NCT07176325已完成不适用
Gastrointestinal and Fluid Retention Symptoms Associated With Creatine Monohydrate With and Without Loading Dose Over 28 Days of Supplementation
Vireo Systems, Inc.1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年5月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Gastrointestinal distress
研究概览
简要总结
This study aimed to investigate the incidence and severity of GI symptoms associated with daily CM supplementation, with and without a loading phase, in healthy male and female adults.
详细描述
In a 28-day single-center, single-blind, randomized clinical trial, 24 healthy participants were assigned to either Group A (5 g/day CM) or Group B (20 g/day loading dose for 14 days followed by 5 g/day maintenance). Blood and urine samples were collected at baseline and day 28 to assess safety. GI symptoms were recorded via self-report using a structured severity rating scale.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •○ Subjects must be healthy males or females, aged 18 to 60 inclusive at the time of screening.
- •Subjects must be able to understand the study, agree to the requirements and restrictions, and be willing to give voluntary consent to participate in the study.
- •Subjects are willing to have up to two (2) blood collections, one at Visit 2 and Visit
- •Subjects are willing to provide a urine sample that is collected over 24 hours. This entails collecting all urine in a 24-hour period in a container.
- •Subject is willing to fast for 12 hours before the Baseline visit (second visit). Water is permitted.
- •Subject is willing to have waist measurements taken with calipers and willing to wear clothing that allows easy access to their waist.
- •Female subjects of childbearing potential must agree to one of the following methods of birth control through the duration of the study. Acceptable methods include: abstinence, same-sex partner, double barrier (condom, diaphragm, or cervical cap with spermicidal foam, gel, or cream); intra-uterine device (IUD) with or without hormones in place or hormonal contraception (oral, injectable, implantable, transdermal, or vaginal) used consecutively for at least 3 month prior to screening visit; vasectomized partner or bilateral insertion of Essure® implants (or analogous) for at least 6 months prior to the screening visit; to be considered a female of non- childbearing potential, subject must have had a bilateral tubal ligation, hysterectomy or bilateral oophorectomy; or postmenopausal status with amenorrhea (no menstruation) for at least 1 year prior to the screening visit.
- •Subject is willing to comply with the study restrictions.
- •Subjects is willing to maintain their current exercise regimen and their current diet while on the study.
排除标准
- •○ Subjects who are participating in another Clinical Trial.
- •Subjects who faint during blood collection, or who have a phobia of needles, or a phobia of blood.
- •Subjects who are weightlifters.
- •Females who are pregnant or lactating (verbal confirmation only).
- •Subject who has taken any creatine supplements in the last 30 days.
- •Subjects with history of cancer (except localized skin cancer without metastases) within 5 years prior to the screening visit.
- •Subject has diabetes (insulin dependent or not) or any immune deficiency disease such as HIV/AIDS, etc.
- •Subject has any medical condition whether treating with mediation or not including hypertension (high blood pressure), hepatitis, any kidney disease or disorders, or musculoskeletal disorders. Note: if there are any significantly abnormal results for the BUN/creatinine screening labs the subject will be dropped.
- •Subject is taking a medication that would preclude participation in the study per the Principal Investigator.
- •Subjects with recent or current medical condition that may significantly impact the subject or the validity of the study results in the opinion of the Investigator.
- •Subjects who have a known or suspected allergy or sensitivity to creatine.
- •Chronic use of NSAIDs (e.g., Ibuprofen, Advil), or use of NSAIDs at one-week prior to each study visit.
结局指标
主要结局
Gastrointestinal distress
时间窗: 28 days
Gastrointestinal effects are well known, particularly at higher doses.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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