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

NCT06018480 | Completed

• 1 other identifier: STUDY00003857
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Endothelial Dysfunction

Keywords

Blood Flow; Endothelial Function; Supplementation

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Creatine Monohydrate Supplementation

EXPERIMENTAL

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

Placebo (Maltodextrin)

PLACEBO COMPARATOR

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)

Interventions

Creatine Monohydrate OTHER

The supplementation is the intervention.

Also known as: AlzChem

Creatine Monohydrate Supplementation

Maltodextrin (Placebo) OTHER

Placebo to Creatine Monohydrate

Placebo (Maltodextrin)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Interventions

Creatine; maltodextrin

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Paul Baker, MS

  Florida State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Research Assistant

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 30, 2023
• Study Start: August 29, 2023
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)