此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Effects of Hemp Oil on Markers of Optimal Wellness, Stress Resilience and Recovery in Healthy Subjects

The purpose of this placebo-controlled, double-blind study is to determine the effects of a commercially available (i.e. dietary supplement) Hemp Oil Extract product on various markers of physical and mental stress resilience, and perceived recovery from normal daily physical & mental stress. Secondary purposes are to collect information on perceived appetite, mood, feelings of wellbeing, sleep quality, body composition and safety information via standard clinical chemistry panels of sera and plasma.

研究概览

地位

完全的

研究类型

介入性

注册 (实际的)

65

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ohio
      • Canfield、Ohio、美国、44406
        • The Center for Applied Health Sciences

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 55年 (成人)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Subjects provide written and dated informed consent to participate in an IRB approved study.
  • Subjects are in good health as determined by medical history and routine blood chemistries.
  • Subjects are male or female between the ages of 18 and 55 (inclusive).
  • Female subjects must agree to use barrier contraceptive methods during sexual intercourse for the duration of the study. All females will undergo pregnancy testing (urine HCG screen) before being screened and at each visit unless they present evidence of surgical sterilization by tubal ligation, bilateral oophorectomy or hysterectomy.
  • Subjects have a Body Mass Index of 25-35.
  • Subjects are willing and able to comply with the daily activity and supplement protocol.
  • Subject is willing and able to comply with the visit schedule.
  • Subjects are normotensive (resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg), have a normal resting heart rate (<90 per minute).

Exclusion Criteria:

  • Subjects that currently exercise more than three times per week.
  • Subject has used weight loss medications within the past three months of Screening visit.
  • Subject is on thyroid medication at a dose that is not considered stable. Stable is defined as using the same dose consistently for at least 90 days.
  • Subjects with any metabolic disorder including known electrolyte abnormalities, diabetes (or fasting glucose ≥126 mg/dL at the screening visit), unstable or unmanaged thyroid disease, or hypogonadism.
  • Subjects with a history of hepato-renal, musculoskeletal, autoimmune, neurologic disease, or any other medical condition deemed exclusionary by the medical staff.
  • Subjects taking anti-anxiety, anti-depressant, psychotropic hyperlipidemic, hypoglycemic, anti-coagulant or androgenic medications; nitrates/nitrate derivatives, and PDE-5 inhibitors; and other vasodilatory agents such as calcium channel blockers and beta blockers.
  • Subject has an active gastrointestinal disorder such as peptic ulcer disease or malabsorption syndrome (mild lactose intolerance or gastroesophageal reflux diseases are acceptable).
  • Subjects who have taken anabolic steroids, growth hormone, IGF-1 or other anabolic drugs within the past year.
  • Subjects who are pregnant, trying to become pregnant, or who are nursing.
  • Female participants who are < 120 days postpartum before enrolling.
  • Subjects who have taken any nutritional supplements that may affect sleep, mood or healthy stress response (including but not limited to Ashwagandha, Valerian root, Melatonin, L-theanine, 5-HTP), or that may affect anabolic/catabolic hormone levels (e.g., androstenedione, DHEA, etc.) within four weeks prior to the start of the study.
  • Subjects who have gained or lost more than 5 lbs within 30 days prior to the start of the study.
  • Subjects with history of heart disease, peripheral vascular disorders or vaso-occlusive or vasospastic syndromes, psychiatric disorders, or history of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin.
  • Subject has a recent history of (within 3 months of Screening Visit) or strong potential for alcohol or substance abuse. Alcohol abuse defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
  • Subject has been hospitalized within the past one-year for any mental or emotional illness.
  • Subject has an active infection or sign/symptoms of an infection.
  • Subject has dietary tendencies that may be representative of disordered eating (in the opinion of the Investigator).
  • Subjects who had any known allergy to any of the ingredients in any of the test products.
  • Subjects who are participating in other research studies.
  • Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
  • Subjects who smoked or used any tobacco or nicotine containing products within the past year.
  • Subjects with syndromes or prescribed medications that may influence body composition, or CVD (e.g. prednisone, Ritalin, Adderall, GH); also protease inhibitors/antivirals (nucleic acid analogs).
  • Subjects with orthopedic limitations or injuries that would preclude them from the physical activity intervention in this study.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Hemp arm
Randomly assignment to Hemp arm (60 mg/day of hemp oil extract x 6 weeks)
Hemp oil
安慰剂比较:Placebo arm
Randomly assigned to Placebo arm (60 mg/day of cellulose x 6 weeks)
Hemp oil

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Sleep quality
大体时间:baseline
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
baseline
Sleep quality
大体时间:week 3
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
week 3
Sleep quality
大体时间:week 6
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
week 6
Stress
大体时间:Baseline
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Baseline
Stress
大体时间:Week 3
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Week 3
Stress
大体时间:Week 6
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Week 6
Well-being
大体时间:Baseline
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Baseline
Well-being
大体时间:Week 3
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Week 3
Well-being
大体时间:Week 6
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Week 6
Readiness to perform exercise
大体时间:Baseline
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Baseline
Readiness to perform exercise
大体时间:Week 3
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Week 3
Readiness to perform exercise
大体时间:Week 6
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Week 6
Appetite
大体时间:Baseline
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Baseline
Appetite
大体时间:Week 3
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Week 3
Appetite
大体时间:Week 6
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
Week 6
Body composition
大体时间:Baseline
DXA measurement
Baseline
Body composition
大体时间:Week 3
DXA measurement
Week 3
Body composition
大体时间:Week 6
DXA measurement
Week 6

次要结果测量

结果测量
措施说明
大体时间
Blood pressure
大体时间:Baseline
Measured in mm Hg
Baseline
Blood pressure
大体时间:Week 3
Measured in mm Hg
Week 3
Blood pressure
大体时间:Week 6
Measured in mm Hg
Week 6
Plasma liver enzyme
大体时间:Baseline
Alanine aminotransferase
Baseline
Plasma liver enzyme
大体时间:Week 3
Alanine aminotransferase
Week 3
Plasma liver enzyme
大体时间:Week 6
Alanine aminotransferase
Week 6
Plasma liver enzyme
大体时间:Baseline
Aspartate aminotransferase
Baseline
Plasma liver enzyme
大体时间:Week 3
Aspartate aminotransferase
Week 3
Plasma liver enzyme
大体时间:Week 6
Aspartate aminotransferase
Week 6
Plasma Lipid panel
大体时间:Baseline
Total cholesterol, LDL, HDL and triglycerides
Baseline
Plasma Lipid panel
大体时间:Week 3
Total cholesterol, LDL, HDL and triglycerides
Week 3
Plasma Lipid panel
大体时间:Week 6
Total cholesterol, LDL, HDL and triglycerides
Week 6

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年8月27日

初级完成 (实际的)

2019年8月29日

研究完成 (实际的)

2019年8月29日

研究注册日期

首次提交

2020年3月2日

首先提交符合 QC 标准的

2020年3月2日

首次发布 (实际的)

2020年3月4日

研究记录更新

最后更新发布 (实际的)

2020年3月5日

上次提交的符合 QC 标准的更新

2020年3月3日

最后验证

2020年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • CVSI-001-2018

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Hemp arm的临床试验

3
订阅