Intake of Omega 3 in Morbidly Obese Patients

July 4, 2014 updated by: Pontificia Universidade Católica do Rio Grande do Sul

The Effect of ω-3 Polyunsaturated Fatty Acids (Eicosapentaenoic Acid and Docosahexanoic Acid) on Morbidly Obese Patients

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Placebo group
Placebo Capsules
Dietary supplement: Placebo 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.
Experimental: Omega 3 intake
Omega 3 intake, morbid obesity
Dietary supplement: Omega 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease of inflammatory levels on blood
Time Frame: 08 weeks
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
08 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease of weight
Time Frame: 08 weeks
The weight will be measured before and after the intake of omega 3.
08 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidade Católica do Rio Grande do Sul

Investigators

  • Study Director: Claudio C Motin, orientador, Centro de Obesidade Mórbida da Pontificia Universidade Católica do RS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

March 27, 2014

First Submitted That Met QC Criteria

April 10, 2014

First Posted (Estimate)

April 15, 2014

Study Record Updates

Last Update Posted (Estimate)

July 8, 2014

Last Update Submitted That Met QC Criteria

July 4, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • primary

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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