Impact of Flaxseed on the Syndrome Metabolic Inflammation

May 21, 2014 updated by: Julio Sergio Marchini, University of Sao Paulo

Flaxseed and Lignans: Effect of Consumption on Nutritional and Inflammatory Markers

This study aims to evaluate the effects of enterolignanas of flaxseed on nutritional and inflammatory indicators in male workers of a food industry.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14049-900
        • Clinical Hospital of Ribeirao Preto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Work in the manufacturing company in the city of Itu-SP.
  • Have at least three of the following cardiovascular risk factors: waist circumference ≥ 90 cm; overweight or obese characterized by BMI ≥ 25 kg/m²; fasting total cholesterol ≥ 200 mg/dL, LDL- cholesterol ≥ 130 mg/dL and HDL-cholesterol < 40 mg/dL, triglycerides ≥ 150 mg/dL; glycemia ≥100 mg/dL; and hypertension characterized by systolic blood pressure ≥140 mm/Hg and/or diastolic blood pressure ≥ 90 mm/Hg.

Exclusion Criteria:

- Female gender

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
In the group with 11 volunteers, the control group did no change in normal food intake.
Experimental: Flaxseed group
In this group with 14 volunteers, they received 50% carbohydrate, 31% fat, 19% protein and 60 g of flaxseed powder / day during the period of study.
Other: Flaxseed or rice raw powder ingestion
The experimental groups received isocaloric diets and different proportions of carbohydrates, and the introduction of 60g of brown flaxseed or rice raw powder. Flaxseed and raw rice were crushed weekly by minimal particle type mill and appropriate sieves for fine grinding grain with a degree to 250 mm/micrometers. After crushing flaxseed and raw rice, they were weighed in semi-analytical balance. The addition of flaxseed or raw rice powder was made in the collation (40 g added to milk) and lunch (20 g added to baked beans). The volunteers received flaxseed or rice raw powder, portioned to be used for 42 days, including the weekends.
Experimental: Rice and low carb group
In this group with 13 volunteers, they received 35% carbohydrate, 46% fat, 19% protein and 60g of raw rice powder / day during the period of study.
Other: Flaxseed or rice raw powder ingestion
The experimental groups received isocaloric diets and different proportions of carbohydrates, and the introduction of 60g of brown flaxseed or rice raw powder. Flaxseed and raw rice were crushed weekly by minimal particle type mill and appropriate sieves for fine grinding grain with a degree to 250 mm/micrometers. After crushing flaxseed and raw rice, they were weighed in semi-analytical balance. The addition of flaxseed or raw rice powder was made in the collation (40 g added to milk) and lunch (20 g added to baked beans). The volunteers received flaxseed or rice raw powder, portioned to be used for 42 days, including the weekends.
Experimental: Flaxssed and low carb group
In this group with 14 volunteers, they received 32% carbohydrate, 47% fat, 21% protein and 60 g of flaxseed powder / day during the period of study.
Other: Flaxseed or rice raw powder ingestion
The experimental groups received isocaloric diets and different proportions of carbohydrates, and the introduction of 60g of brown flaxseed or rice raw powder. Flaxseed and raw rice were crushed weekly by minimal particle type mill and appropriate sieves for fine grinding grain with a degree to 250 mm/micrometers. After crushing flaxseed and raw rice, they were weighed in semi-analytical balance. The addition of flaxseed or raw rice powder was made in the collation (40 g added to milk) and lunch (20 g added to baked beans). The volunteers received flaxseed or rice raw powder, portioned to be used for 42 days, including the weekends.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory markers and hormones blood levels
Time Frame: After 12-hour fast, in the first and 42th day of intervention

For detection of insulin by chemiluminescence, we used the IMMULITE 1000® SYSTEMS - SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS (SIEMENS) (Los Angeles, USA).

The determination of ultra-sensitive CRP (C-reactive protein) by immunoturbidimetric assay was performed with the COBAS® MIRAPLUS - ROCHE (USA). The Tumor Necrosis Factor (TNF-α), leptin, and adiponectin were measured by enzyme immunoassay method, using kits of LINCOPLEX-LUMINEX®, manufactured by Millipore Corporation (USA). Determination of 8-Iso-Prostaglandin F2a (serum isoprostane) was performed by enzyme immunoassay with ASSAYS® DESIGNS kit, Inco, USA.
After 12-hour fast, in the first and 42th day of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood lipid profile
Time Frame: After 12-hour fast, in the first and 42th day of intervention
The determination of total cholesterol, high density lipoprotein (HDL-c), triglyceride, glucose and uric acid was performed by enzymatic method, with HITACHI® 912 - ROCHE (Japan). The reagent used for measurement of total cholesterol and triglyceride was CHOD-PAP, ROCHE (Japan); for HDL-c: Bioclin K071 (Japan); for glucose: GOD-PAD (Roche) (Japan); and for uric acid was Uric Acid Plus (URICASE) (Japan). To determine the values of low density lipoprotein (LDL-c) the Friedewald Formula was used.
After 12-hour fast, in the first and 42th day of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Julio S Marchini, PhD, Ribeirão Preto Medical School. São Paulo University (USP)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

May 5, 2014

First Submitted That Met QC Criteria

May 5, 2014

First Posted (Estimate)

May 7, 2014

Study Record Updates

Last Update Posted (Estimate)

May 23, 2014

Last Update Submitted That Met QC Criteria

May 21, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCRP 4244/2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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