Omega-3 Supplementation After Surgical Treatment of Obesity

Early Phase 1CompletedNCT06494566

Instituto de Cardiologia do Rio Grande do Sul150 enrolled

Overview

The study evaluates diet supplementation of Omega-3 fatty acids after surgical treatment of obesity in adults. Half participants will receive diet supplementation of Omega-3 fatty acids, while the other half will receive placebo.

Omega-3 fatty acids has been related to immunomodulation and antioxidant action. Diet supplementation of Omega-3 fatty acids after surgical treatment of obesity may help stabilize protein catabolism, reduce peroxidative damage, and improve lipid profile.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

150

Conditions

Obesity

Interventions

Omega-3DIETARY_SUPPLEMENT

Omega-3 capsule

Mineral OilDIETARY_SUPPLEMENT

Mineral Oil Capsule

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * BMI \> 30kg/m2 * Candidate to bariatric and metabolic surgery Exclusion Criteria: * Use of Omega-3 * Contraindication to bioimpedance analysis * Uso of steroids, non steroidal inflammatory drugs, immunomodulators or antibiotics * Refusal to participate

Locations (2)

Irmandade Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Instituto de Cardiologia

Porto Alegre, Rio Grande do Sul, Brazil

Outcomes

Primary Outcomes

Weight

Measurement with digital scale, patient standing, barefoot. kilograms (kg)

Time frame: Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.

Height

Height measurement, patient standing, barefoot. Unit of measurement: meters (m).

Time frame: Points of evaluation: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.

Secondary Outcomes

Manual Grip Strength

Best of three handgrip strength measurements, patient seated, arm supported. Unit of measurement: kilograms-force (kgf).

Time frame: Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.

6-Minute Walk Test

Walking with measurements of distance covered. Units of measurement: meters.

Time frame: Points of evaluation: first and last preoperative nutritional assessment, fifteen days and three months and medium after surgery.

Electrical Bioimpedance - Percentage of muscle mass

Electrical bioimpedance scale measurement. Unit of measurement: percentage (%).

Time frame: Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.

Electrical Bioimpedance - Body fat percentage

Electrical bioimpedance scale measurement. Unit of measurement: percentage (%).

Time frame: Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.

Data from ClinicalTrials.gov

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