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NCT Number: NCT06494566

Omega-3 Supplementation After Surgical Treatment of Obesity

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.

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Key information

Conditions

Obesity Atrophy Body Weight Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Instituto de Cardiologia, Porto Alegre, Rio Grande do Sul, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3

Dietary Supplement

Omega-3 capsule

Mineral Oil

Dietary Supplement

Mineral Oil Capsule

Primary outcomes

  1. Weight

    Time frame: 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)

  2. Height

    Time frame: 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).

Secondary outcomes

  1. Manual Grip Strength

    Time frame: 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).

  2. 6-Minute Walk Test

    Time frame: 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.

  3. Electrical Bioimpedance - Percentage of muscle mass

    Time frame: 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 (%).

  4. Electrical Bioimpedance - Body fat percentage

    Time frame: 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 (%).

Sponsors and collaborators

Lead sponsor

Instituto de Cardiologia do Rio Grande do Sul

Other

Registry information

Official study title

Diet Supplementation of Omega-3 Fatty Acids After Surgical Treatment of Obesity: a Randomized Clinical Trial

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 10, 2024
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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