CClinicalTrials.gg
CompletedNCT02113696Updated Jul 8, 2014

Intake of Omega 3 in Morbidly Obese Patients

An interventional study of Omega 3 intake, morbid obesity and Placebo Capsules in Morbid Obesity, sponsored by Pontificia Universidade Católica do Rio Grande do Sul. Completed. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2014-07-08.

Sponsored by Pontificia Universidade Católica do Rio Grande do Sul · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

Ingestion of capsules of omega 3 EPA and DHA, with 1.8 g of EPA and 1.2 g DHA for morbidly obese patients, will improve the inflammatory status? C-reactive protein? Weight?

Read the detailed description

Intake of EPA and DHA for the management of morbid obesity in capsules

  • Reduction of inflammatory factors such as adipokines, glucose, C-reactive protein, cholesterol, weight, BMI. Will be 2 groups: cases and controls. The cases will intake of omega 3 capsules and placebo control.
02

Conditions studied

  • Morbid Obesity

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Keywords

  • morbid obesity
  • BMI at or above 4O kg/m2
  • ingestion of omega 3
  • inflammatory cytokines
  • biochemical factors
  • anthropometric factors
03

In context

Obesity, Morbid

922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.

This study's enrollment of 46 is below the median of 60 across 590 interventional studies indexed under Obesity, Morbid.

Browse Obesity, Morbid studies →

Lead sponsor

Pontificia Universidade Católica do Rio Grande do Sul is the lead sponsor of 22 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Men and women aged between 18-65 years,
  • BMI > 40 kg/m2 (or > 35 kg/m2 with comorbidities),
  • ambulatory, receiving an oral diet,
  • with a diagnosis of metabolic syndrome,
  • and who signed a Term of Free and Informed Consent.

Exclusion criteria

Exclusion Criteria:

  • Systemic inflammatory response syndrome,
  • coma or compromised organ,
  • fever or infection foci,
  • cancer with or without chemotherapy and radiotherapy,
  • radiotherapy, inflammatory diseases of the gastrointestinal tract,
  • transplant, trauma, surgery or hospital stay in the past 30 days
  • use of steroids or non-steroid anti-inflammatory or immunomodulators agents or antibiotics,
  • or those refusing to take part in the study.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Placebo group

    Placebo Capsules

    Dietary Supplement: Placebo Capsules

  • Experimental
    Omega 3 intake

    Omega 3 intake, morbid obesity

    Dietary Supplement: Omega 3 intake, morbid obesity

Interventions

  • Dietary supplementOmega 3 intake, morbid obesity

    Individuals of both sexes with ages between 18 and 65 years took 3g of omega 3, and 1.8g eicosapentaenoic acid (EPA) and 1.2g docosahexanoic acid (DHA) for 8 weeks.

  • Dietary supplementPlacebo Capsules

    They received gelatin (colorless) capsules. A nutritional evaluation was performed, a 24-h recordatory was applied to verify macro and micronutrients intake, biochemical evaluation before and after the intervention. Macro and micronutrients were calculated using the Avanutri 2.0 system. Clinical history was verified through a questionnaire previously filled out by a physician.

06

What researchers measure

Primary outcomes

  1. Decrease of inflammatory levels on blood

    expected from this study verify inflammatory factors such as adipokines, glucose, c reactive protein, lipid profile, triglycerides, and anthropometric data as visceral fat, weight, BMI, in both groups, control and intervention, to see the action of the capsules of omega 3.patient may withdraw any time from ingestion of capsules, and the same will be provided by the laboratory Vitamed, which is regularized with the supervisory bodies and food security of Brazil

    Time frame: 08 weeks

Secondary outcomes

  1. Decrease of weight

    The weight will be measured before and after the intake of omega 3.

    Time frame: 08 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02113696
Lead sponsor
Pontificia Universidade Católica do Rio Grande do Sul
Responsible party
Sponsor
First posted
Apr 15, 2014
Start date
May 2014
Primary completion
Jun 2014
Completion
Jul 2014
Last update
Jul 8, 2014

Study contacts

Claudio C Motin, orientador
study director · Centro de Obesidade Mórbida da Pontificia Universidade Católica do RS

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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