Intake of Omega 3 in Morbidly Obese Patients

NCT ID: NCT02113696

Last Updated: 2014-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-07-31

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.

Conditions

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Morbid Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Placebo group

Placebo Capsules

Group Type EXPERIMENTAL

Placebo Capsules

Intervention Type DIETARY_SUPPLEMENT

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.

Omega 3 intake

Omega 3 intake, morbid obesity

Group Type EXPERIMENTAL

Omega 3 intake, morbid obesity

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pontificia Universidade Católica do Rio Grande do Sul

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claudio C Motin, orientador

Role: STUDY_DIRECTOR

Centro de Obesidade Mórbida da Pontificia Universidade Católica do RS

Other Identifiers

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primary

Identifier Type: -

Identifier Source: org_study_id

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