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临床试验/ACTRN12621000501842
ACTRN12621000501842
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Effects of a saffron extract (affron) on mood, sleep, physical, and mental recovery in recreationally-active adults

Clinical Research Australia0 个研究点目标入组 62 人开始时间: 2021年4月29日最近更新:

概览

阶段
未知
状态
已完成
发起方
Clinical Research Australia
入组人数
62

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
Blinded (masking used)

入排标准

年龄范围
18 Years 至 65 Years(—)
性别
All

入选标准

  • 1\. Healthy adults (male and female) 18 to 65 years
  • 2\. Engaging in non\-professional, moderate\-to\-intensive aerobic exercise greater than 3 times per week comprising the following activities: running, cycling, swimming, tennis, aerobics, boxing
  • 3\. Exercise sessions are greater than 45 minutes and commenced more than 6 months ago
  • 4\. Engage in moderate\-to\-intensive aerobic exercise no more than 14 hrs a week
  • 5\. Non\-smoker
  • 6\. BMI between 18 and 30 kg/m2
  • 7\. No plan to commence new treatments over the study period
  • 8\. Understand, willing and able to comply with all study procedures
  • 9\. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.

排除标准

  • 1\. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gastrointestinal disease requiring regular use of medications, gallbladder disease/gallstones/biliary disease, autoimmune disease, endocrine disease, acute or chronic pain condition
  • 2\. Diagnosis of medical or psychiatric conditions including but not limited to: psychiatric disorder (other than mild\-to\-moderate depression or anxiety), neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury), or cancer/malignancy
  • 3\. Regular medication intake including but not limited to anticoagulants and anti\-hypertensive drugs, anticholinergics, acetylcholinesterase inhibitors, or steroid medications.
  • 4\. Change in medication in the last 3 months or an expectation to change during the study duration
  • 5\. Currently experiencing significant injuries that may affect the ability to engage in exercise
  • 6\. Taking vitamins, herbal, or other nutritional supplements that are reasonably expected to influence study measures.
  • 7\. Current or 12\-month history of illicit drug abuse
  • 8\. Alcohol intake greater than 14 standard drinks per week
  • 9\. Consume more than 3 cups a day of coffee (or other caffeinated beverage).
  • 10\. Any significant surgeries over the last year

研究者

发起方
Clinical Research Australia

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