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Creatine for Recovery and Thinking in Mothers (CREATE-MOM)

2026年8月26日 更新者：University of North Carolina, Chapel Hill

Creatine for Recovery, Executive Function, Activity, Thinking & Energy in Mothers (CREATE-MOM)

The purpose of this randomized, double-blind, parallel-group trial is to compare the effects of two doses of creatine monohydrate (5 g/day versus 10 g/day) administered for four weeks in postpartum women. The study will evaluate exercise performance, post-exercise recovery, cognitive function, and brain creatine concentrations in a sub-sample.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Postpartum women frequently experience changes in physical performance, recovery, cognition, sleep quality, and mood. Creatine supplementation may enhance energy availability in skeletal muscle and brain tissue, potentially improving exercise performance, recovery, and cognitive function. This study will enroll 40 postpartum women and randomly assign participants in a 1:1 ratio to receive either 5 g/day or 10 g/day of creatine monohydrate for four weeks in a double-blind fashion. Assessments will be conducted before and after supplementation and will include repeated sprint ability testing, skeletal muscle oxygen recovery, and cognitive testing. A subsample of 20 participants will undergo magnetic resonance spectroscopy to assess brain creatine stores.

研究类型

介入性

注册 (估计的)

40

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。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • North Carolina
      • Chapel Hill、North Carolina、美国、27599
        • Applied Physiology Laboratory
        • 接触：
        • 首席研究员：
          • Abbie Smith-Ryan, PhD

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

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • 6 weeks -12 months postpartum
  • Body mass index of 18.5-34.9 kg/m2
  • Cleared to resume physical activity

Exclusion Criteria:

  • Experienced a musculoskeletal injury, excluding a Cesarean delivery,within the past three months that inhibits participation in the study.
  • Has 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).
  • Has uncontrolled hypertension or diabetes, or has recently started medication, without a stable dose for 3 consecutive months.
  • Currently using creatine monohydrate or other performance-enhancing supplements
  • Has a self-identified or clinically diagnosed eating disorder
  • Taking or having supplemented with creatine monohydrate in the last 28-days
  • Medical contradictions for physical exercise
  • Has participated in another clinical trial within 4-weeks prior to enrollment that in the opinion of the PI would influence the results.
  • Has severely impaired hearing or speech or inability to speak English.
  • Unwilling or unable to comply with the study protocol, including abstaining from caffeine, tobacco, alcohol, and physical activity before testing days.
  • Is currently pregnant.
  • Has a known allergy to the transducer gel used for the ultrasound
  • Has a known allergy to creatine monohydrate

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：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Low-Dose Creatine Monohydrate
Participants consume 5 grams per day of creatine monohydrate for 28 consecutive days.
膳食补充剂：Creatine Monohdyrate
Creatine monohydrate taken daily mixed with 6-8 oz of water.
实验性的：High-dose Creatine Monohydrate
Participants consume 10 grams per day of creatine monohydrate for 28 consecutive days.
膳食补充剂：Creatine Monohdyrate
Creatine monohydrate taken daily mixed with 6-8 oz 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
Repeated Sprint Ability Peak Power
大体时间：Change from baseline to 4 weeks post-supplementation.
Peak power (Watts) measured during a repeated sprint ability cycling test.
Change from baseline to 4 weeks post-supplementation.
Fatigue Index
大体时间：Change from baseline to 4 weeks post-supplementation.
Fatigue index (%) calculated from repeated sprint ability testing.
Change from baseline to 4 weeks post-supplementation.

次要结果测量

结果测量
措施说明
大体时间
Skeletal Muscle Oxygen Recovery
大体时间：Change from baseline to 4 weeks post-supplementation
Recovery rate constant of skeletal muscle oxygen consumption following exercise measured by near-infrared spectroscopy and arterial occlusion procedures.
Change from baseline to 4 weeks post-supplementation
Executive Function
大体时间：Change from baseline to 4 weeks post-supplementation
Executive function measured using the NIH Toolbox Flanker Inhibitory Control and Attention Test.
Change from baseline to 4 weeks post-supplementation
Working Memory
大体时间：Change in baseline to 4 weeks post-supplementation.
Working memory measured using the NIH Toolbox List Sorting Working Memory Test.
Change in baseline to 4 weeks post-supplementation.
Brain Creatine Concentration
大体时间：Change from baseline to 4 weeks post-supplementation
Brain phosphocreatine and related bioenergetic metabolites assessed using phosphorus magnetic resonance spectroscopy (³¹P-MRS) in the imaging subsample
Change from baseline to 4 weeks post-supplementation

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。

赞助

University of North Carolina, Chapel Hill

调查人员

  • 首席研究员：Abbie Smith-Ryan, PhD、University of North Carolina, Chapel Hill

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 (估计的)

2026年9月8日

初级完成 (估计的)

2027年5月10日

研究完成 (估计的)

2027年5月10日

研究注册日期

首次提交

2026年8月26日

首先提交符合 QC 标准的

2026年8月26日

首次发布 (实际的)

2026年8月31日

研究记录更新

最后更新发布 (实际的)

2026年8月31日

上次提交的符合 QC 标准的更新

2026年8月26日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 26-1724

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Deidentified individual participant data that support the results reported in publications arising from this study will be shared beginning 9 to 36 months following publication, provided that the investigator requesting the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC) at Chapel Hill. When data sharing is permitted, a Data Use Agreement specifying the permitted uses of the shared data must be fully executed before any data are released.

IPD 共享时间框架

Data will be available beginning 9 to 36 months following publication of the primary study results and will remain available for a period determined by UNC data-sharing policies and the terms of the applicable Data Use Agreement.

IPD 共享访问标准

Investigators seeking access to the data must provide documentation of IRB, IEC, or REB approval, where applicable, and enter into a fully executed Data Use Agreement with the University of North Carolina at Chapel Hill prior to receipt of data. Requests will be reviewed by the study investigator and the University in accordance with institutional policies.

IPD 共享支持信息类型

  • 研究方案

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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