Atherosclerosis Clinical Trial
Official title:
Inflammatory Indicators and Arterial Stiffness in Patients With Severe Obesity. Response to Supplementation of Alpha Linolenic Acid
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)
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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