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临床试验/NCT03008785
NCT03008785已完成不适用

Effect of Isoflavone Supplementation Associated With Physical Exercise on Blood Pressure, Lipic and Inflamatory Profile, Body Composition and Hydratation and Climacteric Symptoms in Postmenopausal Women

Federal University of Uberlandia2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2015年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
2
主要终点
Change in blood pressure

研究概览

简要总结

This study evaluate if 10 weeks of mixed exercise combined with isoflavones could have greater effects on climacteric symptoms, body composition and hydratation, lipidic and inflamatory profile than exercise alone in postmenopausal women. the participants will be randomly assigned to the group: placebo and exercise or 100mg of isoflavone and exercise.

详细描述

Several endocrine metabolic changes occur during the climacteric period, due to the lack of estrogen and also by the aging process and some studies show that ingestion of isoflavones by postmenopausal women may have benefits. Theoretically the isoflavone potentiate the effects obtained during exercise

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy postmenopausal woman
  • to be able to practice exercises on treadmill and weight exercises
  • without physical complications that prevent the execution of physical exercises
  • have no history of cardiovascular disease, diabetes, renal pathologies or hypertension

排除标准

  • use hormone therapy or isoflavone
  • use drugs that interfere with lipid and antihypertensive metabolism

研究组 & 干预措施

group isoflavone and exercise

Experimental

The isoflavone group received daily 100mg of isoflavones.

干预措施: exercise (Other)

group isoflavone and exercise

Experimental

The isoflavone group received daily 100mg of isoflavones.

干预措施: isoflavone (Other)

group placebo and exercise

Experimental

The placebo group received 100mg containing starch of corn.

干预措施: exercise (Other)

group placebo and exercise

Experimental

The placebo group received 100mg containing starch of corn.

干预措施: Placebo (Other)

结局指标

主要结局

Change in blood pressure

时间窗: Change in blood pressure in 10 weeks intervention

Evaluate change in blood pressure through ambulatory 24-hour blood pressure monitoring used before the begin of intervention and after 10 weeks.

次要结局

  • Human cytokines (Flow Cytometry)(before and after 10 weeks)
  • Climateric Symptoms (Menopause Rating Scale)(before and after 10 weeks)
  • Lipid profile (enzymatic colorimetric method)(before and after 10 weeks)
  • Antioxidant capacity(before and after 10 weeks)
  • Total protein(before and after 10 weeks)
  • Body Composition(before and after 10 weeks)
  • Phase Angle(before and after 10 weeks)
  • Oxidative stress (SOD, Catalase and TBARS activity)(before and after 10 weeks)
  • Climateric Symptoms (Kupperman-Blatt Index)(before and after 10 weeks)
  • Climateric Symptoms (Cervantes Scale)(before the begin the intervention and after 10 weeks)

研究者

发起方
Federal University of Uberlandia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Juliene Gonçalves Costa

Guilherme Morais Puga PhD

Federal University of Uberlandia

研究点 (2)

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