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

Atherosclerosis Clinical Trial

Official title:

Inflammatory Indicators and Arterial Stiffness in Patients With Severe Obesity. Response to Supplementation of Alpha Linolenic Acid

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00502021
• Other study ID #: Flaxseed01
• Status: Recruiting
• Phase: Phase 2
• First received: July 16, 2007
• Last updated: September 27, 2012
• Start date: August 2007
• Est. completion date: October 2013

Study information

• Verified date: September 2012
• Source: University of Sao Paulo
• Contact: Joel Faintuch
• Phone: 5511- 330697561
• Email: jfaintuch[@]hcnet.usp.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Inflammation
• Morbid Obesity
• Obesity, Morbid
• Systemic Inflammation

Intervention

Dietary Supplement:
• Placebo
Manioc powder (placebo) 60 g/day
• Alpha-linolenic acid/ALA
Flaxseed powder 60 g/day (10 g ALA)
• Alpha linolenic acid/ALA
Flaxseed oil 30 ml/day (10 g ALA)
• Placebo
Safflower oil 30 ml/day

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas-ICHC-9th Floor- Av. Eneias C. Aguiar 255	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in arterial stiffness/intima thickness		12 weeks	No
Secondary	Improvement in inflammatory markers and serum lipids		12 weeks	No