Creatine Monohydrate Supplementation and Vascular Endothelial Health

NCT ID: NCT05014659

Last Updated: 2023-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-17
• Study Completion Date: 2022-12-12

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.

Conditions

Endothelial Dysfunction; Oxidative Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Creatine monohydrate

Participants received 4 x 5g doses of creatine monohydrate (powdered form) for 5 days, followed by 1 x 5g doses of creatine monohydrate (powdered form) for 23 days.

Group Type: EXPERIMENTAL

Creatine monohydrate

Intervention Type: DIETARY_SUPPLEMENT

4 x 5g doses daily for 5 days, followed by 1 x 5g dose daily for 23 days.

Placebo

Participants received 4 x 5g doses of placebo (powdered Maltodextrin) for 5 days, followed by 1 x 5g doses of placebo (powdered Maltodextrin) for 23 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

4 x 5g doses daily for 5 days, followed by 1 x 5g dose daily for 23 days.

Interventions

Creatine monohydrate

4 x 5g doses daily for 5 days, followed by 1 x 5g dose daily for 23 days.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

4 x 5g doses daily for 5 days, followed by 1 x 5g dose daily for 23 days.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Maltodextrin

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Florida State University

OTHER

Sponsor Role: lead

Responsible Party

Holly Clarke

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Holly E Clarke, PhD

Role: PRINCIPAL_INVESTIGATOR

Florida State University

Locations

Sandels Building

Tallahassee, Florida, United States

Countries

United States

Other Identifiers

STUDY00000764

Identifier Type: -

Identifier Source: org_study_id