Clinical trial NCT05014659: Creatine Monohydrate Supplementation and Vascular Endothelial Health
Official title: The Impact of Creatine Supplementation on Vascular Endothelial Function, Blood Flow and Functional Exercise Capacity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Dysfunction
Oxidative Stress
Keywords: Older adults
Flow mediated dilation
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* both male and female
* 50-64 years old
* no restrictions based on race, ethnicity, or socioeconomic status
* sedentary individuals (\<20 minutes; \<3 days/wk. physical activity)
* post-menopausal women (has experienced 12 consecutive months without menstruation for \>5 years).

Exclusion Criteria:

* \<50 or ≥65 years of age
* Subjects participating in regular exercise (\>20 min/day, \>3 days/week)
* female subjects who are pregnant, lactating or 1 month post-partum
* currently consuming or had consumed creatine supplementation \<1 month prior to screening
* currently consuming or consumed nitric oxide supplementation \<1 month prior to screening
* currently consuming or had consumed Vitamin C supplementation \<2 weeks prior to screening
* individuals who report chronic infections
* individuals reporting paralysis due to stroke
* individuals reporting advanced Parkinson's disease
* individuals reporting severe rheumatoid arthritis or other serious orthopedic problems that would prevent performance of the exercise tasks
* individuals currently taking medications that may affect central or peripheral circulation
* individuals with known cardiovascular and/or metabolic disease
* current smokers or those who quit \<6 months prior to screening
* individuals with hypercholesterolemia (total cholesterol \> 200mg/dL, high density lipoprotein \<40 mg/dL, low density lipoprotein \>130mg/dL)
* individuals with hypertension (systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \>95mmHg).
* individuals with known kidney disease
* individuals with known liver disease

Primary outcomes:
measure: Change from baseline in brachial artery flow mediated dilation (FMD%) at week 4
timeFrame: Baseline and Week 4
measure: Change from baseline in forearm microvascular reperfusion rate (%/sec) at week 4
timeFrame: Baseline and Week 4
measure: Change from baseline in brachial-ankle pulse wave velocity (baPWV) at week 4
timeFrame: Baseline and Week 4
measure: Change from baseline in augmentation (AUG) and augmentation index (AIx) using pulse wave analysis (PWA) at week 4
timeFrame: Baseline and Week 4
measure: Change from baseline in oxidized low density lipoprotein (oxLDL) at week 4
timeFrame: Baseline and Week 4
measure: Change from baseline in tetrahydrobiopterin (BH4) at week 4
timeFrame: Baseline and Week 4
measure: Change from baseline in malondialdehyde (MDA) at week 4
timeFrame: Baseline and Week 4
measure: Change from baseline in total 6-minute walking distance (6MWT) at week 4
timeFrame: Baseline and Week 4
measure: Change from baseline in total torque produced (total Nm) per set at week 4
timeFrame: Baseline and Week 4
measure: Change from baseline in time taken to complete (seconds) the Trail Making Test (TMT) at Week 4
timeFrame: Baseline and Week 4
measure: Change from baseline in maximum number recall (#) achieved in the Digit Span memory recall test at Week 4
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: Change from baseline in body fat percent (BF%) at week 4
timeFrame: Baseline and Week 4
measure: Change from baseline in body lean mass (grams) at week 4
timeFrame: Baseline and Week 4
measure: Change from baseline in body fat mass (grams) at week 4
timeFrame: Baseline and Week 4
measure: Change from baseline in total body water (liters) at week 4
timeFrame: Baseline and Week 4
measure: Change from baseline in resting systolic blood pressure (mmHg) at week 4
timeFrame: Baseline and Week 4
measure: Change from baseline in resting diastolic blood pressure (mmHg) at week 4
timeFrame: Baseline and Week 4
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Sandels Building
state: Florida
Study officials:
affiliation: Florida State University
name: Holly E Clarke, PhD
role: PRINCIPAL_INVESTIGATOR
References: