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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| omega-3 DHA | Active Comparator | 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. |
|
| Control | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 DHA | Dietary Supplement | Patients take daily 2 tablets of Docosahexaenoic Acid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proresolution Index | Proresolution index is the ratio of sum of proresolving mediators/sum of proinflammatory mediators | 6 months |
| Sum of Proresolving Mediators at 6 Months | Sum of proresolving mediators at 6 months | 6 months |
| Sum of Proinflammatory Mediators at 6 Months | Sum of proinflammatory mediators at 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Weight at 6 Months | Weight at 6 months (end of the monitoring period) | 6 months |
| Body Mass Index at 6 Months | Body mass index at 6 months (end of the monitoring period) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel De Luis, PhD | Unidad de Apoyo a la Investigacion. Hospital Rio Hortega | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Support Unit. RÃo Hortega University Hospital | Valladolid | Spain |
Not provided
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis with completers only
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Omega-3 DHA |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proresolution Index | Proresolution index is the ratio of sum of proresolving mediators/sum of proinflammatory mediators | Posted | Mean | Standard Deviation | ratio | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal Disorders | Gastrointestinal disorders | Systematic Assessment | Constipation, vomiting, diarrhea, stomachache, heartburn |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel de Luis | Unidad de Apoyo a la Investigacion. Hospital Rio Hortega | 983420400 | 83523 | dadluis@yahoo.es |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| Placebo | Other | Patients in control group take daily 2 placebo capsule |
|
|
| 6 months |
| Waist Circumference at 6 Months | Waist circumference at 6 Months (end of the monitoring period) | 6 months |
| C-reactive Protein (CRP) at 2 Months | Level of c-reactive protein (CRP) at 2 months | 2 months |
| C-reactive Protein (CRP) at 6 Months | Level of c.reactive protein (CRP) at 6 months | 6 months |
| Adiponectin at 2 Months | Level of Adiponectin at 2 months | 2 months |
| Adiponectin at 6 Months | Level of Adiponectin at 6 months | 6 months |
| Tnf Alpha at 2 Months | Level of Tnf alpha at 2 months | 2 months |
| Tnf Alpha at 6 Months | Level of Tnf alpha at 6 months | 6 months |
| Interleukin-6 at 2 Months | Level of Interleukin-6 at 2 months | 2 months |
| Interleukin-6 at 6 Months | Level of Interleukin-6 at 6 months | 6 months |
| Resistin at 2 Months | Level of Resistin at 2 months | 2 months |
| Resistin at 6 Months | Level of Resistin at 6 months | 6 months |
| Leptin at 2 Months | Level of Leptin at 2 months | 2 months |
| Leptin at 6 Months | Level of Leptin at 6 months | 6 months |
| 15-HETE at 2 Months | Level of 15-HETE at 2 months | 2 months |
| 15-HETE at 6 Months | Level of 15-HETE at 6 months | 6 months |
| 12-HETE at 2 Months | Level 12-HETE at 2 months | 2 month |
| 12-HETE at 6 Months | Level of 12-HETE at 6 months | 6 months |
| 8-HETE at 2 Months | Level of 8-HETE at 2 months | 2 months |
| 8-HETE at 6 Months | Level of 8-HETE at 6 months | 6 months |
| 5-HETE at 2 Months | Level of 5-HETE at 2 months | 2 months |
| 5-HETE at 6 Months | Level of 5-HETE at 6 months | 6 months |
| TXB2 at 2 Months | Level of TXB2 at 2 months | 2 months |
| TXB2 at 6 Months | Level of TXB2 at 6 months | 6 months |
| PGE2 at 2 Months | Level of PGE2 at 2 months | 2 months |
| PGE2 at 6 Months | Level of PGE2 at 6 months | 6 months |
| LTB4 at 2 Months | Level of LTB4 at 2 months | 2 months |
| LTB4 at 6 Months | Level of LTB4 at 6 months | 6 months |
| 17-HDOHE at 2 Months | Level of 17-HDOHE at 2 months | 2 months |
| 17-HDOHE at 6 Months | Level of 17-HDOHE at 6 months | 6 months |
| 14-HDOHE at 2 Months | Level of 14-HDOHE at 2 months | 2 months |
| 14-HDOHE at 6 Months | Level of 14-HDOHE at 6 months | 6 months |
| 7-HDOHE at 2 Months | Level of 7-HDOHE at 2 months | 2 months |
| 7-HDOHE at 6 Months | Level of 7-HDOHE at 6 months | 6 months |
| 4-HDOHE at 2 Months | Level of 4-HDOHE at 2 months | 2 months |
| 4-HDOHE at 6 Months | Level of 4-HDOHE at 6 months | 6 months |
| RVD2 at 2 Months | Level of RVD2 at 2 motnhs | 2 months |
| RVD2 at 6 Months | Level of RVD2 at 6 months | 6 months |
| PD1 at 2 Months | Level of PD1 at 2 months | 2 months |
| PD1 at 6 Months | Level of PD1 at 6 months | 6 months |
| 7SMAR1 at 2 Months | Level of 7SMAR1 at 2 months | 2 months |
| 7SMAR1 at 6 Months | Level of 7SMAR1 at 6 months | 6 months |
| 7RMAR1 at 2 Months | Level of 7RMAR1 at 2 months | 2 months |
| 7RMAR1 at 6 Months | Level of 7RMAR1 at 6 months | 6 months |
| Sum of Proinflammatory Mediators at 2 Months | sum of proinflammatory mediators at 2 months | 2 months |
| Sum of Proresolving Mediators at 2 Months | sum of proresolving mediators at 2 months | 2 months |
| Proresolution Index | Proresolution index is the ratio of sum of proresolving mediators/sum of proinflammatory mediators | 2 months |
| 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 | 6 months |
| dropout unrelated to study |
|
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight (Kg) | Mean | Standard Deviation | Kg |
|
| Body Mass Index (BMI) (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
|
| Waist circumference (cm) | Mean | Standard Deviation | cm |
|
| 15-HETE | Mean | Standard Deviation | pg/ml |
|
| 12 -HETE | Mean | Standard Deviation | pg/ml |
|
| 8-HETE | Mean | Standard Deviation | pg/ml |
|
| 5-HETE | Mean | Standard Deviation | pg/ml |
|
| TXB2 | Mean | Standard Deviation | pg/ml |
|
| PGE2 | Mean | Standard Deviation | pg/ml |
|
| LTB4 | Mean | Standard Deviation | pg/ml |
|
| 17-HDOHE | Mean | Standard Deviation | pg/ml |
|
| 14-HDOHE | Mean | Standard Deviation | pg/ml |
|
| 7-HDOHE | Mean | Standard Deviation | pg/ml |
|
| 4-HDOHE | Mean | Standard Deviation | pg/ml |
|
| RVD2 | Mean | Standard Deviation | pg/ml |
|
| PD1 | Mean | Standard Deviation | pg/ml |
|
| Sum of proinflammatory mediators | Sum of metabolite mediators derived from arachidonic acid (AA) | Mean | Standard Deviation | pg/ml |
|
| Sum of proresolving mediators | Sum of PUFA metabolite mediators derived from docosahexaenoic acid (DHA) | Mean | Standard Deviation | pg/ml |
|
| Proresolution index | Ratio of summation of proresolving mediators to summation of proinflammatory mediators | Mean | Standard Deviation | ratio |
|
| C-reactive Protein (CRP) (mg/dl) | Mean | Standard Deviation | mg/dl |
|
| Adiponectin (ng/ml) | Mean | Standard Deviation | ng/ml |
|
| Resistin (ng/ml) | Mean | Standard Deviation | ng/ml |
|
| Tnf alpha (ng/ml) | Mean | Standard Deviation | ng/ml |
|
| Interleukin-6 (ng/ml) | Mean | Standard Deviation | ng/ml |
|
| Leptin (ng/ml) | Mean | Standard Deviation | ng/ml |
|
| 7SMAR1 | Baseline 7SMAR1 was below limits of detection | Mean | Standard Deviation | pg/ml |
|
| 7RMAR1 | Baseline 7RMAR1 was below limits of detection | Mean | Standard Deviation | pg/ml |
|
|
|
|
| Secondary | Weight at 6 Months | Weight at 6 months (end of the monitoring period) | Posted | Mean | Standard Deviation | kg | 6 months |
|
|
|
|
| Secondary | Body Mass Index at 6 Months | Body mass index at 6 months (end of the monitoring period) | Posted | Mean | Standard Deviation | kg/m^2 | 6 months |
|
|
|
|
| Secondary | Waist Circumference at 6 Months | Waist circumference at 6 Months (end of the monitoring period) | Posted | Mean | Standard Deviation | cm | 6 months |
|
|
|
|
| Primary | Sum of Proresolving Mediators at 6 Months | Sum of proresolving mediators at 6 months | Posted | Mean | Standard Deviation | pg/ml | 6 months |
|
|
|
|
| Primary | Sum of Proinflammatory Mediators at 6 Months | Sum of proinflammatory mediators at 6 months | Posted | Mean | Standard Deviation | pg/ml | 6 months |
|
|
|
|
| Secondary | C-reactive Protein (CRP) at 2 Months | Level of c-reactive protein (CRP) at 2 months | Posted | Mean | Standard Deviation | mg/dl | 2 months |
|
|
|
|
| Secondary | C-reactive Protein (CRP) at 6 Months | Level of c.reactive protein (CRP) at 6 months | Posted | Mean | Standard Deviation | mg/dl | 6 months |
|
|
|
|
| Secondary | Adiponectin at 2 Months | Level of Adiponectin at 2 months | Posted | Mean | Standard Deviation | ng/ml | 2 months |
|
|
|
|
| Secondary | Adiponectin at 6 Months | Level of Adiponectin at 6 months | Posted | Mean | Standard Deviation | ng/ml | 6 months |
|
|
|
|
| Secondary | Tnf Alpha at 2 Months | Level of Tnf alpha at 2 months | Posted | Mean | Standard Deviation | ng/ml | 2 months |
|
|
|
|
| Secondary | Tnf Alpha at 6 Months | Level of Tnf alpha at 6 months | Posted | Mean | Standard Deviation | ng/ml | 6 months |
|
|
|
|
| Secondary | Interleukin-6 at 2 Months | Level of Interleukin-6 at 2 months | Posted | Mean | Standard Deviation | ng/ml | 2 months |
|
|
|
|
| Secondary | Interleukin-6 at 6 Months | Level of Interleukin-6 at 6 months | Posted | Mean | Standard Deviation | ng/ml | 6 months |
|
|
|
|
| Secondary | Resistin at 2 Months | Level of Resistin at 2 months | Posted | Mean | Standard Deviation | ng/ml | 2 months |
|
|
|
|
| Secondary | Resistin at 6 Months | Level of Resistin at 6 months | Posted | Mean | Standard Deviation | ng/ml | 6 months |
|
|
|
|
| Secondary | Leptin at 2 Months | Level of Leptin at 2 months | Posted | Mean | Standard Deviation | ng/ml | 2 months |
|
|
|
|
| Secondary | Leptin at 6 Months | Level of Leptin at 6 months | Posted | Mean | Standard Deviation | ng/ml | 6 months |
|
|
|
|
| Secondary | 15-HETE at 2 Months | Level of 15-HETE at 2 months | Posted | Mean | Standard Deviation | pg/ml | 2 months |
|
|
|
|
| Secondary | 15-HETE at 6 Months | Level of 15-HETE at 6 months | Posted | Mean | Standard Deviation | pg/ml | 6 months |
|
|
|
|
| Secondary | 12-HETE at 2 Months | Level 12-HETE at 2 months | Posted | Mean | Standard Deviation | pg/ml | 2 month |
|
|
|
|
| Secondary | 12-HETE at 6 Months | Level of 12-HETE at 6 months | Posted | Mean | Standard Deviation | pg/ml | 6 months |
|
|
|
|
| Secondary | 8-HETE at 2 Months | Level of 8-HETE at 2 months | Posted | Mean | Standard Deviation | pg/ml | 2 months |
|
|
|
|
| Secondary | 8-HETE at 6 Months | Level of 8-HETE at 6 months | Posted | Mean | Standard Deviation | pg/ml | 6 months |
|
|
|
|
| Secondary | 5-HETE at 2 Months | Level of 5-HETE at 2 months | Posted | Mean | Standard Deviation | pg/ml | 2 months |
|
|
|
|
| Secondary | 5-HETE at 6 Months | Level of 5-HETE at 6 months | Posted | Mean | Standard Deviation | pg/ml | 6 months |
|
|
|
|
| Secondary | TXB2 at 2 Months | Level of TXB2 at 2 months | Posted | Mean | Standard Deviation | pg/ml | 2 months |
|
|
|
|
| Secondary | TXB2 at 6 Months | Level of TXB2 at 6 months | Posted | Mean | Standard Deviation | pg/ml | 6 months |
|
|
|
|
| Secondary | PGE2 at 2 Months | Level of PGE2 at 2 months | Posted | Mean | Standard Deviation | pg/ml | 2 months |
|
|
|
|
| Secondary | PGE2 at 6 Months | Level of PGE2 at 6 months | Posted | Mean | Standard Deviation | pg/ml | 6 months |
|
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|
|
| Secondary | LTB4 at 2 Months | Level of LTB4 at 2 months | Posted | Mean | Standard Deviation | pg/ml | 2 months |
|
|
|
|
| Secondary | LTB4 at 6 Months | Level of LTB4 at 6 months | Posted | Mean | Standard Deviation | pg/ml | 6 months |
|
|
|
|
| Secondary | 17-HDOHE at 2 Months | Level of 17-HDOHE at 2 months | Posted | Mean | Standard Deviation | pg/ml | 2 months |
|
|
|
|
| Secondary | 17-HDOHE at 6 Months | Level of 17-HDOHE at 6 months | Posted | Mean | Standard Deviation | pg/ml | 6 months |
|
|
|
|
| Secondary | 14-HDOHE at 2 Months | Level of 14-HDOHE at 2 months | Posted | Mean | Standard Deviation | pg/ml | 2 months |
|
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|
|
| Secondary | 14-HDOHE at 6 Months | Level of 14-HDOHE at 6 months | Posted | Mean | Standard Deviation | pg/ml | 6 months |
|
|
|
|
| Secondary | 7-HDOHE at 2 Months | Level of 7-HDOHE at 2 months | Posted | Mean | Standard Deviation | pg/ml | 2 months |
|
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|
|
| Secondary | 7-HDOHE at 6 Months | Level of 7-HDOHE at 6 months | Posted | Mean | Standard Deviation | pg/ml | 6 months |
|
|
|
|
| Secondary | 4-HDOHE at 2 Months | Level of 4-HDOHE at 2 months | Posted | Mean | Standard Deviation | pg/ml | 2 months |
|
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|
|
| Secondary | 4-HDOHE at 6 Months | Level of 4-HDOHE at 6 months | Posted | Mean | Standard Deviation | pg/ml | 6 months |
|
|
|
|
| Secondary | RVD2 at 2 Months | Level of RVD2 at 2 motnhs | Posted | Mean | Standard Deviation | pg/ml | 2 months |
|
|
|
|
| Secondary | RVD2 at 6 Months | Level of RVD2 at 6 months | Posted | Mean | Standard Deviation | pg/ml | 6 months |
|
|
|
|
| Secondary | PD1 at 2 Months | Level of PD1 at 2 months | Posted | Mean | Standard Deviation | pg/ml | 2 months |
|
|
|
|
| Secondary | PD1 at 6 Months | Level of PD1 at 6 months | Posted | Mean | Standard Deviation | pg/ml | 6 months |
|
|
|
|
| Secondary | 7SMAR1 at 2 Months | Level of 7SMAR1 at 2 months | Posted | Mean | Standard Deviation | pg/ml | 2 months |
|
|
|
|
| Secondary | 7SMAR1 at 6 Months | Level of 7SMAR1 at 6 months | Posted | Mean | Standard Deviation | pg/ml | 6 months |
|
|
|
|
| Secondary | 7RMAR1 at 2 Months | Level of 7RMAR1 at 2 months | Posted | Mean | Standard Deviation | pg/ml | 2 months |
|
|
|
|
| Secondary | 7RMAR1 at 6 Months | Level of 7RMAR1 at 6 months | Posted | Mean | Standard Deviation | pg/ml | 6 months |
|
|
|
|
| Secondary | Sum of Proinflammatory Mediators at 2 Months | sum of proinflammatory mediators at 2 months | Posted | Mean | Standard Deviation | pg/ml | 2 months |
|
|
|
|
| Secondary | Sum of Proresolving Mediators at 2 Months | sum of proresolving mediators at 2 months | Posted | Mean | Standard Deviation | pg/ml | 2 months |
|
|
|
|
| Secondary | Proresolution Index | Proresolution index is the ratio of sum of proresolving mediators/sum of proinflammatory mediators | Posted | Mean | Standard Deviation | ratio | 2 months |
|
|
|
|
| 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 | Posted | Number | participants | 6 months |
|
|
|
|
| 0 |
| 17 |
| 9 |
| 17 |
| EG001 | 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 | 0 | 17 | 11 | 17 |
|
| Musculokeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment | Muscle pain, bone pain, muscular weakness |
|
| General Disorders | General disorders | Systematic Assessment | Halitosis, asthenia, heaviness, tiredness, cramps, hyperuricemia |
|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | Systematic Assessment | Hypotension |
|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | Systematic Assessment | Hair loss, urticaria |
|
| Nervous System disorders | Nervous system disorders | Systematic Assessment | Cephalea, migraine, headache effort |
|
Not provided
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| <0.001 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 6 month data | Wilcoxon (Mann-Whitney) | <0.001 | 2-Sided | Superiority or Other |
| <0.001 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 6 month data | Paired t-test | <0.001 | 2-Sided | Superiority or Other |
| <0.001 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 6 month data | Paired t-test | <0.001 | 2-Sided | Superiority or Other |
| 0.5257 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 6 month data | Paired t-test | 0.0657 | 2-Sided | Superiority or Other |
| 0.3745 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 6 month data | Paired t-test | 0.0476 | 2-Sided | Superiority or Other |
| <0.001 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 2 month data | Paired t-test | <0.001 | 2-Sided | Superiority or Other |
| <0.001 |
| 2-Sided |
| Superiority or Other |
| Paired t-test | <0.001 | 2-Sided | Superiority or Other |
| <0.001 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 2 month data | Paired t-test | <0.001 | 2-Sided | Superiority or Other |
| 0.00162 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 6 month data | Paired t-test | 0.00162 | 2-Sided | Superiority or Other |
| 0.25908 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 2 month data | Paired t-test | 0.25908 | 2-Sided | Superiority or Other |
| 0.18876 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 6 month data | Paired t-test | 0.18876 | 2-Sided | Superiority or Other |
| <0.001 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 2 month data | Paired t-test | <0.001 | 2-Sided | Superiority or Other |
| 0.05726 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 6 month data | Paired t-test | 0.05726 | 2-Sided | Superiority or Other |
| <0.001 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 2 month data | Paired t-test | <0.001 | 2-Sided | Superiority or Other |
| <0.001 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 6 month data | Paired t-test | <0.05 | 2-Sided | Superiority or Other |
| <0.001 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 2 month data | Paired t-test | <0.001 | 2-Sided | Superiority or Other |
| <0.001 |
| 2-Sided |
| Superiority or Other |
| Paired t-test | <0.001 | 2-Sided | Superiority or Other |
| 0.0351 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 2 month data | Paired t-test | 0.0795 | 2-Sided | Superiority or Other |
| 0.4310 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 6 month data | Paired t-test | 0.0049 | 2-Sided | Superiority or Other |
| 0.2755 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 2 month data | Paired t-test | 0.8226 | 2-Sided | Superiority or Other |
| 0.3761 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 6 month data | Paired t-test | 0.0281 | 2-Sided | Superiority or Other |
| 0.0404 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 2 month data | Paired t-test | 0.0474 | 2-Sided | Superiority or Other |
| 0.0482 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 6 month data | Paired t-test | 0.0394 | 2-Sided | Superiority or Other |
| 0.4421 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 2 month data | Paired t-test | 0.3198 | 2-Sided | Superiority or Other |
| 0.1034 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 6 month data | Paired t-test | 0.9898 | 2-Sided | Superiority or Other |
| 0.4749 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 2 month data | Paired t-test | 0.6014 | 2-Sided | Superiority or Other |
| 0.7140 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 6 month data | Paired t-test | 0.5827 | 2-Sided | Superiority or Other |
| 0.2128 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 2 month data | Paired t-test | 0.0823 | 2-Sided | Superiority or Other |
| 0.1365 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 6 month data | Paired t-test | 0.0073 | 2-Sided | Superiority or Other |
| 0.4292 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 2 month data | Paired t-test | 0.3356 | 2-Sided | Superiority or Other |
| 0.8625 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 6 month data | Paired t-test | 0.0068 | 2-Sided | Superiority or Other |
| 0.0291 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 2 month data | Paired t-test | 0.0402 | 2-Sided | Superiority or Other |
| 0.0472 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 6 month data | Paired t-test | 0.0197 | 2-Sided | Superiority or Other |
| 0.7218 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 2 month data | Paired t-test | 0.4536 | 2-Sided | Superiority or Other |
| 0.5114 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 6 month data | Paired t-test | 0.0237 | 2-Sided | Superiority or Other |
| 0.5594 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 2 month data | Paired t-test | 0.2532 | 2-Sided | Superiority or Other |
| 0.1920 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 6 month data | Paired t-test | 0.0011 | 2-Sided | Superiority or Other |
| 0.5184 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 2 month data | Paired t-test | 0.0564 | 2-Sided | Superiority or Other |
| 0.1263 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 6 month data | Paired t-test | 0.6484 | 2-Sided | Superiority or Other |
| 0.0980 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 2 month data | Paired t-test | 0.3526 | 2-Sided | Superiority or Other |
| 0.1450 |
| 2-Sided |
| Superiority or Other |
| Paired t-test | 0.3811 | 2-Sided | Superiority or Other |
| 0.0761 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 2 month data | Paired t-test | 0.1342 | 2-Sided | Superiority or Other |
| 0.3774 |
| Superiority or Other |
| Paired t-test | 0.1811 | 2-Sided | Superiority or Other |
| <0.0001 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 2 month data | Paired t-test | <0.0001 | 2-Sided | Superiority or Other |
| 0.0431 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 6 month data | Paired t-test | 0.0066 | 2-Sided | Superiority or Other |
| <0.0001 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 2 month data | Paired t-test | <0.0001 | 2-Sided | Superiority or Other |
| 0.0049 |
| 2-Sided |
| Superiority or Other |
| Paired t-test | 0.0062 | 2-Sided | Superiority or Other |
| 0.2337 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 2 month data | Paired t-test | 0.9188 | 2-Sided | Superiority or Other |
| 0.7680 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 2 month data | Paired t-test | 0.5669 | 2-Sided | Superiority or Other |
| 0.0220 |
| 2-Sided |
| Superiority or Other |
| Within-group comparisons between the baseline and 2 month data | Paired t-test | 0.4563 | 2-Sided | Superiority or Other |
| General disorders |
|
| Musculoskeletal and connective tissue disorders |
|
| Nervous system disorders (migraine, cephalea) |
|
| Skin and subcutaneous tissue disorders (hair loss) |
|