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临床试验/NCT07122765
NCT07122765已完成不适用

Effect of Caloric Content And Timing of Meal On Postprandial Substrate Oxidation And Pulse Wave Analysis

George Washington University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年11月3日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Pulse Wave Analysis

研究概览

简要总结

The overarching aim of this research is to study the effects of caloric content and timing of meals on measures of postprandial metabolism and cardiovascular response

  1. Determine the effect of caloric content on measures of postprandial metabolic flexibility and pulse wave analysis to a mixed meal challenge.
  2. Determine the effect of meal timing on measures of postprandial metabolic flexibility and pulse wave analysis to a mixed meal challenge.

Hypothesis: 1) that hypercaloric meals will result in significantly reduced indices of metabolic flexibility and pulse wave analysis as compared to eucaloric meals and 2) eucaloric meals consumed later in the day will result in significantly reduced metabolic flexibility and pulse wave analysis as compared to eucaloric meals consumed in the morning.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Males or Females between the ages of 18 and 45 years
  • Low risk for medical complications as determined by physical activity readiness questionnaire (PARQ).
  • Not currently taking antioxidant supplementation, non-steroidal anti-inflammatory drugs (NSAIDS) in a prescribed manner, antibiotics, steroids, or probiotics.
  • Not currently taking any medications for management of cholesterol, diabetes, or body weight/obesity, or are undergoing transgender hormone therapy.
  • Not currently pregnant
  • No history of disordered eating, including anorexia nervosa, bulimia nervosa, binge eating disorder, or avoidant restrictive food intake disorder or screened as high risk for disordered eating via validated questionnaire.
  • No history of gastrointestinal diseases, such as gastroesophageal reflux disease (GERD), irritable bowel syndrome, Celiac disease, Crohn's disease, or lactose intolerance.
  • Considered low risk for food insecurity via the Hunger Vital Sign screener.
  • Cannot have followed a ketogenic diet within the last three months or have been told to avoid a high-fat diet by a medical provider due to cardiovascular disease risk.

排除标准

  • Are currently taking any antioxidant supplementation (daily multivitamin not included), prescribed non-steroidal anti-inflammatory drugs (NSAIDS), antibiotics, steroids, or probiotics.
  • Are currently taking any medications for management of cholesterol, diabetes, or body weight/obesity, or are undergoing hormone therapy (oral contraceptives not included).
  • Are unwilling or unable to comply with study procedures, at the discretion of the investigators.
  • Pregnant women - A urine pregnancy test will be conducted prior to any testing procedures.
  • A history of disordered eating, including anorexia nervosa, bulimia nervosa, binge eating disorder, or avoidant restrictive food intake disorder or deemed high-risk for disordered eating via questionnaire.
  • A history of gastrointestinal diseases, such as gastroesophageal reflux disease (GERD), irritable bowel syndrome (IBS), Celiac disease, Crohn's disease, or lactose intolerance.
  • Deemed high risk for food insecurity via the Hunger Vital Sign screener which is filled out electronically prior to enrollment.
  • Have followed a ketogenic diet within the last three months or have been told to avoid a high-fat diet by a medical provider for risk of cardiovascular disease.

研究组 & 干预措施

Eucaloric Morning Mixed Meal Challenge

Active Comparator

Morning Mixed Meal Challenge (Liquid Shake), 25% of estimated daily caloric need

干预措施: Mixed Meal Feeding Challenge (Other)

Eucaloric Evening Mixed Meal Challenge

Experimental

Evening Mixed Meal Challenge (Liquid Shake), 25% of estimated daily caloric need

干预措施: Mixed Meal Feeding Challenge (Other)

Hypercaloric Morning Mixed Meal Challenge

Experimental

Morning Mixed Meal Challenge (Liquid Shake), 37.5% of estimated daily caloric need

干预措施: Mixed Meal Feeding Challenge (Other)

结局指标

主要结局

Pulse Wave Analysis

时间窗: Baseline to 60 and 120 minutes postprandial

Augmentation Index normalized to 75 beats per minute as index of pulse wave reflection

Postprandial Substrate Oxidation

时间窗: Baseline to 120 minutes postprandial

Respiratory Exchange Ratio

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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