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Sponsored by: |
University of Sao Paulo |
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Information provided by: | University of Sao Paulo |
ClinicalTrials.gov Identifier: | NCT00502021 |
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.
Condition | Intervention | Phase |
---|---|---|
Morbid Obesity Atherosclerosis Systemic Inflammation |
Drug: Flaxseed powder supplementation(alpha linolenic acid) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Inflammatory Indicators and Arterial Stiffness in Patients With Severe Obesity. Response to Supplementation of Alpha Linolenic Acid |
Estimated Enrollment: | 60 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | November 2007 |
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 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)
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Joel Faintuch | 5511- 330697561 ext 18 | jfaintuch@hcnet.usp.br |
Contact: Patricia C Marques | 5511-30697561 ext 18 | patipaticamar@hotmail.com |
Brazil | |
Hospital das Clinicas-ICHC-9th Floor- Av. Eneias C. Aguiar 255 | |
Sao Paulo, Brazil, 05403-900 |
Study Chair: | Joel Faintuch, MD,PhD | Sao Paulo University Medical School |
Principal Investigator: | Patricia C Marques, MD | Hospital das Clinicas |
Study ID Numbers: | Flaxseed01 |
Study First Received: | July 16, 2007 |
Last Updated: | July 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00502021 History of Changes |
Health Authority: | Brazil:National Committee of Research/CONEP, Ministry of Health |
obesity alpha linolenic acid flaxseed C-reactive protein inflammation |
Body Weight Arterial Occlusive Diseases Atherosclerosis Signs and Symptoms Obesity Vascular Diseases |
Nutrition Disorders Overweight Overnutrition Obesity, Morbid Arteriosclerosis Inflammation |
Atherosclerosis Arterial Occlusive Diseases Obesity Vascular Diseases Obesity, Morbid Overweight Arteriosclerosis |
Inflammation Body Weight Signs and Symptoms Pathologic Processes Nutrition Disorders Cardiovascular Diseases Overnutrition |