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临床试验/NCT02137434
NCT02137434Unknown不适用

Influence of Dietary and Supplementary Calcium Over the Postprandial Effects of a Fatty Meal on Metabolism Profile, Blood Pressure, Oxidative Stress, and Endothelial Function of Obese Women.

Rio de Janeiro State University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2014年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
15
试验地点
2
主要终点
Blood pressure

研究概览

简要总结

The purpose of the study is to investigate calcium acute influence over the postprandial effects of a fatty meal on serum calcium, plasma glucose and triglycerides, blood pressure, oxidative stress, and endothelial function in obese women.

详细描述

Studies suggest that dietary calcium intake is inversely associated with cardiovascular disease, but supplementary calcium appears to be associated with raised risk of cardiovascular events. Fatty meals lead to oxidative and inflammation which seems to interfere in postprandial dismetabolism, a predictor of cardiovascular events. To investigate calcium acute influence over the postprandial effects of a fatty meal a crossover, controlled, and randomized clinical trial will be conducted with obese adult women who will be randomized into one of the three interventions, characterized by a fatty meal with different contents of calcium: low calcium (40 mg), high dietary calcium (540 mg from non-fat milk), and high supplementary calcium (540 mg from calcium carbonate). Each participant will receive all three meals and one of them every week. Before meals' intake blood sample will be collected and endothelial function assess will be performed. Participants will eat the specific meal and endothelial function will be assessed again after 120 minutes. Blood sample collections will be repeated every 60 minutes after meal's intake to perform latter biochemical analyzes to determine: 8-isoprostane levels, to assess oxidative stress status; triglycerides; glucose; insulin; and serum calcium. Blood pressure will be continuously assessed during 25 minutes before meals' intake and during 2 hours after it.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Single (Participant)

入排标准

年龄范围
25 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • body mass index (BMI) greater than or equal to 30 kg/m2 and below 40 kg/m2
  • habitual dietary calcium intake below 500 mg per day

排除标准

  • dietary supplements or drugs that could interfere with body weight, metabolic profile and blood pressure
  • thyroid dysfunction
  • hypertension
  • angina pectoris
  • heart kidney or liver failure
  • intestinal malabsorption
  • acute or chronic inflammation
  • HIV infection
  • autoimmune diseases
  • chronic obstructive pulmonary disease
  • dyslipidemia with indication for drug treatment
  • history of myocardial infarction or stroke
  • pregnancy and lactation
  • menopause

结局指标

主要结局

Blood pressure

时间窗: Blood pressure will be assessed continuously 25 min before meals' intake and 2 hours after it.

Blood pressure will be assessed by digital photoplethysmography.

次要结局

  • Endothelial function(Endothelial function will be assessed after meals' intake and 2 hours after it.)

研究者

发起方
Rio de Janeiro State University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Felipe Sanjuliani

Associate Professor

Rio de Janeiro State University

研究点 (2)

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