Use of Flaxseed(Alpha Linolenic Acid) Powder in Morbidly Obese Patients With Systemic Inflammation
Inflammatory Indicators and Arterial Stiffness in Patients With Severe Obesity. Response to Supplementation of Alpha Linolenic Acid
Study Overview
Status
Conditions
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)
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Sao Paulo, Brazil, 05403-900
- Recruiting
- Hospital das Clinicas-ICHC-9th Floor- Av. Eneias C. Aguiar 255
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Contact:
- Patricia C Marques, MD
- Phone Number: 18 5511-30697561
- Email: patipaticamar@hotmail.com
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Principal Investigator:
- Ivan Cecconello, MD,PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: 1
Supplement of flaxseed powder (60 g/day)during 12 weeks
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Flaxseed powder 60 g/day (10 g ALA)
Other Names:
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PLACEBO_COMPARATOR: 2
Placebo powder supplement 60 g/day during 12 weeks
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Manioc powder (placebo) 60 g/day
Other Names:
Safflower oil 30 ml/day
Other Names:
|
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EXPERIMENTAL: 3
Flaxseed oil 30 ml/day (10 g ALA)during 12 weeks
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Flaxseed oil 30 ml/day (10 g ALA)
Other Names:
|
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PLACEBO_COMPARATOR: 4
Safflower oil 30 ml/day (no ALA) during 12 weeks
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Manioc powder (placebo) 60 g/day
Other Names:
Safflower oil 30 ml/day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Reduction in arterial stiffness/intima thickness
Time Frame: 12 weeks
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Improvement in inflammatory markers and serum lipids
Time Frame: 12 weeks
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12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Joel Faintuch, MD,PhD, Sao Paulo University Medical School
- Principal Investigator: Patricia C Marques, MD, Hospital das Clínicas
Publications and helpful links
General 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. doi: 10.1007/s11695-007-9062-x.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Flaxseed01
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