跳至主要内容
临床试验/NCT06537401
NCT06537401终止不适用

Adaptations in Postprandial Metabolic Flexibility Following a Three-day, High-fat Diet

George Washington University1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2024年8月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
2
试验地点
1
主要终点
Postprandial Metabolic Flexibility

研究概览

简要总结

The purpose of this study is to understand how the body's response after a meal is influenced by insulin and sugar in the blood. The primary question this study seeks to address is what is the effect of reduced insulin sensitivity on postprandial metabolic flexibility to an oral glucose tolerance test. We will recruit 50 adults (ages 20-45; 50% female) who are otherwise healthy (no known clinical diagnosis) into our non-randomized crossover trial to determine the effect of changes in insulin sensitivity on metabolic response to feeding. Insulin sensitivity will be decreased using a three-day high-fat diet (HFD) with extra calories. Whole-body metabolism will be measured during a standard 75-gram oral glucose tolerance test (OGTT). Metabolic response to feeding (e.g. OGTT) will be compared before and after the HFD and compared with the control diet to understand the effect of decreased insulin sensitivity on the metabolic response to feeding. The role of biological sex as a moderator of the effect of increased insulin resistance on postprandial metabolic flexibility will also be investigated

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • •Males or Females between the ages of 20 and 45 years
  • •Body mass index (BMI) of 18.5-29.9 kg/m2
  • •Low risk for medical complications as determined by physical activity readiness questionnaire (PARQ).
  • •Low risk for food insecurity via the Hunger Vital Sign screener

排除标准

  • •Currently taking any antioxidant supplementation, prescription non-steroidal anti- inflammatory drugs, antibiotics, steroids, probiotics, medications for management of cholesterol, diabetes, body weight/obesity, or are undergoing transgender hormone therapy.
  • •Currently pregnant (verified by urine pregnancy test)
  • •Any history of disordered eating (i.e., anorexia nervosa, bulimia nervosa, binge eating disorder, etc.) or high risk for disordered eating via validated questionnaire (SCOFF)
  • •Any history of gastrointestinal diseases (i.e., gastroesophageal reflux disease, irritable bowel syndrome, Celiac disease, Crohn's disease, or lactose intolerance)
  • •Allergies to wheat or gluten, milk, soy, tree nuts (e.g., almonds, walnuts, pecans), or peanuts.
  • •Followed a ketogenic diet within the last three months
  • •Instructed by a medical provided to avoid a high-fat diet due to cardiovascular disease risk.
  • •Cardiorespiratory fitness (VO2max) greater than the 90th percentile for age and sex

研究组 & 干预措施

Hypercaloric, High Fat Diet

Experimental

For three calendar days participants will be asked to track all foods they eat and beverages they drink (habitual diet) in a mobile application. Following the three days following the habitual diet, participants will consume 165% of their estimated daily energy needs with 65% of those calories coming from fat.

干预措施: Hypercaloric, High Fat Diet (Behavioral)

结局指标

主要结局

Postprandial Metabolic Flexibility

时间窗: 3 Days

Mean difference respiratory exchange ratio during an oral glucose tolerance test following a high fat diet

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

Matthew Barberio

Assistant Professor, Department of Exercise and Nutrition Science

George Washington University

研究点 (1)

Loading locations...

相似试验