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Completed

NCT Number: NCT06018480

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

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).

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University

Tallahassee, Florida, 32306, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Creatine Monohydrate

Other

The supplementation is the intervention.

Other names: AlzChem

Maltodextrin (Placebo)

Other

Placebo to Creatine Monohydrate

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Official study title

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

Acronym: NOXCROS

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 30, 2023
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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