Intake of Omega 3 in Morbidly Obese Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Morbid Obesity

Intervention / Treatment
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* Dietary Supplement: Omega 3 intake, morbid obesity
* Dietary Supplement: Placebo Capsules


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo group<br>Placebo Capsules | Dietary Supplement: Placebo Capsules<br>* 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.<br>|
| Experimental: Omega 3 intake<br>Omega 3 intake, morbid obesity | Dietary Supplement: Omega 3 intake, morbid obesity<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 08 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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morbid obesity, BMI at or above 4O kg/m2, ingestion of omega 3, inflammatory cytokines, biochemical factors, anthropometric factors