Omega-3 Supplementation After Surgical Treatment of Obesity

Early Phase 1

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Mineral Oil; Dietary Supplement: Omega-3

• Registration Number: NCT06494566
• Lead Sponsor: Instituto de Cardiologia do Rio Grande do Sul

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2019-04-10
• Study First Submitted: 2019-07-22
• Primary Completion: 2023-07-30
• Study Completion: 2023-12-04
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-02
• Last Update Submitted: 2024-07-02
• Study First Posted: 2024-07-10
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Mineral Oil	Mineral oil capsule by mouth once a day for 90 days, starting on day sixteen after surgery.
Omega-3	Omega-3	Omega-3 2000mg (940mg of EPA and 660mg of DHA) in gastro resistant capsule by mouth once a day for 90 days, starting on day sixteen after surgery.

Primary Outcome Measures

Name	Time	Method
Height	Points of evaluation: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.	Height measurement, patient standing, barefoot. Unit of measurement: meters (m).
Weight	Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.	Measurement with digital scale, patient standing, barefoot. kilograms (kg)

Secondary Outcome Measures

Name	Time	Method
Electrical Bioimpedance - Percentage of muscle mass	Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.	Electrical bioimpedance scale measurement. Unit of measurement: percentage (%).
Electrical Bioimpedance - Body fat percentage	Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.	Electrical bioimpedance scale measurement. Unit of measurement: percentage (%).
Manual Grip Strength	Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery.	Best of three handgrip strength measurements, patient seated, arm supported. Unit of measurement: kilograms-force (kgf).
6-Minute Walk Test	Points of evaluation: first and last preoperative nutritional assessment, fifteen days and three months and medium after surgery.	Walking with measurements of distance covered. Units of measurement: meters.

Trial Locations

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