- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01725503
Creatine Kinetics, Synthesis From Glycine and Response to Creatine and Amino Acid Supplement in Healthy Humans
Creatine Metabolism in Humans:Effect of Creatine and Amino Acid Supplement
The goal of the present study is to quantify the rate of synthesis of creatine in healthy controls and endurance trained subjects. In addition, the effect of oral creatine supplement for seven days on creatine kinetics will be examined.
Ten healthy controls (age 20-35 years) and ten endurance trained subjects will be recruited by advertisement. Endurance trained subjects will be recruited from health clubs. They will be screened for absence of any chronic disease (history, physical examination, CBC, metabolic and liver panel, urinalysis). A DEXA measurement will be done to quantify whole body skeletal muscle mass.
For five (5) days prior to the study, they will be placed on a creatine-free (essentially meat-free) diet. Dietary compliance will be ensured by repeated communication with the subject, by nurse coordinator and the CRU Nutritionist. Subject will maintain daily record of the food intake for validation. On the last day, i.e. 24 hours prior to the tracer study, subject will collect the 24 hours urine sample and bring it to the CRU on the day of the study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy controls and endurance trained subjects
- Both males and females will be studied.
Exclusion Criteria:
- any illness
- on any medications and/or supplements
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Creatine and amino acid supplement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quantification of creatine synthesis in healthy subjects
Time Frame: 12/31/2012
|
12/31/2012
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Effect of creatine supplement on the rate of creatine synthesis
Time Frame: 12/31/2012
|
12/31/2012
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Satish Kalhan, MD, The Cleveland Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 10-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Creatine Synthesis in Healthy Subjects
-
Vrije Universiteit BrusselCompletedHealthy | Creatine SupplementationBelgium
-
WockhardtWithdrawnBioequivalence in Healthy SubjectsUnited States
-
Baystate Medical CenterCompleted
-
WockhardtWithdrawnBioequivalence in Healthy SubjectsUnited States
-
WockhardtWithdrawnBioequivalence in Healthy SubjectsUnited States
-
Impax Laboratories, LLCCompletedCardiac Repolarization in Healthy SubjectsUnited States
-
University of FloridaNational Institute of Allergy and Infectious Diseases (NIAID)WithdrawnMicrobiota Analysis in Healthy SubjectsUnited States
-
Nabriva Therapeutics AGCompletedCardiac Repolarization in Healthy SubjectsUnited States
-
The University of Texas at DallasCompletedAssociative Memory in Healthy SubjectsUnited States
-
Mylan Inc.Theravance BiopharmaCompletedCardiac Repolarization in Healthy SubjectsUnited States
Clinical Trials on Creatine and Amino Acid supplement
-
The University of Texas Health Science Center at...National Center for Advancing Translational Sciences (NCATS); IIMS-UT Health...Not yet recruiting
-
Abbott NutritionCompleted
-
University of Alabama at BirminghamAbbott NutritionCompletedObesity | Post-gastric BypassUnited States
-
University of UtahNational Cancer Institute (NCI)RecruitingFatigue | Sedentary Lifestyle | Metastatic Prostate Carcinoma | Stage IV Prostate Cancer AJCC (American Joint Committee on Cancer) v8 | Stage IVA Prostate Cancer AJCC (American Joint Committee on Cancer) v8 | Stage IVB Prostate Cancer AJCC (American Joint Committee on Cancer) v8United States
-
Wageningen UniversityRecruiting
-
University of Colorado, DenverCompletedObesity | Polycystic Ovarian Syndrome | Hepatic SteatosisUnited States
-
University of VermontCompletedExercise-induced Delayed Onset Muscle SorenessUnited States
-
ZandA Technologies, llcKGK Science Inc.CompletedHealthy | Insulin-Like Growth Factor ICanada
-
University of North Carolina, Chapel HillNational Strength and Conditioning FoundationCompletedObesity | Cardiovascular Risk FactorUnited States
-
Universitaire Ziekenhuizen KU LeuvenRecruiting