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Completed

NCT Number: NCT01865448

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

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Support Unit. Río Hortega University Hospital

Valladolid, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3 DHA

Dietary Supplement

Patients take daily 2 tablets of Docosahexaenoic Acid

Other names: Docosahexaenoic Acid, omega-3 fatty acid, PUFA

Placebo

Other

Patients in control group take daily 2 placebo capsule

Other names: placebo capsule

Primary outcomes

  1. Proresolution Index

    Time frame: 6 months

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

  2. Sum of Proresolving Mediators at 6 Months

    Time frame: 6 months

    Sum of proresolving mediators at 6 months

  3. Sum of Proinflammatory Mediators at 6 Months

    Time frame: 6 months

    Sum of proinflammatory mediators at 6 months

Secondary outcomes

  1. Weight at 6 Months

    Time frame: 6 months

    Weight at 6 months (end of the monitoring period)

  2. Body Mass Index at 6 Months

    Time frame: 6 months

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

  3. Waist Circumference at 6 Months

    Time frame: 6 months

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

  4. C-reactive Protein (CRP) at 2 Months

    Time frame: 2 months

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

  5. C-reactive Protein (CRP) at 6 Months

    Time frame: 6 months

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

  6. Adiponectin at 2 Months

    Time frame: 2 months

    Level of Adiponectin at 2 months

  7. Adiponectin at 6 Months

    Time frame: 6 months

    Level of Adiponectin at 6 months

  8. Tnf Alpha at 2 Months

    Time frame: 2 months

    Level of Tnf alpha at 2 months

  9. Tnf Alpha at 6 Months

    Time frame: 6 months

    Level of Tnf alpha at 6 months

  10. Interleukin-6 at 2 Months

    Time frame: 2 months

    Level of Interleukin-6 at 2 months

  11. Interleukin-6 at 6 Months

    Time frame: 6 months

    Level of Interleukin-6 at 6 months

  12. Resistin at 2 Months

    Time frame: 2 months

    Level of Resistin at 2 months

  13. Resistin at 6 Months

    Time frame: 6 months

    Level of Resistin at 6 months

  14. Leptin at 2 Months

    Time frame: 2 months

    Level of Leptin at 2 months

  15. Leptin at 6 Months

    Time frame: 6 months

    Level of Leptin at 6 months

  16. 15-HETE at 2 Months

    Time frame: 2 months

    Level of 15-HETE at 2 months

  17. 15-HETE at 6 Months

    Time frame: 6 months

    Level of 15-HETE at 6 months

  18. 12-HETE at 2 Months

    Time frame: 2 month

    Level 12-HETE at 2 months

  19. 12-HETE at 6 Months

    Time frame: 6 months

    Level of 12-HETE at 6 months

  20. 8-HETE at 2 Months

    Time frame: 2 months

    Level of 8-HETE at 2 months

  21. 8-HETE at 6 Months

    Time frame: 6 months

    Level of 8-HETE at 6 months

  22. 5-HETE at 2 Months

    Time frame: 2 months

    Level of 5-HETE at 2 months

  23. 5-HETE at 6 Months

    Time frame: 6 months

    Level of 5-HETE at 6 months

  24. TXB2 at 2 Months

    Time frame: 2 months

    Level of TXB2 at 2 months

  25. TXB2 at 6 Months

    Time frame: 6 months

    Level of TXB2 at 6 months

  26. PGE2 at 2 Months

    Time frame: 2 months

    Level of PGE2 at 2 months

  27. PGE2 at 6 Months

    Time frame: 6 months

    Level of PGE2 at 6 months

  28. LTB4 at 2 Months

    Time frame: 2 months

    Level of LTB4 at 2 months

  29. LTB4 at 6 Months

    Time frame: 6 months

    Level of LTB4 at 6 months

  30. 17-HDOHE at 2 Months

    Time frame: 2 months

    Level of 17-HDOHE at 2 months

  31. 17-HDOHE at 6 Months

    Time frame: 6 months

    Level of 17-HDOHE at 6 months

  32. 14-HDOHE at 2 Months

    Time frame: 2 months

    Level of 14-HDOHE at 2 months

  33. 14-HDOHE at 6 Months

    Time frame: 6 months

    Level of 14-HDOHE at 6 months

  34. 7-HDOHE at 2 Months

    Time frame: 2 months

    Level of 7-HDOHE at 2 months

  35. 7-HDOHE at 6 Months

    Time frame: 6 months

    Level of 7-HDOHE at 6 months

  36. 4-HDOHE at 2 Months

    Time frame: 2 months

    Level of 4-HDOHE at 2 months

  37. 4-HDOHE at 6 Months

    Time frame: 6 months

    Level of 4-HDOHE at 6 months

  38. RVD2 at 2 Months

    Time frame: 2 months

    Level of RVD2 at 2 motnhs

  39. RVD2 at 6 Months

    Time frame: 6 months

    Level of RVD2 at 6 months

  40. PD1 at 2 Months

    Time frame: 2 months

    Level of PD1 at 2 months

  41. PD1 at 6 Months

    Time frame: 6 months

    Level of PD1 at 6 months

  42. 7SMAR1 at 2 Months

    Time frame: 2 months

    Level of 7SMAR1 at 2 months

  43. 7SMAR1 at 6 Months

    Time frame: 6 months

    Level of 7SMAR1 at 6 months

  44. 7RMAR1 at 2 Months

    Time frame: 2 months

    Level of 7RMAR1 at 2 months

  45. 7RMAR1 at 6 Months

    Time frame: 6 months

    Level of 7RMAR1 at 6 months

  46. Sum of Proinflammatory Mediators at 2 Months

    Time frame: 2 months

    sum of proinflammatory mediators at 2 months

  47. Sum of Proresolving Mediators at 2 Months

    Time frame: 2 months

    sum of proresolving mediators at 2 months

  48. Proresolution Index

    Time frame: 2 months

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

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

    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

Sponsors and collaborators

Lead sponsor

Protein Supplies SL

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
May 30, 2013
Registry last updated
Jun 20, 2019

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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