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

Phase 2

• Conditions: Morbid Obesity; Atherosclerosis; Systemic Inflammation
• Interventions: Dietary Supplement: Alpha-linolenic acid/ALA; Dietary Supplement: Placebo; Dietary Supplement: Alpha linolenic acid/ALA

• Registration Number: NCT00502021
• Lead Sponsor: University of Sao Paulo

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)

Study Timeline

• Study First Submitted: 2007-07-16
• Study First Submitted QC: 2007-07-16
• Study First Posted: 2007-07-17
• Study Start: 2007-08
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-27
• Last Update Posted: 2012-09-28
• Primary Completion: 2013-08
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Alpha-linolenic acid/ALA	Supplement of flaxseed powder (60 g/day)during 12 weeks
2	Placebo	Placebo powder supplement 60 g/day during 12 weeks
3	Alpha linolenic acid/ALA	Flaxseed oil 30 ml/day (10 g ALA)during 12 weeks
4	Placebo	Safflower oil 30 ml/day (no ALA) during 12 weeks

Primary Outcome Measures

Name	Time	Method
Reduction in arterial stiffness/intima thickness	12 weeks

Secondary Outcome Measures

Name	Time	Method
Improvement in inflammatory markers and serum lipids	12 weeks

Trial Locations

Locations (1)

Hospital das Clinicas-ICHC-9th Floor- Av. Eneias C. Aguiar 255; 🇧🇷 Sao Paulo, Brazil