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OpenTrials
Completed

NCT Number: NCT02113696

Intake of Omega 3 in 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?

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Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omega 3 intake, morbid obesity

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.

Placebo capsules

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Decrease of weight

    Time frame: 08 weeks

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

Sponsors and collaborators

Lead sponsor

Pontificia Universidade Católica do Rio Grande do Sul

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 15, 2014
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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