Intake of Omega 3 in Morbidly Obese Patients

NCT02113696 | Completed DMC

• 1 other identifier: primary
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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?

Conditions

Morbid Obesity

Keywords

morbid obesity; BMI at or above 4O kg/m2; ingestion of omega 3; inflammatory cytokines; biochemical factors; anthropometric factors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Decrease of weight

  08 weeks

Study Arms (2)

Placebo group

EXPERIMENTAL

Placebo Capsules

Dietary Supplement: Placebo Capsules

Omega 3 intake

EXPERIMENTAL

Omega 3 intake, morbid obesity

Dietary Supplement: Omega 3 intake, morbid obesity

Interventions

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.

Omega 3 intake

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.

Placebo group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pontificia Universidade Católica do Rio Grande do Sul: lead

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Officials

• Claudio C Motin, orientador

  Centro de Obesidade Mórbida da Pontificia Universidade Católica do RS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: April 15, 2014
• Study Start: May 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 8, 2014

Record last verified: 2014-07