Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2025-12-24 @ 2:38 PM
NCT ID:
NCT05014659
Brief Summary:
To determine the effects of 4 weeks of creatine monohydrate supplementation on markers of macrovascular and microvascular function, cognitive performance, and physical performance.
Detailed Description:
This is a randomized, double-blind (participant and principle investigator), placebo-controlled, crossover study.
After a pre-screen telephone interview, potential participants will be invited to Florida State University for a "Screening visit". During this visit, individuals will be provided with a verbal and written explanation of the study. Individuals will complete an informed consent, a health history questionnaire and physical activity readiness questionnaire. If they meet study inclusion criteria, they will undergo anthropometric measurements and a venous blood draw to determine cardiovascular and kidney disease risk profile. If cleared for participation, participants will be asked to complete a "3-Day Food Log" prior to their next visit.
Once qualified, participants will return to the laboratory to undergo their "Baseline Testing Visit". Following the completion of the first "Baseline Testing Visit", participants will be randomly assigned to one of two interventions: 1) creatine monohydrate; or, 2) maltodextrin "placebo". Participants will be given their supplement and asked to complete the supplementation protocol, complying with instructions given. Following the 4-week supplementation period, participants will return to the laboratory for their "Post-Supplement #1 Testing". During this visit, all procedures from the "Baseline Testing Visit" will be repeated.
Once these measurements are completed, participants will be asked to return to their normal daily lifestyles for a 4-week "wash-out" period. During these 4-weeks, participants will be contacted weekly to ensure retention and to schedule the next visit. Following the washout, participants will return to the laboratory to undergo another "Baseline Testing Visit", completing the exact procedures as outlined previously. Following this, participants will be given their remaining supplement intervention. Following the intervention, participants will return to the lab for their final "Post-Supplement #2 Testing" to conclude the study.
Study:
NCT05014659
Study Brief:
Protocol Section:
NCT05014659