Endurance Cycling PerformanceDCAPNCT04097171
The Effect of Diet Composition on Performance, Expenditure, Blood Lipids, and Appetite Hormones in Highly Trained Cyclists
A study testing Diet in people with Endurance Cycling Performance, run by Texas Christian University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Endurance Cycling Performance
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2019to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >100-150km of cycling per week
- VO2max > 80th percentile for sex and age (adjusted for cycle ergometry)
- apparently healthy
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Endurance Cycling Performance
- Being tested
- Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Participants will consume each diet for 14 days in a crossover design.
| Study group | Role | What they receive |
|---|---|---|
| High Carbohydrate Diet | Experimental | Participants will consume a high carbohydrate diet (65-75% of total energy intake). Protein intake will be standardized at 15% of total energy intake. Receives: Other: Diet |
| Ketogenic Diet | Experimental | Participants will consume a low carbohydrate diet (<5-10% of total energy intake). Protein intake will be standardized at 15% of total energy intake. Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endurance Cycling Performance
Time to completion in a 30-kilometer simulated time trial
Measured: 180 min after the meal begins
Secondary outcomes (13)
Respiratory Exchange Ratio
Indirect calorimetry fasted, postprandial, and during exercise
Measured: 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
Ultrasound echogenicity of Rectus Femoris
Measured: Change from baseline at 180 min and 240 min after the meal begins
Oxygen consumption (VO2)
Indirect calorimetry during exercise
Measured: At 192 min, 204 min, 216 min, 228 min and 240 min after the meal begins
Rating of Perceived Exertion (RPE)
6-20 Borg's scale during exercise
Measured: At 192 min, 204 min, 216 min, 228 min and 240 min after the meal begins
Thermic Effect of Food (postprandial energy expenditure)
Fasted vs. postprandial indirect calorimetry
Measured: Change from baseline at 30 min, 60 min, 90 min, 120 min, 150 min, 180 min after the meal begins
Subjective appetite ratings
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]
Measured: Change from baseline at 60 min, 120 min, 180 min after the meal begins
Appetite hormones including ghrelin, leptin, insulin, and Peptide-YY
Fasted, postprandial \& post exercise blood concentration of appetite hormones
Measured: Change from baseline at 30 min, 60 min, 120 min, 180 min and 240 min
Blood glucose
Fasted, postprandial \& post exercise blood concentration of glucose
Measured: Change from baseline at 180 min and 240 min after the meal begins; on day 7 of each diet
Blood pressure
Fasted, postprandial \& post exercise
Measured: Change from baseline at 180 min after the meal begins
Cognitive function
Stroop test
Measured: At 180 min and 240 min after the meal begins
Mood state questionnaire
Abbreviated Profile of Mood States; 40-item scale; Likert scale from 0 = "not at all" to 4 = "extremely"
Measured: At 180 min and 240 min after the meal begins
Resting Metabolic Rate
Indirect calorimetry in fasted state
Measured: At baseline before meal begins
Blood lipids including (triglycerides, total cholesterol, low density lipoprotein, and high-density lipoprotein)
Fasted and postprandial in mg/dL
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start11 Nov 2019
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endurance Cycling PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Christian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meena Shah, Texas Christian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097171
- Sponsor's protocol ID
- CT2019MS3
- Acronym
- DCAP
- Status last verified
- Oct 2021
- First submitted
- 17 Sep 2019
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
Graybeal AJ, Kreutzer A, Moss K, Shah M. Changes in the chronic and postprandial blood lipid profiles of trained competitive cyclists and triathletes following a ketogenic diet: a randomized crossover trial. BMC Sports Sci Med Rehabil. 2024 Jan 16;16(1):19. doi: 10.1186/s13102-023-00801-5.
PubMed 38229197
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Diet Composition on Performance, Energy Expenditure, Blood Lipids and Lipoproteins, and Cognitive Function and Mood States in Highly Trained Cyclists
- ClinicalTrials.gov ID
- NCT04097171
- Acronym / sponsor ID
- DCAP / CT2019MS3
- Conditions
- Endurance Cycling Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Texas Christian UniversityUniversity, hospital or other
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Carbohydrate Diet | Experimental | Other: DietParticipants will consume a high carbohydrate diet (65-75% of total energy intake). Protein intake will be standardized at 15% of total energy intake. |
| Ketogenic Diet | Experimental | Other: DietParticipants will consume a low carbohydrate diet (<5-10% of total energy intake). Protein intake will be standardized at 15% of total energy intake. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >100-150km of cycling per week
- VO2max > 80th percentile for sex and age (adjusted for cycle ergometry)
- apparently healthy
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietParticipants will consume each diet for 14 days in a crossover design. | Other | High Carbohydrate Diet, Ketogenic Diet |
Primary outcome
Endurance Cycling Performance
Time frame: 180 min after the meal begins
Time to completion in a 30-kilometer simulated time trial
13 secondary outcomes
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
Muscle Fuel Rating
Time frame: Change from baseline at 180 min and 240 min after the meal begins
Oxygen consumption (VO2)
Time frame: At 192 min, 204 min, 216 min, 228 min and 240 min after the meal begins
Rating of Perceived Exertion (RPE)
Time frame: At 192 min, 204 min, 216 min, 228 min and 240 min after the meal begins
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
Subjective appetite ratings
Time frame: Change from baseline at 60 min, 120 min, 180 min after the meal begins
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
Blood glucose
Time frame: Change from baseline at 180 min and 240 min after the meal begins; on day 7 of each diet
Blood pressure
Time frame: Change from baseline at 180 min after the meal begins
Cognitive function
Time frame: At 180 min and 240 min after the meal begins
Mood state questionnaire
Time frame: At 180 min and 240 min after the meal begins
Resting Metabolic Rate
Time frame: At baseline before meal begins
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Derived from this study: PubMed 38229197Graybeal AJ, Kreutzer A, Moss K, Shah M. Changes in the chronic and postprandial blood lipid profiles of trained competitive cyclists and triathletes following a ketogenic diet: a randomized crossover trial. BMC Sports Sci Med Rehabil. 2024 Jan 16;16(1):19. doi: 10.1186/s13102-023-00801-5.
- Individual participant dataSharing planned: Yes. 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
Related trials for Endurance Cycling Performance
Recruiting
Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Not yet recruiting
Maple Syrup Carbohydrate Dose-Response on 20-km Cycling Time-Trial Performance
Exercise, Endurance Cycling Performance
Enrolling by invitation
Load and Hold: Impact of 7-Day Creatine Monohydrate Loading on Breath-Hold Cycling Performance
Healthy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Endurance Cycling Performance, run by Texas Christian University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endurance Cycling Performance (time frame: 180 min after the meal begins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04097171, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.