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Preliminary studies have shown that flaxseed powder, rich in the omega-3 alpha-linolenic acid,is beneficial for the general inflammation present in morbidly obese subjects by decreasing elevated serum markers.As omega-3 fatty acids display additional properties including possible amelioration of atherosclerosis,a 3-month supplementation protocol was devised.Arterial stiffness and intima thickness will be measured in severely obese subjects, in order to document possible reduction of these variables as well.
Population:Morbidly obese non-smoking patients of the Department of Gastroenterology, candidates for possible bariatric treatment Criteria for inclusion: Males and females, 18- 65 years old, body mass index/BMI > 40 kg/m2 (or > 35 kg/m2 with comorbidities), non-hospitalized and receiving general oral diet, with elevated C-reactive protein/ CRP (> 5mg/L), and signing informed consent; Criteria for exclusion: SIRS, shock, coma or organ failure, fever or infectious foci, cancer with or without chemo/radiotherapy, inflammatory illnesses (rhematic, gastrointestinal or other), transplantation or immunologic diseases, trauma, surgery or hospitalization in the last 30 days, use of steroidal or non-steroidal anti-inflammatory or immune-modulating agents or antibiotics, and refusal to participate in the study; Dietetic routine: Daily flaxseed powder (Farinha de linhaca dourada) 60 g/day (232 kcal , containing 10 g of alpha-linolenic acid/ALA) or placebo (commercial manioc flour 60 g/day, 120 kcal)) during 12 weeks. An additional 60 subjects (30 patients, 30 controls) will ve managed with 30 ml/day flaxseed oil (10 g of alpha-linolenic acid/ALA) or 30 ml/day placebo (safflower oil).
Methods: Clinical questionnaire,nutritional assessment(Weight, height, BMI) Biochemical tests: Hemoglobin (HB) , white blood cell count (WBC), total cholesterol (CHOL) and fractions (HDL, LDL, VLDL), triglycerides (TRIG), blood glucose (GLU), serum albumin (ALB),insulin (INS), leptin (LEP),C-reactive protein (CRP), serum amyloid A (SAA), complement fractions C3 and C4, coagulation profile Atherosclerosis markers: Arterial stiffness (aorta) and intima thickness (common carotid artery)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Supplement of flaxseed powder (60 g/day)during 12 weeks |
|
| 2 | Placebo Comparator | Placebo powder supplement 60 g/day during 12 weeks |
|
| 3 | Experimental | Flaxseed oil 30 ml/day (10 g ALA)during 12 weeks |
|
| 4 | Placebo Comparator | Safflower oil 30 ml/day (no ALA) during 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Manioc powder (placebo) 60 g/day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in arterial stiffness/intima thickness | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in inflammatory markers and serum lipids | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joel Faintuch | Contact | 5511- 330697561 | 18 | jfaintuch@hcnet.usp.br |
| Patricia C Marques | Contact | 5511-30697561 | 18 | patipaticamar@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Joel Faintuch, MD,PhD | Sao Paulo University Medical School | Study Chair |
| Patricia C Marques, MD | Hospital das Clinicas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clinicas-ICHC-9th Floor- Av. Eneias C. Aguiar 255 | Recruiting | São Paulo | São Paulo | 05403-900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17546842 | Background | Faintuch J, Horie LM, Barbeiro HV, Barbeiro DF, Soriano FG, Ishida RK, Cecconello I. Systemic inflammation in morbidly obese subjects: response to oral supplementation with alpha-linolenic acid. Obes Surg. 2007 Mar;17(3):341-7. doi: 10.1007/s11695-007-9062-x. | |
| 17589679 | Background | Faintuch J, Horie LM, Schmidt VD, Barbeiro HV, Barbeiro DF, Soriano FG, Cecconello I. Obesity, inflammation, vascular reactivity, and cardiocirculatory events. Clinics (Sao Paulo). 2007 Jun;62(3):357-8. doi: 10.1590/s1807-59322007000300023. No abstract available. |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D050197 | Atherosclerosis |
| D009765 | Obesity |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D008043 | Linseed Oil |
| D043371 | Fatty Acids, Omega-6 |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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| Alpha-linolenic acid/ALA | Dietary Supplement | Flaxseed powder 60 g/day (10 g ALA) |
|
|
| Alpha linolenic acid/ALA | Dietary Supplement | Flaxseed oil 30 ml/day (10 g ALA) |
|
|
| Placebo | Dietary Supplement | Safflower oil 30 ml/day |
|
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |