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

May 15, 2024 updated by: Paul Baker, Florida State University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Concentrations of reactive oxygen species (ROS)
Time Frame: Change from pre to post five days of creatine monohydrate supplementation at 0, 1, 2, 3, 4 hours post high carbohydrate meal
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
Time Frame: Change from pre to post five days of creatine monohydrate supplementation at 0, 1, 2, 3, 4 hours post high carbohydrate meal
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
Time Frame: Change from pre to post five days of creatine monohydrate supplementation at 0, 1, 2, 3, 4 hours post high carbohydrate meal
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Florida State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paul Baker, MS, Florida State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 29, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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.

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