跳至主要内容
临床试验/NCT06018480
NCT06018480已完成不适用

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

Florida State University2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2023年8月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
2
主要终点
Rate of skeletal muscle blood flow

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Rate of skeletal muscle blood flow

时间窗: 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.

Flow mediated dilation percentage

时间窗: 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.

Concentrations of reactive oxygen species (ROS)

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul Baker

Graduate Research Assistant

Florida State University

研究点 (2)

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