Omega-3 Supplementation After Surgical Treatment of Obesity

Instituto de Cardiologia do Rio Grande do Sul

Status and phase: Completed; Early Phase 1

Conditions: Obesity

Treatments: Dietary Supplement: Mineral Oil; Dietary Supplement: Omega-3

Study type: Interventional

Funder types: Other

Identifiers

NCT06494566

10311419.5.0000.5333

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Omega-3

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Omega-3

Placebo

Placebo Comparator group

Description:

Mineral oil capsule by mouth once a day for 90 days, starting on day sixteen after surgery.

Treatment:

Dietary Supplement: Mineral Oil