Use of Flaxseed(Alpha Linolenic Acid) Powder in Morbidly Obese Patients With Systemic Inflammation

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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Inflammatory Indicators and Arterial Stiffness in Patients With Severe Obesity. Response to Supplementation of Alpha Linolenic Acid

Conditions
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Morbid Obesity, Atherosclerosis, Systemic Inflammation

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Alpha-linolenic acid/ALA
* Dietary Supplement: Alpha linolenic acid/ALA
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Supplement of flaxseed powder (60 g/day)during 12 weeks | Dietary Supplement: Alpha-linolenic acid/ALA<br>* Flaxseed powder 60 g/day (10 g ALA)<br>* Other names: Linseed powder, omega- 3 fatty acid;|
| Placebo Comparator: 2<br>Placebo powder supplement 60 g/day during 12 weeks | Dietary Supplement: Placebo<br>* Manioc powder (placebo) 60 g/day<br>* Other names: Cassava powder;|
| Experimental: 3<br>Flaxseed oil 30 ml/day (10 g ALA)during 12 weeks | Dietary Supplement: Alpha linolenic acid/ALA<br>* Flaxseed oil 30 ml/day (10 g ALA)<br>* Other names: Linseed oil, omega- 3 fatty acid;|
| Placebo Comparator: 4<br>Safflower oil 30 ml/day (no ALA) during 12 weeks | Dietary Supplement: Placebo<br>* Safflower oil 30 ml/day<br>* Other names: Omega 6 fatty acids;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in arterial stiffness/intima thickness |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in inflammatory markers and serum lipids |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, alpha linolenic acid, flaxseed, C-reactive protein, inflammation