Impact of Flaxseed on the Syndrome Meta… | Clinical Trial

Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Inflammation Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Hospital of Ribeirao Preto

Ribeirão Preto, São Paulo, 14049-900, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flaxseed or rice raw powder ingestion

Other

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.

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2007
First posted: May 7, 2014
Registry last updated: May 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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