The Effect of NADPH Oxidase and Creatine Supplementation on Microvascular Blood Flow Regulation (NOXCROS)

NADPH Oxidase Affects on Blood Flow After Administering a High Carbohydrate Meal Pre- and Post-creatine Monohydrate Supplementation.

This research study seeks to determine the effects of an enzyme in the human body called NADPH oxidase (NOX) on blood flow. In addition, the study will investigate the benefits of creatine monohydrate, a common sports performance supplement, on blood food and vessel function. Participants will undergo two study arms, one in which they consume a high carbohydrate meal pre- and post-creatine monohydrate supplementation and one in which they will consume a high carbohydrate meal pre- and post-placebo supplementation. Blood flow and endothelial function will be assessed before and for 4 hours following the consumption of a high-carbohydrate meal pre and post-supplementation (creatine monohydrate and placebo).

Study Overview

• Status: Completed
• Conditions: Endothelial Dysfunction
• Intervention / Treatment: Other: Creatine Monohydrate; Other: Maltodextrin (Placebo)

Detailed Description

A double-blind cross-over placebo-controlled study design will be used to determine the extent to which NOX and creatine monohydrate supplementation influences skeletal muscle microvascular blood flow and endothelial function following the administration of a high carbohydrate meal in sedentary individuals with overweight/obesity. Participants will be initially screened through a telephone screening over the phone or through an electronic copy (Qualtrics survey) and upon meeting the inclusion criteria, will be scheduled for a baseline visit. At the baseline visits participants will go through an informed consent, background and medical history questionnaire alongside a Dual-energy X-ray absorptiometry (DXA) scan and indirect calorimetry. Subsequently, participants will undergo two main testing days, one will occur before supplementation (creatine monohydrate or placebo) and the other following five days of supplementation (creatine monohydrate or placebo). At the main testing days participants will have their resting blood flow and endothelial function assessed before and for 4 hours following the consumption of a high carbohydrate meal. Following the two main testing days in the first study arm, participants will then undergo a 4-week wash-out in which they will resume their normal behavior and stop taking the supplement they were provided. After the washout period, participants will come back and repeat the baseline visit and the two main testing days. The only difference is that participants will receive the other treatment that was not received the first time (creatine monohydrate or placebo). Which treatment the participant receives first or second will be at random.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32306
      • Florida State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Body Mass Index: 25.0-34.9 kg/m2
• Sedentary; sedentary status will be defined as not performing purposeful exercise training more than 20 minutes per day three a week.
• Currently residing in Tallahassee, Florida, or the surrounding area
• Not taking any medication(s) that interfere with metabolism.
• Not taking any antioxidant supplementation, at least four weeks before the study.
• Not supplementing with creatine monohydrate, at least four weeks before the study.
• Not smoking, vaping, or chewing tobacco and willing to refrain from smoking, vaping, and chewing tobacco throughout the entire study.
• Are not pregnant or planning on becoming pregnant

Exclusion Criteria:

• Metabolic or cardiovascular abnormalities, gastrointestinal disorders, and any condition that interferes with metabolism or oxygen delivery/transport including:

  • Diagnosed cardiovascular diseases or previous myocardial infarction.
  • Uncontrolled hypertension (resting: above 140 mmHg systolic or 90 mmHg diastolic)
  • Diabetes (Type 1 or 2)
  • Uncontrolled thyroid conditions
• Cigarette smoking: current cigarette smoker or those who quit within the previous 6 months.
• Participants consuming supplements or medication known to impact metabolism.
• Participants already consuming creatine monohydrate
• Allergies or intolerance to foods included in the standardized and high carbohydrate meal.
• Women that are pregnant or planning on becoming pregnant
• Weight gain or loss > 10% of body weight during the past 6 months
• Participants consume a vegan or vegetarian diet.
• Non-English-speaking individuals, infants, children, teenagers, cognitively impaired adults individuals, and adults who are unable to consent will be recruited for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Creatine Monohydrate Supplementation; Participants will be provided with 20 grams of creatine monohydrate per day (100 grams total) in sealed and unopened packages (5 grams in each package). Participants will be asked to complete their supplementation protocol (20 grams/day) by mixing 5 grams of creatine monohydrate powder into water 4 times a day or 10 grams of creatine monohydrate powder into water twice a day. This supplementation will occur after a baseline visit in which participants consume a high-carb meal and have their vascular function studied before the meal and four hours post-prandial. Following the 5 days of supplementation participants will come back and consume a high-carb meal and have their vascular function studied before the meal and four hours post-prandial.	Other: Creatine Monohydrate; The supplementation is the intervention.; Other Names: AlzChem
Placebo Comparator: Placebo (Maltodextrin); Participants will be provided with 20 grams of maltodextrin (placebo) per day (100 grams total) in sealed and unopened packages (5 grams in each package). Participants will be asked to complete their supplementation protocol (20 grams/day) by mixing 5 grams of maltodextrin (placebo) into water 4 times a day or 10 grams of maltodextrin (placebo) powder into water twice a day. This supplementation will occur after a baseline visit in which participants consume a high-carb meal and have their vascular function studied before the meal and four hours post-prandial. Following the 5 days of supplementation participants will come back and consume a high-carb meal and have their vascular function studied before the meal and four hours post-prandial.	Other: Maltodextrin (Placebo); Placebo to Creatine Monohydrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentrations of reactive oxygen species (ROS)	Reactive oxygen species measured with microdialysis, reported as hydrogen peroxide (H2O2) concentrations.	Change from pre to post five days of creatine monohydrate supplementation at 0, 1, 2, 3, 4 hours post high carbohydrate meal
Rate of skeletal muscle blood flow	Skeletal muscle microvascular blood flow measured with microdialysis reported as ethanol outflow/inflow ratio which is inversely with blood flow.	Change from pre to post five days of creatine monohydrate supplementation at 0, 1, 2, 3, 4 hours post high carbohydrate meal
Flow mediated dilation percentage	Endothelial function as measured with brachial artery flow-mediated dilation, reported as a percentage.	Change from pre to post five days of creatine monohydrate supplementation at 0, 1, 2, 3, 4 hours post high carbohydrate meal

Collaborators and Investigators

• Sponsor: Florida State University
• Investigators: Principal Investigator: Paul Baker, MS, Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2023
• Primary Completion (Actual): January 30, 2024
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: August 25, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Supplementation; Endothelial Function; Blood Flow
• Other Study ID Numbers: STUDY00003857

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No