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

Sponsored by:	University of Sao Paulo
Information provided by:	University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00502021

Purpose

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

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Obesity

Drug Information available for: Docosahexaenoic acids Eicosapentaenoic acid

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:

Reduction in arterial stiffness/intima thickness [ Time Frame: 12 weeks ]

Secondary Outcome Measures:

Improvement in inflammatory markers and serum lipids [ Time Frame: 12 weeks ]

Estimated Enrollment:	60
Study Start Date:	August 2007
Estimated Study Completion Date:	November 2007

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 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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502021

Contacts

Contact: Joel Faintuch	5511- 330697561 ext 18	jfaintuch@hcnet.usp.br
Contact: Patricia C Marques	5511-30697561 ext 18	patipaticamar@hotmail.com

Locations

Brazil
Hospital das Clinicas-ICHC-9th Floor- Av. Eneias C. Aguiar 255
Sao Paulo, Brazil, 05403-900

Sponsors and Collaborators

University of Sao Paulo

Investigators

Study Chair:	Joel Faintuch, MD,PhD	Sao Paulo University Medical School
Principal Investigator:	Patricia C Marques, MD	Hospital das Clinicas

More Information

Publications:

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.

Faintuch J, Horie LM, Schmidt VD, Barbeiro HV, Barbeiro DF, Soriano FG, Cecconello I. Obesity, inflammation, vascular reactivity, and cardiocirculatory events. Clinics. 2007 Jun;62(3):357-8. No abstract available.

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

Keywords provided by University of Sao Paulo:

obesity
alpha linolenic acid
flaxseed
C-reactive protein
inflammation

Study placed in the following topic categories:

Atherosclerosis
Arterial Occlusive Diseases
Obesity
Vascular Diseases
Obesity, Morbid
Overweight
Arteriosclerosis

Inflammation
Body Weight
Signs and Symptoms
Flax
Omega 3 Fatty Acid
Nutrition Disorders
Overnutrition

Additional relevant MeSH terms:

Atherosclerosis
Arterial Occlusive Diseases
Obesity
Vascular Diseases
Obesity, Morbid
Overweight
Arteriosclerosis

Inflammation
Body Weight
Signs and Symptoms
Pathologic Processes
Nutrition Disorders
Cardiovascular Diseases
Overnutrition

ClinicalTrials.gov processed this record on September 11, 2009