Protective Effect of Exercise on Acute High-fat Overfeeding (HFDEXC)
2026年6月4日 更新者:Matthew Barberio、George Washington University
Metabolic flexibility is the ability to switch rapidly from one substrate (i.e.
fuel source) to another (e.g.
fats to carbohydrates) in response to ingested foods.
Worse metabolic flexibility is linked to worse metabolic outcomes, but exercise is thought to be protective against nutrient excess.
We will conduct a standard oral glucose tolerance test (OGTT) to assess insulin resistance and metabolic flexibility.
Participants will be randomized to a 24-hour hypercaloric, high-fat diet (HFD) with and without an exercise bout.
During the hypercaloric HFD, participants will eat extra calories with more calories from fat than normal, which is expected to increase insulin resistance.
After each arm of the high-fat diet, we will repeat the OGTT.
During each OGTT, expired gases will be analyzed noninvasively to determine metablic flexibility.
Insulin resistance will be determined with blood drawn during each OGTT.
By comparing metabolic flexiblity and insulin resistance before and after the normal diet and after the high-fat diet intervention, a better understanding of how insulin resistance affects metabolism and how exercise can be protective will be developed.
研究概览
研究类型
介入性
注册 (实际的)
50
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
District of Columbia
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Washington D.C.、District of Columbia、美国、20052
- Milken Institute School of Public Health
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
Inclusion Criteria:
- Males or females between the ages of 20 and 40 years
- A body mass index (BMI) of 20.0 - 29.9 kg/m2.
- Low risk for risk of injury or health complications as determined by physical activity readiness questionnaire (PARQ).
Exclusion Criteria:
- 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.
- Are unwilling or unable to comply with study procedures, at the discretion of the investigators.
- Are unwilling to have biospecimens (blood and urine) collected and stored (only blood) for future research.
- 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 galactosemia, gastroesophageal reflux disease (GERD), irritable bowel syndrome (IBS), Celiac disease, Crohn's disease, or lactose intolerance.
- Individuals with known allergies to wheat or gluten, milk, soy, tree nuts (e.g., almonds, walnuts, pecans), or peanuts.
- Deemed high risk for food insecurity via the Hunger Vital Sign screener.
- 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.
- Cardiorespiratory fitness (VO2max) below the 30th percentile for age and sex (measured at initial screening visit)
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:High Fat Overfeeding
Resting metabolic rate will be used estimate total caloric need.
We will use this estimate to create a daily target calorie intake and target fat intake for the High-Fat Diets (HFD) in the study.
During the high-fat diet, subjects will eat 80% more calories than necessary with at least 65% of the calories coming from fat for one day.
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Caloric intake 180% of daily caloric need with 65% from fat
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实验性的:High Fat Overfeeding + Exercise
On the day of High Fat Overfeeding (See High Fat Overfeeding arm description), subjects will complete a single bout of exercise.
The duration of exercise will be individualized to ~25% of daily energy needs.The intensity of exercise will be individualized to be at a low intensity in the moderate domain.
Extra foods will be provided to match energy balance across the high-fat overfeeding days
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Caloric intake 180% of daily caloric need with 65% from fat with acute moderate exercise (energy expenditure ~25% of daily caloric need).
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Insulin Sensitivity via Oral Glucose Insulin Sensitivity Index
大体时间:Immediately following high fat diet intervention
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Oral Glucose Insulin Sensitivity
|
Immediately following high fat diet intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Metabolic Flexibility (Respiratory Exchange Ratio) via Indirect Calorimetry
大体时间:Immediately following high fat diet intervention
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Respiratory Exchange Ratio, Glucose Oxidation, Fatty Acid Oxidation
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Immediately following high fat diet intervention
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Carotid Femoral Pulse Wave velocity
大体时间:Immediately following high fat diet intervention
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Carotid Femoral Pulse Wave Velcoity
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Immediately following high fat diet intervention
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Matthew Barberio、George Washington University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年2月10日
初级完成 (实际的)
2026年4月7日
研究完成 (实际的)
2026年4月9日
研究注册日期
首次提交
2026年5月11日
首先提交符合 QC 标准的
2026年6月4日
首次发布 (实际的)
2026年6月8日
研究记录更新
最后更新发布 (实际的)
2026年6月8日
上次提交的符合 QC 标准的更新
2026年6月4日
最后验证
2026年4月1日
更多信息
与本研究相关的术语
其他研究编号
- NCR246197
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
是的
IPD 计划说明
Individual data will be annonymized by study ID number and removed of any identifying information.
Data will be shared upon reasonable request.
IPD 共享时间框架
Upon publication, data will be shared upon reasonable request to the corresponding author.
IPD 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
- 分析代码
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.