Dispersion
Control	PD1 at 6 Months	4.51 pg/ml	Standard Deviation 3.11
Omega-3 DHA	PD1 at 6 Months	6.31 pg/ml	Standard Deviation 3.03

Comparison: Between-Group Comparisonp-value: 0.141ANCOVA

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.3774Paired t-test

p-value: 0.1811Paired t-test

Secondary

PGE2 at 2 Months

Level of PGE2 at 2 months

Time frame: 2 months

Arm	Measure	Value (MEAN)	Dispersion
Control	PGE2 at 2 Months	16.58 pg/ml	Standard Deviation 36.39
Omega-3 DHA	PGE2 at 2 Months	5.58 pg/ml	Standard Deviation 10.77

Comparison: Between-Group Comparisonp-value: 0.2894ANCOVA

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.2128Paired t-test

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.0823Paired t-test

Secondary

PGE2 at 6 Months

Level of PGE2 at 6 months

Time frame: 6 months

Arm	Measure	Value (MEAN)	Dispersion
Control	PGE2 at 6 Months	28.73 pg/ml	Standard Deviation 57.82
Omega-3 DHA	PGE2 at 6 Months	13.31 pg/ml	Standard Deviation 15.46

Comparison: Between-Group Comparisonp-value: 0.345ANCOVA

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.1365Paired t-test

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.0073Paired t-test

Secondary

Proresolution Index

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

Time frame: 2 months

Arm	Measure	Value (MEAN)	Dispersion
Control	Proresolution Index	0.55 ratio	Standard Deviation 0.2
Omega-3 DHA	Proresolution Index	0.72 ratio	Standard Deviation 0.19

Comparison: Between-Group Comparisonp-value: 0.032ANCOVA

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.022Paired t-test

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.4563Paired t-test

Secondary

Resistin at 2 Months

Level of Resistin at 2 months

Time frame: 2 months

Arm	Measure	Value (MEAN)	Dispersion
Control	Resistin at 2 Months	4.7 ng/ml	Standard Deviation 2.5
Omega-3 DHA	Resistin at 2 Months	4.5 ng/ml	Standard Deviation 1.9

Comparison: Between-Group Comparisonp-value: 0.60214ANCOVA

Comparison: Within-group comparisons between the baseline and 2 month datap-value: <0.001Paired t-test

Secondary

Resistin at 6 Months

Level of Resistin at 6 months

Time frame: 6 months

Arm	Measure	Value (MEAN)	Dispersion
Control	Resistin at 6 Months	3.6 ng/ml	Standard Deviation 2.4
Omega-3 DHA	Resistin at 6 Months	3.4 ng/ml	Standard Deviation 1.6

Comparison: Between-Group Comparisonp-value: 0.66053ANCOVA

Comparison: Within-group comparisons between the baseline and 6 month datap-value: <0.001Paired t-test

Comparison: Within-group comparisons between the baseline and 6 month datap-value: <0.05Paired t-test

Secondary

RVD2 at 2 Months

Level of RVD2 at 2 motnhs

Time frame: 2 months

Arm	Measure	Value (MEAN)	Dispersion
Control	RVD2 at 2 Months	29.15 pg/ml	Standard Deviation 37.23
Omega-3 DHA	RVD2 at 2 Months	23.16 pg/ml	Standard Deviation 39.62

Comparison: Between-Group Comparisonp-value: 0.6896ANCOVA

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.098Paired t-test

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.3526Paired t-test

Secondary

RVD2 at 6 Months

Level of RVD2 at 6 months

Time frame: 6 months

Arm	Measure	Value (MEAN)	Dispersion
Control	RVD2 at 6 Months	31.08 pg/ml	Standard Deviation 33.48
Omega-3 DHA	RVD2 at 6 Months	31.73 pg/ml	Standard Deviation 44.41

Comparison: Between-Group Comparisonp-value: 0.9662ANCOVA

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.145Paired t-test

p-value: 0.3811Paired t-test

Secondary

Sum of Proinflammatory Mediators at 2 Months

sum of proinflammatory mediators at 2 months

Time frame: 2 months

Arm	Measure	Value (MEAN)	Dispersion
Control	Sum of Proinflammatory Mediators at 2 Months	7470.14 pg/ml	Standard Deviation 4105.76
Omega-3 DHA	Sum of Proinflammatory Mediators at 2 Months	5842.09 pg/ml	Standard Deviation 1944.08

Comparison: Between-Group Comparisonp-value: 0.1946ANCOVA

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.2337Paired t-test

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.9188Paired t-test

Secondary

Sum of Proresolving Mediators at 2 Months

sum of proresolving mediators at 2 months

Time frame: 2 months

Arm	Measure	Value (MEAN)	Dispersion
Control	Sum of Proresolving Mediators at 2 Months	3943.32 pg/ml	Standard Deviation 2545.83
Omega-3 DHA	Sum of Proresolving Mediators at 2 Months	4152.90 pg/ml	Standard Deviation 1545.52

Comparison: Between-Group Comparisonp-value: 0.7964ANCOVA

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.768Paired t-test

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.5669Paired t-test

Secondary

Tnf Alpha at 2 Months

Level of Tnf alpha at 2 months

Time frame: 2 months

Arm	Measure	Value (MEAN)	Dispersion
Control	Tnf Alpha at 2 Months	3.1 ng/ml	Standard Deviation 2.1
Omega-3 DHA	Tnf Alpha at 2 Months	3.3 ng/ml	Standard Deviation 1.8

Comparison: Between-Group Comparisonp-value: 0.82322ANCOVA

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.25908Paired t-test

Secondary

Tnf Alpha at 6 Months

Level of Tnf alpha at 6 months

Time frame: 6 months

Arm	Measure	Value (MEAN)	Dispersion
Control	Tnf Alpha at 6 Months	2.0 ng/ml	Standard Deviation 0.4
Omega-3 DHA	Tnf Alpha at 6 Months	2.0 ng/ml	Standard Deviation 0.3

Comparison: Between-Group Comparisonp-value: 0.76435ANCOVA

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.18876Paired t-test

Secondary

TXB2 at 2 Months

Level of TXB2 at 2 months

Time frame: 2 months

Arm	Measure	Value (MEAN)	Dispersion
Control	TXB2 at 2 Months	177.96 pg/ml	Standard Deviation 249.02
Omega-3 DHA	TXB2 at 2 Months	149.31 pg/ml	Standard Deviation 123.06

Comparison: Between-Group Comparisonp-value: 0.7047ANCOVA

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.4749Paired t-test

Comparison: Within-group comparisons between the baseline and 2 month datap-value: 0.6014Paired t-test

Secondary

TXB2 at 6 Months

Level of TXB2 at 6 months

Time frame: 6 months

Arm	Measure	Value (MEAN)	Dispersion
Control	TXB2 at 6 Months	132.57 pg/ml	Standard Deviation 76.49
Omega-3 DHA	TXB2 at 6 Months	148.01 pg/ml	Standard Deviation 71.79

Comparison: Between-Group Comparisonp-value: 0.5932ANCOVA

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.714Paired t-test

Comparison: Within-group comparisons between the baseline and 6 month datap-value: 0.5827Paired t-test

Secondary

Waist Circumference at 6 Months

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

Time frame: 6 months

Arm	Measure	Value (MEAN)	Dispersion
Control	Waist Circumference at 6 Months	87.3 cm	Standard Deviation 7.4
Omega-3 DHA	Waist Circumference at 6 Months	89.0 cm	Standard Deviation 5.2

Comparison: Between-Group Comparisonp-value: 0.24567ANCOVA

Comparison: Within-group comparisons between the baseline and 6 month datap-value: <0.001Paired t-test

Secondary

Weight at 6 Months

Weight at 6 months (end of the monitoring period)

Time frame: 6 months

Arm	Measure	Value (MEAN)	Dispersion
Control	Weight at 6 Months	71.8 kg	Standard Deviation 11.4
Omega-3 DHA	Weight at 6 Months	72.3 kg	Standard Deviation 7.1

Comparison: Between-Group Comparisonp-value: 0.71833ANCOVA

Comparison: Within-group comparisons between the baseline and 6 month datap-value: <0.001Paired t-test

Comparison: Within-group comparisons between the baseline and 6 month datap-value: <0.001Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

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

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Proresolution Index

Sum of Proinflammatory Mediators at 6 Months

Sum of Proresolving Mediators at 6 Months

12-HETE at 2 Months

12-HETE at 6 Months

14-HDOHE at 2 Months

14-HDOHE at 6 Months

15-HETE at 2 Months

15-HETE at 6 Months

17-HDOHE at 2 Months

17-HDOHE at 6 Months

4-HDOHE at 2 Months

4-HDOHE at 6 Months

5-HETE at 2 Months

5-HETE at 6 Months

7-HDOHE at 2 Months

7-HDOHE at 6 Months

7RMAR1 at 2 Months

7RMAR1 at 6 Months

7SMAR1 at 2 Months

7SMAR1 at 6 Months

8-HETE at 2 Months

8-HETE at 6 Months

Adiponectin at 2 Months

Adiponectin at 6 Months

Body Mass Index at 6 Months

C-reactive Protein (CRP) at 2 Months

C-reactive Protein (CRP) at 6 Months

Interleukin-6 at 2 Months

Interleukin-6 at 6 Months

Leptin at 2 Months

Leptin at 6 Months

LTB4 at 2 Months

LTB4 at 6 Months

Number of Participants With Adverse Events as a Measure of Safety and Tolerability

PD1 at 2 Months

PD1 at 6 Months

PGE2 at 2 Months

PGE2 at 6 Months

Proresolution Index

Resistin at 2 Months

Resistin at 6 Months

RVD2 at 2 Months

RVD2 at 6 Months

Sum of Proinflammatory Mediators at 2 Months

Sum of Proresolving Mediators at 2 Months

Tnf Alpha at 2 Months

Tnf Alpha at 6 Months

TXB2 at 2 Months

TXB2 at 6 Months

Waist Circumference at 6 Months

Weight at 6 Months