Intake of Omega 3 in Morbidly Obese Patients

Not Applicable

Completed

• Conditions: Morbid Obesity
• Interventions: Dietary Supplement: Placebo Capsules; Dietary Supplement: Omega 3 intake, morbid obesity

• Registration Number: NCT02113696
• Lead Sponsor: Pontificia Universidade Católica do Rio Grande do Sul

Brief 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?

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 Timeline

• Study First Submitted: 2014-03-27
• Study First Submitted QC: 2014-04-10
• Study First Posted: 2014-04-15
• Study Start: 2014-05
• Primary Completion: 2014-06
• Status Verified: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-07-04
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo Capsules	Placebo Capsules
Omega 3 intake	Omega 3 intake, morbid obesity	Omega 3 intake, morbid obesity

Primary Outcome Measures

Name	Time	Method
Decrease of inflammatory levels on blood	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

Secondary Outcome Measures

Name	Time	Method
Decrease of weight	08 weeks	The weight will be measured before and after the intake of omega 3.