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临床试验/NCT04966494
NCT04966494已完成不适用

Effect of the Consumption of a Common Bean (Phaseolus Vulgaris L.) and Oats Snack Bar on the Proteomic Profile of Human Mononuclear Cells

Universidad Autonoma de Queretaro0 个研究点目标入组 100 人开始时间: 2013年10月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
主要终点
Triglycerides

研究概览

简要总结

Hypertriglyceridemia is a serious condition in the Mexican population and it is considered a major risk factor for cardiovascular disease. Current efforts to prevent dyslipidemia and lipids alteration include the development of functional products as an alternative for the management of hypertriglyceridemia. Common beans (Phaseolus vulgaris L.) are a recognized good source of bioactive compounds, mainly phenolic compounds, total dietary fiber (insoluble and soluble fiber, resistant starch and oligosaccharides), saponins, and phytosterols that exert hypolipidemic effects. In this sense, the development of beans-based food products is an alternative for improving the general health status. In previous work, a beans-oats snack bar formulation was found to be a promising potential functional product. In order to validate those results, the aim of this works was to assess a clinical trial was conducted with Mexican women to assess the effect of daily consumption of the functional product on serum triglycerides and certain plasma proteins involved in lipids metabolism in a clinical trial. The clinical trial was 2 months, randomized parallel study where 32 women with elevated triglycerides were randomized into the treatment group and control group. The Control group received nutritional orientation whereas the treatment group received the orientation and consumed 50 g of the product per day. Fasting blood samples were collected at baseline and the end of the study, obtaining serum and plasma for analysis of lipids profile, glucose, and biomarkers. To determine changes in plasma proteins, a 182 protein Human Obesity Antibody Array was used, and the results were analyzed using a bioinformatic-based analysis from Ingenuity Pathways Analysis (QIAGEN)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • No current diagnoses of illnesses.
  • Triglycerides levels among 150 and 350 mg/dL.
  • No allergies to common beans and oats.
  • Not pregnant or lactating.

排除标准

  • If they had current diagnoses of diabetes, hypertension, irritable bowel syndrome, or cancer.
  • Taking anti-inflammatory drugs.
  • Fasting glucose >100 mg/dL, total cholesterol >240 mg/dL, LDL C>160 mg/dL.
  • Reported intolerances to BOSB ingredients.

结局指标

主要结局

Triglycerides

时间窗: 8 weeks

Significant change

Glucose

时间窗: 8 weeks

Significant change

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ivan Luzardo-Ocampo

Associate Researcher

Universidad Autonoma de Queretaro

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