Clinical trial NCT00502021: Use of Flaxseed(Alpha Linolenic Acid) Powder in Morbidly Obese Patients With Systemic Inflammation
Official title: Inflammatory Indicators and Arterial Stiffness in Patients With Severe Obesity. Response to Supplementation of Alpha Linolenic Acid
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Morbid Obesity
Atherosclerosis
Systemic Inflammation
Keywords: obesity
alpha linolenic acid
flaxseed
C-reactive protein
inflammation
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2007-07-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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)

Eligibility criteria: 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

Primary outcomes:
measure: Reduction in arterial stiffness/intima thickness
timeFrame: 12 weeks
Secondary outcomes:
measure: Improvement in inflammatory markers and serum lipids
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas-ICHC-9th Floor- Av. Eneias C. Aguiar 255
Study officials:
affiliation: Sao Paulo University Medical School
name: Joel Faintuch, MD,PhD
role: STUDY_CHAIR
affiliation: Hospital das Clinicas
name: Patricia C Marques, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.