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临床试验/ACTRN12622001161718
ACTRN12622001161718招募中未知

Effects of ruminant milk on nutrition and digestive comfort in older women: a randomised, controlled trial

Riddet Institute0 个研究点目标入组 160 人开始时间: 2022年8月24日最近更新:
适应症

试验速览

阶段
未知
状态
招募中
发起方
入组人数
160

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
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
60 Years 至 80 Years(—)
性别
Female

入选标准

  • Women who live independently and are free from serious medical illness such as cancer, uncontrolled diabetes or cardiovascular disease, with a Body Mass Index between 18.5 to 30 kg/m2, and do not undertake more than 2 hours of structured exercise each day.

排除标准

  • Inability to give informed consent
  • Taken antibiotics within the month before starting the study
  • Use of certain prescribed medication or recreational drugs within the last three months that could affect the gastrointestinal tract: opioids, non-steroidal anti-inflammatory drugs, proton pump inhibitors, laxatives, prebiotic or probiotic supplements.
  • Medical history of gastrointestinal surgery or disorders (inflammatory bowel disease, ulcerative colitis, coeliac disease, Crohn's disease), cardiorespiratory problems, uncontrolled diabetes mellitus, bleeding disorders, sleep disorders, psychiatric conditions (major depressive disorder, schizophrenia, bipolar disorder, post-traumatic stress disorder)
  • Alarm features associated with significant gastrointestinal or other disorders, such as burning pain in the epigastrium which increases during the night and wakes up the patient; frequent vomiting; loss of appetite; lower gastrointestinal bleeding; odynophagia; dysphagia; palpable abdominal mass; lymphadenopathy; jaundice.
  • Significant dietary changes within the month before starting the trial (i.e., being on a controlled diet or dietary weight loss regimen)
  • Dairy intolerance of, or ruminant milk allergy
  • High habitual milk intake (> 500 mL per day on average)
  • Malnutrition Screening Tool (MST) score of 2 or more points
  • Cigarette smoking or other use of tobacco or nicotine-containing products
  • Excessive alcohol intake >20g of pure alcohol (2 drinks)/d on average (>21 standard drinks a week)
  • Inability or unwillingness to comply with the study procedures

研究者

发起方
Riddet Institute

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