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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Joel Faintuch, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00502021
First received: July 16, 2007
Last updated: September 27, 2012
Last verified: September 2012
  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
Dietary Supplement: Placebo
Dietary Supplement: Alpha-linolenic acid/ALA
Dietary Supplement: Alpha linolenic acid/ALA
Phase 2

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

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Reduction in arterial stiffness/intima thickness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in inflammatory markers and serum lipids [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: August 2007
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Supplement of flaxseed powder (60 g/day)during 12 weeks
Dietary Supplement: Alpha-linolenic acid/ALA
Flaxseed powder 60 g/day (10 g ALA)
Other Name: Linseed powder, omega- 3 fatty acid
Placebo Comparator: 2
Placebo powder supplement 60 g/day during 12 weeks
Dietary Supplement: Placebo
Manioc powder (placebo) 60 g/day
Other Name: Cassava powder
Experimental: 3
Flaxseed oil 30 ml/day (10 g ALA)during 12 weeks
Dietary Supplement: Alpha linolenic acid/ALA
Flaxseed oil 30 ml/day (10 g ALA)
Other Name: Linseed oil, omega- 3 fatty acid
Placebo Comparator: 4
Safflower oil 30 ml/day (no ALA) during 12 weeks
Dietary Supplement: Placebo
Safflower oil 30 ml/day
Other Name: Omega 6 fatty acids

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Recruiting
Sao Paulo, Brazil, 05403-900
Contact: Patricia C Marques, MD    5511-30697561 ext 18    patipaticamar@hotmail.com   
Principal Investigator: Ivan Cecconello, MD,PhD         
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:
Responsible Party: Joel Faintuch, Associate Professor, Department of Gastroenterology, Sao Paulo University Medical School, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00502021     History of Changes
Other Study ID Numbers: Flaxseed01
Study First Received: July 16, 2007
Last Updated: September 27, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
obesity
alpha linolenic acid
flaxseed
C-reactive protein
inflammation

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Inflammation
Obesity
Obesity, Morbid
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014