Acute Pharmacokinetics of Create Wellness Gummies in Healthy Adults
研究概览
详细说明
To examine and compare acute effects of Create Wellness creatine gummies and creatine monohydrate powder on blood creatine levels.
Prior to the baseline visit, each participant will be sent an electronic version of the informed consent to review participation details. Those interested will complete a phone screening for inclusion/exclusion criteria. If the participant qualifies for the study and is interested in participating, verbal consent will be obtained. An electronic link for written consent and a self-reported medical health history questionnaire will be sent after verbal consent. Each participant will provide electronic written informed consent and complete the health/medical history questionnaire. Following written electronic consent, health history will be reviewed by the research team to confirm eligibility.
Visits 1 & 2: Participants will be asked to arrive to the laboratory after an 8-hour overnight fast from caloric foods and beverages and having abstained from vigorous exercise, caffeine, alcohol, and tobacco for the previous 24-hours. Anthropometrics (height and weight) and body composition (via multi-frequency bioelectrical impedance analysis) will be obtained upon arrival and a urine sample will be collected to determine acute hydration and pregnancy status for female participants. Blood samples will then be obtained from the antecubital region at baseline and 30-min, 1-hour, 2-hours, 3-hours, 4-hours, and 5-hours following oral ingestion of the assigned supplement. Participants will be randomized to supplement order of Create Wellness creatine gummies (3 gummies, 4.5 grams of creatine monohydrate) or creatine monohydrate powder (4.5 grams creatine monohydrate in 240 mL water). Gastrointestinal surveys will be also be collected. All research visits will take place at the ATHENA Laboratory in the Health and Exercise Science Department at the University of Oklahoma, Norman Campus. All data will be collected by the Principal Investigator and ATHENA Laboratory Research Assistants.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Sam R. Moore, PhD
- 电话号码:4053252542
- 邮箱:samray@ou.edu
学习地点
-
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Oklahoma
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Norman、Oklahoma、美国、73019
- 招聘中
- ATHENA Laboratory
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接触:
- Sam R. Moore, PhD
- 电话号码:405-325-2542
- 邮箱:samray@ou.edu
-
-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Adults between the ages of 18-45 yrs
- Body mass index of <35 kg/m2
- Recreationally active [(≥30 minutes of moderate-intensity physical activity per week as defined by the International Physical Activity Questionnaire (IPAQ)]
- Healthy and free from major diseases as determined from screening call and health history questionnaire.
- Agrees to complete pre-assessment guidelines (8-hour fast from caloric foods and beverages, 24-hour abstention from vigorous physical activity, caffeine, alcohol, and tobacco).
Exclusion Criteria:
- Chronic kidney disease, liver disease, chronic obstructive pulmonary disease, or cancer.
- Currently using medications that may directly impact the primary outcomes including: diuretics and corticosteroids).
- Currently using creatine monohydrate
- Severely impaired hearing or speech or inability to speak English.
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Sequence A (Gummy, Powder)
|
Create Wellness creatine gummies provide 4.5 grams of creatine monohydrate in a 3 gummy serving size.
4.5 grams of creatine monohydrate powder (Creapure®) dissolved in 240 mL of water.
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实验性的:Sequence B (Powder, Gummy)
|
Create Wellness creatine gummies provide 4.5 grams of creatine monohydrate in a 3 gummy serving size.
4.5 grams of creatine monohydrate powder (Creapure®) dissolved in 240 mL of water.
|
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 |
|---|---|---|
|
Peak plasma concentration (Cmax)
大体时间:0 to 5-hours following supplementation.
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Maximum plasma concentration observed.
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0 to 5-hours following supplementation.
|
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Time to peak plasma concentration (Tmax)
大体时间:0 to 5-hours following supplementation.
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Time to reach maximum plasma concentration.
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0 to 5-hours following supplementation.
|
|
Area under the curve (AUC)
大体时间:0 to 5-hours following supplementation.
|
Area under the plasma concentration curve.
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0 to 5-hours following supplementation.
|
合作者和调查者
调查人员
- 首席研究员:Sam R Moore, PhD、University of Oklahoma
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 19428
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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
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