Research Support Unit. Río Hortega University Hospital
Valladolid, Spain
NCT Number: NCT01865448
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.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Valladolid, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients take daily 2 tablets of Docosahexaenoic Acid
Other names: Docosahexaenoic Acid, omega-3 fatty acid, PUFA
Patients in control group take daily 2 placebo capsule
Other names: placebo capsule
Time frame: 6 months
Proresolution index is the ratio of sum of proresolving mediators/sum of proinflammatory mediators
Time frame: 6 months
Sum of proresolving mediators at 6 months
Time frame: 6 months
Sum of proinflammatory mediators at 6 months
Time frame: 6 months
Weight at 6 months (end of the monitoring period)
Time frame: 6 months
Body mass index at 6 months (end of the monitoring period)
Time frame: 6 months
Waist circumference at 6 Months (end of the monitoring period)
Time frame: 2 months
Level of c-reactive protein (CRP) at 2 months
Time frame: 6 months
Level of c.reactive protein (CRP) at 6 months
Time frame: 2 months
Level of Adiponectin at 2 months
Time frame: 6 months
Level of Adiponectin at 6 months
Time frame: 2 months
Level of Tnf alpha at 2 months
Time frame: 6 months
Level of Tnf alpha at 6 months
Time frame: 2 months
Level of Interleukin-6 at 2 months
Time frame: 6 months
Level of Interleukin-6 at 6 months
Time frame: 2 months
Level of Resistin at 2 months
Time frame: 6 months
Level of Resistin at 6 months
Time frame: 2 months
Level of Leptin at 2 months
Time frame: 6 months
Level of Leptin at 6 months
Time frame: 2 months
Level of 15-HETE at 2 months
Time frame: 6 months
Level of 15-HETE at 6 months
Time frame: 2 month
Level 12-HETE at 2 months
Time frame: 6 months
Level of 12-HETE at 6 months
Time frame: 2 months
Level of 8-HETE at 2 months
Time frame: 6 months
Level of 8-HETE at 6 months
Time frame: 2 months
Level of 5-HETE at 2 months
Time frame: 6 months
Level of 5-HETE at 6 months
Time frame: 2 months
Level of TXB2 at 2 months
Time frame: 6 months
Level of TXB2 at 6 months
Time frame: 2 months
Level of PGE2 at 2 months
Time frame: 6 months
Level of PGE2 at 6 months
Time frame: 2 months
Level of LTB4 at 2 months
Time frame: 6 months
Level of LTB4 at 6 months
Time frame: 2 months
Level of 17-HDOHE at 2 months
Time frame: 6 months
Level of 17-HDOHE at 6 months
Time frame: 2 months
Level of 14-HDOHE at 2 months
Time frame: 6 months
Level of 14-HDOHE at 6 months
Time frame: 2 months
Level of 7-HDOHE at 2 months
Time frame: 6 months
Level of 7-HDOHE at 6 months
Time frame: 2 months
Level of 4-HDOHE at 2 months
Time frame: 6 months
Level of 4-HDOHE at 6 months
Time frame: 2 months
Level of RVD2 at 2 motnhs
Time frame: 6 months
Level of RVD2 at 6 months
Time frame: 2 months
Level of PD1 at 2 months
Time frame: 6 months
Level of PD1 at 6 months
Time frame: 2 months
Level of 7SMAR1 at 2 months
Time frame: 6 months
Level of 7SMAR1 at 6 months
Time frame: 2 months
Level of 7RMAR1 at 2 months
Time frame: 6 months
Level of 7RMAR1 at 6 months
Time frame: 2 months
sum of proinflammatory mediators at 2 months
Time frame: 2 months
sum of proresolving mediators at 2 months
Time frame: 2 months
Proresolution index is the ratio of sum of proresolving mediators/sum of proinflammatory mediators
Time frame: 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
Protein Supplies SL
Other
Study to Assess the Effects of DHA (Docosahexaenoic Acid) on Pro-resolving Anti-inflammatory Mediators in Obese Patients Undergoing Weight-loss Treatment
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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