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Intake of Omega 3 in Morbidly Obese Patients

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Omega 3 intake, morbid obesity
Placebo Capsules
Sponsored by
Pontificia Universidade Católica do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Morbid Obesity focused on measuring morbid obesity, BMI at or above 4O kg/m2, ingestion of omega 3, inflammatory cytokines, biochemical factors, anthropometric factors

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Placebo group

    Omega 3 intake

    Arm Description

    Placebo Capsules

    Omega 3 intake, morbid obesity

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    March 27, 2014
    Last Updated
    July 4, 2014
    Sponsor
    Pontificia Universidade Católica do Rio Grande do Sul
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02113696
    Brief Title
    Intake of Omega 3 in Morbidly Obese Patients
    Official Title
    The Effect of ω-3 Polyunsaturated Fatty Acids (Eicosapentaenoic Acid and Docosahexanoic Acid) on Morbidly Obese Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2014 (undefined)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    July 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pontificia Universidade Católica do Rio Grande do Sul

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Morbid Obesity
    Keywords
    morbid obesity, BMI at or above 4O kg/m2, ingestion of omega 3, inflammatory cytokines, biochemical factors, anthropometric factors

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    46 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo group
    Arm Type
    Experimental
    Arm Description
    Placebo Capsules
    Arm Title
    Omega 3 intake
    Arm Type
    Experimental
    Arm Description
    Omega 3 intake, morbid obesity
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Omega 3 intake, morbid obesity
    Intervention Description
    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
    Intervention Name(s)
    Placebo Capsules
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Decrease of inflammatory levels on blood
    Description
    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 Outcome Measure Information:
    Title
    Decrease of weight
    Description
    The weight will be measured before and after the intake of omega 3.
    Time Frame
    08 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Claudio C Motin, orientador
    Organizational Affiliation
    Centro de Obesidade Mórbida da Pontificia Universidade Católica do RS
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Intake of Omega 3 in Morbidly Obese Patients

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