- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07579455
Acute Pharmacokinetics of Create Wellness Gummies in Healthy Adults
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Sam R. Moore, PhD
- 전화번호: 4053252542
- 이메일: samray@ou.edu
연구 장소
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Oklahoma
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Norman, Oklahoma, 미국, 73019
- 모병
- ATHENA Laboratory
-
연락하다:
- Sam R. Moore, PhD
- 전화번호: 405-325-2542
- 이메일: samray@ou.edu
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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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실험적: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Peak plasma concentration (Cmax)
기간: 0 to 5-hours following supplementation.
|
Maximum plasma concentration observed.
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0 to 5-hours following supplementation.
|
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Time to peak plasma concentration (Tmax)
기간: 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.
|
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Area under the curve (AUC)
기간: 0 to 5-hours following supplementation.
|
Area under the plasma concentration curve.
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0 to 5-hours following supplementation.
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Sam R Moore, PhD, University of Oklahoma
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 19428
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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