Impact of Flaxseed on the Syndrome Metabolic Inflammation

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Other: Flaxseed or rice raw powder ingestion

• Registration Number: NCT02132728
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2014-05
• Study First Submitted: 2014-05-05
• Study First Submitted QC: 2014-05-05
• Study First Posted: 2014-05-07
• Last Update Submitted: 2014-05-21
• Last Update Posted: 2014-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 52

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.

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Exclusion Criteria

• Female gender

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flaxssed and low carb group	Flaxseed or rice raw powder ingestion	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.
Flaxseed group	Flaxseed or rice raw powder ingestion	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.
Rice and low carb group	Flaxseed or rice raw powder ingestion	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.

Primary Outcome Measures

Name	Time	Method
Inflammatory markers and hormones blood levels	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.

Secondary Outcome Measures

Name	Time	Method
Blood lipid profile	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.

Trial Locations

Locations (1)

Clinical Hospital of Ribeirao Preto; 🇧🇷 Ribeirão Preto, São Paulo, Brazil