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

NCT00502021 | Unknown Phase 2

• 1 other identifier: Flaxseed01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity; Atherosclerosis; Systemic Inflammation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Reduction in arterial stiffness/intima thickness

  12 weeks

Secondary Outcomes (1)

• Improvement in inflammatory markers and serum lipids

  12 weeks

Study Arms (4)

1

EXPERIMENTAL

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

Dietary Supplement: Alpha-linolenic acid/ALA

2

PLACEBO COMPARATOR

Placebo powder supplement 60 g/day during 12 weeks

Dietary Supplement: Placebo

3

EXPERIMENTAL

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

Dietary Supplement: Alpha linolenic acid/ALA

4

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

Manioc powder (placebo) 60 g/day

Also known as: Cassava powder

2

Alpha-linolenic acid/ALA DIETARY_SUPPLEMENT

Flaxseed powder 60 g/day (10 g ALA)

Also known as: Linseed powder, omega- 3 fatty acid

1

Alpha linolenic acid/ALA DIETARY_SUPPLEMENT

Flaxseed oil 30 ml/day (10 g ALA)

Also known as: Linseed oil, omega- 3 fatty acid

3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital das Clinicas-ICHC-9th Floor- Av. Eneias C. Aguiar 255

São Paulo, São Paulo, 05403-900, Brazil

RECRUITING

Related 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. doi: 10.1007/s11695-007-9062-x.

  PMID: 17546842 BACKGROUND

• 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.

  PMID: 17589679 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid; Atherosclerosis; Obesity; Inflammation

Interventions

Docosahexaenoic Acids; Linseed Oil; Fatty Acids, Omega-6

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Joel Faintuch, MD,PhD

  Sao Paulo University Medical School

  STUDY CHAIR

• Patricia C Marques, MD

  Hospital das Clinicas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joel Faintuch

CONTACT

5511- 330697561; jfaintuch@hcnet.usp.br

Patricia C Marques

CONTACT

5511-30697561; patipaticamar@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Gastroenterology, Sao Paulo University Medical School

Study Record Dates

• First Submitted: July 16, 2007
• First Posted: July 17, 2007
• Study Start: August 1, 2007
• Primary Completion: August 1, 2013
• Study Completion: October 1, 2013
• Last Updated: September 28, 2012

Record last verified: 2012-09

Locations

BR (1)