Intake of Omega 3 in Morbidly Obese Patients

Morbid Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02113696
• Other study ID #: primary
• Status: Completed
• Phase: N/A
• First received: March 27, 2014
• Last updated: July 4, 2014
• Start date: May 2014
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Pontificia Universidade Católica do Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Dietary Supplement:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidade Católica do Rio Grande do Sul

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Decrease of weight	The weight will be measured before and after the intake of omega 3.	08 weeks	Yes