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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega-3 | Active Comparator | 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 | Mineral oil capsule by mouth once a day for 90 days, starting on day sixteen after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 | Dietary Supplement | Omega-3 capsule |
| |
| Mineral Oil |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Measurement with digital scale, patient standing, barefoot. kilograms (kg) | 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). | Points of evaluation: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Manual Grip Strength | Best of three handgrip strength measurements, patient seated, arm supported. Unit of measurement: kilograms-force (kgf). | Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery. |
| 6-Minute Walk Test |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irmandade Santa Casa de Misericórdia de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-072 | Brazil | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42289186 | Derived | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D008899 | Mineral Oil |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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Randomized, Double-blind, Placebo-controlled, Multicenter, CONSORT oriented study
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Participants will be randomized in blocks of two participants, at a 1:1 ratio, for the two groups of treatment. For every two participants, there will be one block. The number of each block will be hold in a nontransparent, seriated, sealed envelope. Intervention capsules will be opaque and stored in identical containers by a single investigator, who will not take part in data collection or analysis.
| Dietary Supplement |
Mineral Oil Capsule |
|
Walking with measurements of distance covered. Units of measurement: meters. |
| 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 (%). | 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 (%). | Assessment points: first and last preoperative nutritional assessment, fifteen days and three and a half months after surgery. |
| Instituto de Cardiologia |
| Porto Alegre |
| Rio Grande do Sul |
| 90040-371 |
| Brazil |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D010577 | Petrolatum |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |