The Effect of Diet Composition on Performance, Expenditure, Blood Lipids, and Appetite Hormones in Highly Trained Cyclists (DCAP)

October 4, 2021 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76129
        • Texas Christian University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Diet
Participants will consume each diet for 14 days in a crossover design.
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.
Other: Diet
Participants will consume each diet for 14 days in a crossover design.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Endurance Cycling Performance
Time Frame: 180 min after the meal begins
Time to completion in a 30-kilometer simulated time trial
180 min after the meal begins

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Indirect calorimetry fasted, postprandial, and during exercise
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
Ultrasound echogenicity of Rectus Femoris
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
Indirect calorimetry during exercise
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
6-20 Borg's scale during exercise
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
Fasted vs. postprandial indirect calorimetry
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
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]
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
Fasted, postprandial & post exercise blood concentration of appetite hormones
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
Fasted, postprandial & post exercise blood concentration of glucose
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
Fasted, postprandial & post exercise
Change from baseline at 180 min after the meal begins
Cognitive function
Time Frame: At 180 min and 240 min after the meal begins
Stroop test
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
Abbreviated Profile of Mood States; 40-item scale; Likert scale from 0 = "not at all" to 4 = "extremely"
At 180 min and 240 min after the meal begins
Resting Metabolic Rate
Time Frame: At baseline before meal begins
Indirect calorimetry in fasted state
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas Christian University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 11, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 20, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CT2019MS3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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 Sharing Time Frame

Will become available at the latest June 2021 and be available indefinitely

IPD Sharing Access Criteria

Openly available

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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