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ObesityNCT01865448

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

A study testing Omega-3 DHA in people with Obesity and Inflammation, run by Protein Supplies SL at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Obesity, Inflammation
What is being tested?
Omega-3 DHA
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
1 siteSpain
Study dates
May 2013to Mar 2015
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Research Support Unit. Río Hortega University Hospital

    Valladolid

Other trials in Spain

About this study

Official title: Study to Assess the Effects of DHA (Docosahexaenoic Acid) 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.

Read the 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.

Being tested
Omega-3 DHA, Placebo
Keywords
Docosahexaenoic Acids, Fatty Acids, Omega-3, Obesity, Inflammation
Medical subject headings
Obesity, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omega-3 DHADietary supplement

    Also called Docosahexaenoic Acid, omega-3 fatty acid, PUFA

    Patients take daily 2 tablets of Docosahexaenoic Acid

  • PlaceboOther

    Also called placebo capsule

    Patients in control group take daily 2 placebo capsule

Study groups in NCT01865448
Study groupRoleWhat they receive
omega-3 DHAActive comparatorPatients 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.
Receives: Dietary Supplement: Omega-3 DHA
ControlPlacebo comparatorPatients 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
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proresolution Index

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

    Measured: 6 months

  2. Sum of Proresolving Mediators at 6 Months

    Sum of proresolving mediators at 6 months

    Measured: 6 months

  3. Sum of Proinflammatory Mediators at 6 Months

    Sum of proinflammatory mediators at 6 months

    Measured: 6 months

Secondary outcomes (49)

  1. Weight at 6 Months

    Weight at 6 months (end of the monitoring period)

    Measured: 6 months

  2. Body Mass Index at 6 Months

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

    Measured: 6 months

  3. Waist Circumference at 6 Months

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

    Measured: 6 months

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

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

    Measured: 2 months

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

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

    Measured: 6 months

  6. Adiponectin at 2 Months

    Level of Adiponectin at 2 months

    Measured: 2 months

  7. Adiponectin at 6 Months

    Level of Adiponectin at 6 months

    Measured: 6 months

  8. Tnf Alpha at 2 Months

    Level of Tnf alpha at 2 months

    Measured: 2 months

  9. Tnf Alpha at 6 Months

    Level of Tnf alpha at 6 months

    Measured: 6 months

  10. Interleukin-6 at 2 Months

    Level of Interleukin-6 at 2 months

    Measured: 2 months

  11. Interleukin-6 at 6 Months

    Level of Interleukin-6 at 6 months

    Measured: 6 months

  12. Resistin at 2 Months

    Level of Resistin at 2 months

    Measured: 2 months

  13. Resistin at 6 Months

    Level of Resistin at 6 months

    Measured: 6 months

  14. Leptin at 2 Months

    Level of Leptin at 2 months

    Measured: 2 months

  15. Leptin at 6 Months

    Level of Leptin at 6 months

    Measured: 6 months

  16. 15-HETE at 2 Months

    Level of 15-HETE at 2 months

    Measured: 2 months

  17. 15-HETE at 6 Months

    Level of 15-HETE at 6 months

    Measured: 6 months

  18. 12-HETE at 2 Months

    Level 12-HETE at 2 months

    Measured: 2 month

  19. 12-HETE at 6 Months

    Level of 12-HETE at 6 months

    Measured: 6 months

  20. 8-HETE at 2 Months

    Level of 8-HETE at 2 months

    Measured: 2 months

  21. 8-HETE at 6 Months

    Level of 8-HETE at 6 months

    Measured: 6 months

  22. 5-HETE at 2 Months

    Level of 5-HETE at 2 months

    Measured: 2 months

  23. 5-HETE at 6 Months

    Level of 5-HETE at 6 months

    Measured: 6 months

  24. TXB2 at 2 Months

    Level of TXB2 at 2 months

    Measured: 2 months

  25. TXB2 at 6 Months

    Level of TXB2 at 6 months

    Measured: 6 months

  26. PGE2 at 2 Months

    Level of PGE2 at 2 months

    Measured: 2 months

  27. PGE2 at 6 Months

    Level of PGE2 at 6 months

    Measured: 6 months

  28. LTB4 at 2 Months

    Level of LTB4 at 2 months

    Measured: 2 months

  29. LTB4 at 6 Months

    Level of LTB4 at 6 months

    Measured: 6 months

  30. 17-HDOHE at 2 Months

    Level of 17-HDOHE at 2 months

    Measured: 2 months

  31. 17-HDOHE at 6 Months

    Level of 17-HDOHE at 6 months

    Measured: 6 months

  32. 14-HDOHE at 2 Months

    Level of 14-HDOHE at 2 months

    Measured: 2 months

  33. 14-HDOHE at 6 Months

    Level of 14-HDOHE at 6 months

    Measured: 6 months

  34. 7-HDOHE at 2 Months

    Level of 7-HDOHE at 2 months

    Measured: 2 months

  35. 7-HDOHE at 6 Months

    Level of 7-HDOHE at 6 months

    Measured: 6 months

  36. 4-HDOHE at 2 Months

    Level of 4-HDOHE at 2 months

    Measured: 2 months

  37. 4-HDOHE at 6 Months

    Level of 4-HDOHE at 6 months

    Measured: 6 months

  38. RVD2 at 2 Months

    Level of RVD2 at 2 motnhs

    Measured: 2 months

  39. RVD2 at 6 Months

    Level of RVD2 at 6 months

    Measured: 6 months

  40. PD1 at 2 Months

    Level of PD1 at 2 months

    Measured: 2 months

  41. PD1 at 6 Months

    Level of PD1 at 6 months

    Measured: 6 months

  42. 7SMAR1 at 2 Months

    Level of 7SMAR1 at 2 months

    Measured: 2 months

  43. 7SMAR1 at 6 Months

    Level of 7SMAR1 at 6 months

    Measured: 6 months

  44. 7RMAR1 at 2 Months

    Level of 7RMAR1 at 2 months

    Measured: 2 months

  45. 7RMAR1 at 6 Months

    Level of 7RMAR1 at 6 months

    Measured: 6 months

  46. Sum of Proinflammatory Mediators at 2 Months

    sum of proinflammatory mediators at 2 months

    Measured: 2 months

  47. Sum of Proresolving Mediators at 2 Months

    sum of proresolving mediators at 2 months

    Measured: 2 months

  48. Proresolution Index

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

    Measured: 2 months

  49. 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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionDec 2014
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01865448
Sponsor's protocol ID
PNK-DHA-2013-01
Status last verified
Mar 2019
First submitted
27 May 2013
Last updated
20 Jun 2019
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Omega-3 DHA in people with Obesity and Inflammation, run by Protein Supplies SL at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proresolution Index (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01865448.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2019.

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