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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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00502021
Enrollment
90
Registered
2007-07-17
Start date
2007-08-31
Completion date
2013-10-31
Last updated
2012-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Morbid Obesity, Systemic Inflammation

Keywords

obesity, alpha linolenic acid, flaxseed, C-reactive protein, inflammation

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)

Interventions

DIETARY_SUPPLEMENTPlacebo

Manioc powder (placebo) 60 g/day

DIETARY_SUPPLEMENTAlpha-linolenic acid/ALA

Flaxseed powder 60 g/day (10 g ALA)

DIETARY_SUPPLEMENTAlpha linolenic acid/ALA

Flaxseed oil 30 ml/day (10 g ALA)

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Reduction in arterial stiffness/intima thickness12 weeks

Secondary

MeasureTime frame
Improvement in inflammatory markers and serum lipids12 weeks

Countries

Brazil

Contacts

Primary ContactJoel Faintuch
jfaintuch@hcnet.usp.br5511- 330697561
Backup ContactPatricia C Marques
patipaticamar@hotmail.com5511-30697561

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026