临床试验/NCT01472393

NCT01472393Unknown不适用

A Randomized Controlled Trial: Effects of Creatine Supplementation on Bone Mass and Turnover and Muscle Function in Healthy Postmenopausal Women

University of Sao Paulo1 个研究点分布在 1 个国家目标入组 200 人开始时间: 2011年11月1日最近更新: 2015年1月30日

适应症

干预措施

试验速览

阶段: 不适用
发起方: University of Sao Paulo
入组人数: 200
试验地点: 1
主要终点: bone mineral density (BMD)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Animal, in vitro and small-scale studies have suggested that creatine supplementation may augment bone mass. This clinical trial aims to investigate the effects of a 2-year creatine supplementation protocol on bone mass in postmenopausal women.

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: Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围: 50 Years 至 80 Years（Adult, Older Adult）
性别: Female
接受健康志愿者: 是

入选标准

•healthy postmenopausal women
•T-score at lumbar spine, or femoral neck or total femur of between -1SD and -2.5SD

排除标准

•drugs or dietary supplements that may affect bone metabolism (e.g., bisphosphonates, AINEs, hormone replacement therapy, calcium, vitamin D, creatine supplementation)
•low BMI (< 18.5 Kg/m2).

研究组 & 干预措施

Creatine supplementation

Experimental

干预措施: Creatine supplementation (Dietary Supplement)

Placebo

Placebo Comparator

干预措施: dextrose (placebo) (Dietary Supplement)

结局指标

主要结局

bone mineral density (BMD)

时间窗: 12 and 24 months

次要结局

history of falls(24 months)
bone microarchitecture(12 and 24 months)
muscle function(12 and 24 months)
laboratory parameters(12 and 24 months)
bone markers(12 and 24 months)
lean mass(12 and 24 months)

研究者

发起方

University of Sao Paulo

申办方类型

Other

责任方

Principal Investigator

主要研究者

Bruno Gualano

Professor

University of Sao Paulo

研究点 (1)

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