Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04097171
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Meena Shah, Texas Christian University

Brief 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 appetite hormones, and cognitive function and mood states.

Condition or disease Intervention/treatment Phase
Endurance Cycling Performance Other: Diet Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Estimated Study Start Date : November 11, 2019
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : March 30, 2021

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.
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.




Primary Outcome Measures :
  1. Endurance Cycling Performance [ Time Frame: 180 min after the meal begins ]
    Time to completion in a 30-kilometer simulated time trial


Secondary Outcome Measures :
  1. 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

  2. Muscle Fuel Rating [ Time Frame: Change from baseline at 180 min and 240 min after the meal begins ]
    Ultrasound echogenicity of Rectus Femoris

  3. 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

  4. 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

  5. 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

  6. 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]

  7. 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

  8. 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

  9. Blood pressure [ Time Frame: Change from baseline at 180 min after the meal begins ]
    Fasted, postprandial & post exercise

  10. Cognitive function [ Time Frame: At 180 min and 240 min after the meal begins ]
    Stroop test

  11. 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"

  12. Resting Metabolic Rate [ Time Frame: At baseline before meal begins ]
    Indirect calorimetry in fasted state

  13. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097171


Contacts
Layout table for location contacts
Contact: Meena Shah, PhD 817-257-6871 m.shah@tcu.edu
Contact: Andreas Kreutzer 817-257-6859 a.kreutzer@tcu.edu

Locations
Layout table for location information
United States, Texas
Texas Christian University Recruiting
Fort Worth, Texas, United States, 76129
Contact: Meena Shah, Ph.D.       m.shah@tcu.edu   
Principal Investigator: Meena Shah, Ph.D.         
Sponsors and Collaborators
Texas Christian University

Layout table for additonal information
Responsible Party: Meena Shah, Interim Chair, Professor and Director, Graduate Program, Texas Christian University
ClinicalTrials.gov Identifier: NCT04097171     History of Changes
Other Study ID Numbers: CT2019MS3
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: Will become available at the latest June 2021 and be available indefinitely
Access Criteria: Openly available
URL: http://osf.io/ujx6e/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No