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

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ClinicalTrials.gov Identifier: NCT01865448
Recruitment Status : Completed
First Posted : May 30, 2013
Results First Posted : June 20, 2019
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Protein Supplies SL

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.

Condition or disease Intervention/treatment Phase
Obesity Inflammation Dietary Supplement: Omega-3 DHA Other: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Study to Assess the Effects of DHA (Docosahexaenoic Acid) on Pro-resolving Anti-inflammatory Mediators in Obese Patients Undergoing Weight-loss Treatment
Study Start Date : May 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Dietary Supplement: Omega-3 DHA
Patients take daily 2 tablets of Docosahexaenoic Acid
Other Names:
  • Docosahexaenoic Acid
  • omega-3 fatty acid
  • PUFA

Placebo Comparator: Control
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
Other: Placebo
Patients in control group take daily 2 placebo capsule
Other Name: placebo capsule




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865448


Locations
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Spain
Research Support Unit. Río Hortega University Hospital
Valladolid, Spain
Sponsors and Collaborators
Protein Supplies SL
Investigators
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Principal Investigator: Daniel De Luis, PhD Unidad de Apoyo a la Investigacion. Hospital Rio Hortega

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Responsible Party: Protein Supplies SL
ClinicalTrials.gov Identifier: NCT01865448     History of Changes
Other Study ID Numbers: PNK-DHA-2013-01
First Posted: May 30, 2013    Key Record Dates
Results First Posted: June 20, 2019
Last Update Posted: June 20, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Protein Supplies SL:
Docosahexaenoic Acids
Fatty Acids, Omega-3
Obesity
Inflammation
Additional relevant MeSH terms:
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Inflammation
Weight Loss
Body Weight
Signs and Symptoms
Pathologic Processes
Body Weight Changes
Anti-Inflammatory Agents