Diet Supplementation of Omega-3 Fatty Acids After Surgical Treatment of Obesity: a Randomized Clinical Trial
| Registry | NCT06494566 |
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| Status | Completed |
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| Phase | Early Phase 1 |
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| Study type | Interventional; randomized, parallel, masking: quadruple, prevention |
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| Enrollment | 150 (Actual) |
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| Sponsor | Instituto de Cardiologia do Rio Grande do Sul (Other) |
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| Conditions | Obesity |
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| Interventions | Omega-3, Mineral Oil (Dietary supplement) |
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| Dates | start 2019-04-10, primary completion 2023-07-30, completion 2023-12-04, first posted 2024-07-10, last updated 2024-07-10 |
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| Locations | 2 sites in Brazil |
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Related Papers Related Patents Related Grants Related Experts
All trials for Obesity All trials of Omega-3 All trials of Mineral Oil
-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.
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Omega-3 | Active comparator | Dietary Supplement: 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. |
| Placebo | Placebo comparator | Dietary Supplement: Mineral Oil | Mineral oil capsule by mouth once a day for 90 days, starting on day sixteen after surgery. |
- Omega-3 (Dietary supplement): Omega-3 capsule
- Mineral Oil (Dietary supplement): Mineral Oil Capsule
+Outcome measures
Primary outcomes
- 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)
- 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).
Secondary outcomes
- 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.
- 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 (%).
+Eligibility
Sex: All, ages: 18 Years to any
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)
| Facility | City | Country | Status |
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| 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 | |
+Publications
- Results publication: Bigolin AV, Iaroseski J, Carteri RB, Rodrigues GS, de Andrade R, De Carli LA, Razzera EL, Vian I, de Almeida da Silva R, Kalil AN, Ferreira LF. Effects of Omega-3 Supplementation in Sarcopenia After Bariatric Surgery: A Triple-Blind Randomized Controlled Clinical Trial. J Cachexia Sarcopenia Muscle. 2026 Jun;17(3):e70321. doi: 10.1002/jcsm.70321. PMID 42289186