The Effect of Diet Composition on Performance, Expenditure, Blood Lipids, and Appetite Hormones in Highly Trained Cyclists (DCAP)
2021年10月4日 更新者：Meena Shah、Texas Christian University
The Effect of Diet Composition on Performance, Energy Expenditure, Blood Lipids and Lipoproteins, and Cognitive Function and Mood States in Highly Trained Cyclists
This study employs a crossover design to evaluate the effect of two different diets (high carbohydrate vs. ketogenic) and corresponding test meals on endurance exercise performance, energy expenditure including resting metabolic rate and thermic effect of food, postprandial responses of blood lipids, glucose and appetite hormones, and cognitive function and mood states.
研究概览
详细说明
Traditionally, a high carbohydrate diet is recommended for elite endurance athletes and sub-elite, highly trained recreational athletes competing in endurance events. However, recently the ketogenic diet (extremely low carbohydrate content) has become popular in these populations. The effect on endurance exercise performance, energy expenditure, postprandial blood profiles, and cognitive function and mood states requires further investigation.
In this study, highly trained recreational cyclists and triathletes will adhere to each diet (high-carbohydrate and ketogenic) for 14 days in a crossover design. Experimental trials at baseline and after each diet will evaluate endurance cycling performance (time trial), resting energy expenditure, the thermic effect of food of test meals corresponding in composition to each diet, postprandial responses of blood lipids, glucose and appetite hormones, and cognitive function and mood states.
研究类型
介入性
注册 (实际的)
34
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
-
-
Texas
-
Fort Worth、Texas、美国、76129
- Texas Christian University
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-
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
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- >100-150km of cycling per week
- VO2max > 80th percentile for sex and age (adjusted for cycle ergometry)
- apparently healthy
Exclusion Criteria:
- weight loss supplements/medications/diet
- extreme dietary patterns (e.g. extremely high or low carbohydrate)
- nicotine use
- heavy alcohol use (>7 drinks/week female; >14 drinks/week male)
- food allergies
- diabetes
- heart disease
- stroke
- liver/kidney/thyroid disease
- anemia
- eating disorders
- uncontrolled hypertension
- pulmonary/orthopedic/musculoskeletal problems that prevent exercise
- surgery that affects swallowing and digestion
- claustrophobia
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 Carbohydrate Diet
Participants will consume a high carbohydrate diet (65-75% of total energy intake).
Protein intake will be standardized at 15% of total energy intake.
|
Participants will consume each diet for 14 days in a crossover design.
|
|
实验性的：Ketogenic Diet
Participants will consume a low carbohydrate diet (<5-10% of total energy intake).
Protein intake will be standardized at 15% of total energy intake.
|
Participants will consume each diet for 14 days in a crossover design.
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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 |
|---|---|---|
|
Endurance Cycling Performance
大体时间：180 min after the meal begins
|
Time to completion in a 30-kilometer simulated time trial
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180 min after the meal begins
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Respiratory Exchange Ratio
大体时间：Change from baseline at 30 min, 60 min, 90 min, 120 min, 150 min, 180 min, 192 min, 204 min, 216 min, 228 min and 240 min after the meal begins
|
Indirect calorimetry fasted, postprandial, and during exercise
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Change from baseline at 30 min, 60 min, 90 min, 120 min, 150 min, 180 min, 192 min, 204 min, 216 min, 228 min and 240 min after the meal begins
|
|
Muscle Fuel Rating
大体时间：Change from baseline at 180 min and 240 min after the meal begins
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Ultrasound echogenicity of Rectus Femoris
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Change from baseline at 180 min and 240 min after the meal begins
|
|
Oxygen consumption (VO2)
大体时间：At 192 min, 204 min, 216 min, 228 min and 240 min after the meal begins
|
Indirect calorimetry during exercise
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At 192 min, 204 min, 216 min, 228 min and 240 min after the meal begins
|
|
Rating of Perceived Exertion (RPE)
大体时间：At 192 min, 204 min, 216 min, 228 min and 240 min after the meal begins
|
6-20 Borg's scale during exercise
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At 192 min, 204 min, 216 min, 228 min and 240 min after the meal begins
|
|
Thermic Effect of Food (postprandial energy expenditure)
大体时间：Change from baseline at 30 min, 60 min, 90 min, 120 min, 150 min, 180 min after the meal begins
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Fasted vs. postprandial indirect calorimetry
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Change from baseline at 30 min, 60 min, 90 min, 120 min, 150 min, 180 min after the meal begins
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Subjective appetite ratings
大体时间：Change from baseline at 60 min, 120 min, 180 min after the meal begins
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Visual Analog Scale (Scale 1: Perception of Hunger [0-100 mm]; Scale 2: Perception of Fullness [0-100 mm]; Scale 3: Desire to Eat [0-100 mm]
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Change from baseline at 60 min, 120 min, 180 min after the meal begins
|
|
Appetite hormones including ghrelin, leptin, insulin, and Peptide-YY
大体时间：Change from baseline at 30 min, 60 min, 120 min, 180 min and 240 min
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Fasted, postprandial & post exercise blood concentration of appetite hormones
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Change from baseline at 30 min, 60 min, 120 min, 180 min and 240 min
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Blood glucose
大体时间：Change from baseline at 180 min and 240 min after the meal begins; on day 7 of each diet
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Fasted, postprandial & post exercise blood concentration of glucose
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Change from baseline at 180 min and 240 min after the meal begins; on day 7 of each diet
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Blood pressure
大体时间：Change from baseline at 180 min after the meal begins
|
Fasted, postprandial & post exercise
|
Change from baseline at 180 min after the meal begins
|
|
Cognitive function
大体时间：At 180 min and 240 min after the meal begins
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Stroop test
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At 180 min and 240 min after the meal begins
|
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Mood state questionnaire
大体时间：At 180 min and 240 min after the meal begins
|
Abbreviated Profile of Mood States; 40-item scale; Likert scale from 0 = "not at all" to 4 = "extremely"
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At 180 min and 240 min after the meal begins
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Resting Metabolic Rate
大体时间：At baseline before meal begins
|
Indirect calorimetry in fasted state
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At baseline before meal begins
|
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Blood lipids including (triglycerides, total cholesterol, low density lipoprotein, and high-density lipoprotein)
大体时间：Change from baseline at 30 min, 60 min, 120 min, 180 min, 192 min, 204 min, 216 min, 228 min and 240 min after the meal begins
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Fasted and postprandial in mg/dL
|
Change from baseline at 30 min, 60 min, 120 min, 180 min, 192 min, 204 min, 216 min, 228 min and 240 min after the meal begins
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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。
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)
2019年11月11日
初级完成 (实际的)
2020年3月30日
研究完成 (实际的)
2020年3月30日
研究注册日期
首次提交
2019年9月17日
首先提交符合 QC 标准的
2019年9月18日
首次发布 (实际的)
2019年9月20日
研究记录更新
最后更新发布 (实际的)
2021年10月5日
上次提交的符合 QC 标准的更新
2021年10月4日
最后验证
2021年10月1日
更多信息
与本研究相关的术语
其他研究编号
- CT2019MS3
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
De-identified study data of all outcome variables will be shared on an Open Science Framework project page (osf.io)
along with the study protocol, statistical analysis plan, and analytic code
IPD 共享时间框架
Will become available at the latest June 2021 and be available indefinitely
IPD 共享访问标准
Openly available
IPD 共享支持信息类型
- 研究协议
- 统计分析计划 (SAP)
- 解析代码
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
在美国制造并从美国出口的产品
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.