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

University of Sao Paulo

Status and phase: Unknown; Phase 2

Conditions: Systemic Inflammation; Morbid Obesity; Atherosclerosis

Treatments: Dietary Supplement: Alpha linolenic acid/ALA; Dietary Supplement: Placebo; Dietary Supplement: Alpha-linolenic acid/ALA

Study type: Interventional

Funder types: Other

Identifiers

NCT00502021

Flaxseed01

Details and patient eligibility

About

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.

Full 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)

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

Supplement of flaxseed powder (60 g/day)during 12 weeks

Treatment:

Dietary Supplement: Alpha-linolenic acid/ALA

2

Placebo Comparator group

Description:

Placebo powder supplement 60 g/day during 12 weeks

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Placebo

3

Experimental group

Description:

Flaxseed oil 30 ml/day (10 g ALA)during 12 weeks

Treatment:

Dietary Supplement: Alpha linolenic acid/ALA

4

Placebo Comparator group

Description:

Safflower oil 30 ml/day (no ALA) during 12 weeks

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Placebo