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临床试验/ACTRN12621000810819
ACTRN12621000810819进行中(未招募)未知

The effectiveness of a lactobacilli- based probiotic food supplement on bone metabolism and bone mineral density in Australian early postmenopausal women: A double- blind randomised placebo- controlled trial

a Trobe University0 个研究点目标入组 114 人开始时间: 2021年6月28日最近更新:

试验速览

阶段
未知
状态
进行中(未招募)
发起方
入组人数
114

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Prevention
盲法
Blinded (masking used)

入排标准

年龄范围
45 Years 至 65 Years(—)
性别
Female

入选标准

  • Willingness to participate and availability throughout the study period
  • - 10-year major fracture risk (based on FRAX score) ranging from 5% in 45-year-old women to 15% in 65-year-old women.
  • - QUS heel BMD T-score greater than -2.5 standard deviation
  • - Early postmenopausal women, i.e. < 6 years since menopause
  • - Signed informed consent to participate to the study

排除标准

  • - QUS heel BMD T-score less than or equal to -2.5 (i.e. potential presence of osteoporosis)
  • - Normal menstrual cycle or more than 6 years post menopause
  • - Younger than 45 years old and older than 65 years old.
  • - Medication that affects BMD
  • - Presence of disease: diabetes, untreated hyperthyroidismorhypothyroidism, hyperparathyroidism, impaired renal and liver function, malignancy diagnosed during the last 5 years, inflammatory bowel disease, celiac disease, chronic obstructive pulmonary disease, rheumatoid arthritis.
  • - Smoking or use of nicotine-containing products (currently or during the last six [6] months).
  • - Alcohol consumption more than 4 units per day.

研究者

发起方
a Trobe University

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