Flaxseed and Lignans: Effect of Consumption on Nutritional and Inflammatory Markers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Inflammatory markers and hormones blood levels
研究概览
简要总结
This study aims to evaluate the effects of enterolignanas of flaxseed on nutritional and inflammatory indicators in male workers of a food industry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Female gender
研究组 & 干预措施
Control group
In the group with 11 volunteers, the control group did no change in normal food intake.
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.
干预措施: Flaxseed or rice raw powder ingestion (Other)
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.
干预措施: Flaxseed or rice raw powder ingestion (Other)
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.
干预措施: Flaxseed or rice raw powder ingestion (Other)
结局指标
主要结局
Inflammatory markers and hormones blood levels
时间窗: 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.
次要结局
- Blood lipid profile(After 12-hour fast, in the first and 42th day of intervention)
研究者
Julio Sergio Marchini
Flaxseed and lignans: effect of consumption on nutritional and inflammatory markers
University of Sao Paulo