Impact of Flaxseed on the Syndrome Metabolic Inflammation

University of Sao Paulo52 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Metabolic Syndrome

Interventions

Flaxseed or rice raw powder ingestionOTHER

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.

Eligibility

Sex: MALEMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Clinical Hospital of Ribeirao Preto

Ribeirão Preto, São Paulo, Brazil

Outcomes

Primary Outcomes

Inflammatory markers and hormones blood levels

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.

Time frame: After 12-hour fast, in the first and 42th day of intervention

Secondary Outcomes

Blood lipid profile

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.

Time frame: After 12-hour fast, in the first and 42th day of intervention

Data from ClinicalTrials.gov

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