- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04097171
The Effect of Diet Composition on Performance, Expenditure, Blood Lipids, and Appetite Hormones in Highly Trained Cyclists (DCAP)
The Effect of Diet Composition on Performance, Energy Expenditure, Blood Lipids and Lipoproteins, and Cognitive Function and Mood States in Highly Trained Cyclists
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Fort Worth, Texas, United States, 76129
- Texas Christian University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
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Participants will consume each diet for 14 days in a crossover design.
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Experimental: 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.
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Participants will consume each diet for 14 days in a crossover design.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Endurance Cycling Performance
Time Frame: 180 min after the meal begins
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Time to completion in a 30-kilometer simulated time trial
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180 min after the meal begins
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Respiratory Exchange Ratio
Time Frame: 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
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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
Time Frame: 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
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|
Oxygen consumption (VO2)
Time Frame: At 192 min, 204 min, 216 min, 228 min and 240 min after the meal begins
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Indirect calorimetry during exercise
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At 192 min, 204 min, 216 min, 228 min and 240 min after the meal begins
|
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Rating of Perceived Exertion (RPE)
Time Frame: At 192 min, 204 min, 216 min, 228 min and 240 min after the meal begins
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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
|
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Thermic Effect of Food (postprandial energy expenditure)
Time Frame: 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
Time Frame: 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
|
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Appetite hormones including ghrelin, leptin, insulin, and Peptide-YY
Time Frame: 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
Time Frame: 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
Time Frame: Change from baseline at 180 min after the meal begins
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Fasted, postprandial & post exercise
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Change from baseline at 180 min after the meal begins
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Cognitive function
Time Frame: 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
Time Frame: At 180 min and 240 min after the meal begins
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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
Time Frame: At baseline before meal begins
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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)
Time Frame: 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
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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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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CT2019MS3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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