Use of Flaxseed(Alpha Linolenic Acid) Powder in Morbidly Obese Patients With Systemic Inflammation
Primary Purpose
Morbid Obesity, Atherosclerosis, Systemic Inflammation
Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Placebo
Alpha-linolenic acid/ALA
Alpha linolenic acid/ALA
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity focused on measuring obesity, alpha linolenic acid, flaxseed, C-reactive protein, inflammation
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
Sites / Locations
- Hospital das Clinicas-ICHC-9th Floor- Av. Eneias C. Aguiar 255Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
1
2
3
4
Arm Description
Supplement of flaxseed powder (60 g/day)during 12 weeks
Placebo powder supplement 60 g/day during 12 weeks
Flaxseed oil 30 ml/day (10 g ALA)during 12 weeks
Safflower oil 30 ml/day (no ALA) during 12 weeks
Outcomes
Primary Outcome Measures
Reduction in arterial stiffness/intima thickness
Secondary Outcome Measures
Improvement in inflammatory markers and serum lipids
Full Information
NCT ID
NCT00502021
First Posted
July 16, 2007
Last Updated
September 27, 2012
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00502021
Brief Title
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
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
October 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Atherosclerosis, Systemic Inflammation
Keywords
obesity, alpha linolenic acid, flaxseed, C-reactive protein, inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Supplement of flaxseed powder (60 g/day)during 12 weeks
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo powder supplement 60 g/day during 12 weeks
Arm Title
3
Arm Type
Experimental
Arm Description
Flaxseed oil 30 ml/day (10 g ALA)during 12 weeks
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Safflower oil 30 ml/day (no ALA) during 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Cassava powder
Intervention Description
Manioc powder (placebo) 60 g/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Alpha-linolenic acid/ALA
Other Intervention Name(s)
Linseed powder, omega- 3 fatty acid
Intervention Description
Flaxseed powder 60 g/day (10 g ALA)
Intervention Type
Dietary Supplement
Intervention Name(s)
Alpha linolenic acid/ALA
Other Intervention Name(s)
Linseed oil, omega- 3 fatty acid
Intervention Description
Flaxseed oil 30 ml/day (10 g ALA)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Omega 6 fatty acids
Intervention Description
Safflower oil 30 ml/day
Primary Outcome Measure Information:
Title
Reduction in arterial stiffness/intima thickness
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Improvement in inflammatory markers and serum lipids
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joel Faintuch
Phone
5511- 330697561
Ext
18
Email
jfaintuch@hcnet.usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia C Marques
Phone
5511-30697561
Ext
18
Email
patipaticamar@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Faintuch, MD,PhD
Organizational Affiliation
Sao Paulo University Medical School
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Patricia C Marques, MD
Organizational Affiliation
Hospital das Clinicas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clinicas-ICHC-9th Floor- Av. Eneias C. Aguiar 255
City
Sao Paulo
ZIP/Postal Code
05403-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia C Marques, MD
Phone
5511-30697561
Ext
18
Email
patipaticamar@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ivan Cecconello, MD,PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
17546842
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.
Results Reference
background
PubMed Identifier
17589679
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.
Results Reference
background
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Use of Flaxseed(Alpha Linolenic Acid) Powder in Morbidly Obese Patients With Systemic Inflammation
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