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

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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

Tracking Information
First Submitted Date  ICMJE September 17, 2019
First Posted Date  ICMJE September 20, 2019
Last Update Posted Date November 6, 2019
Estimated Study Start Date  ICMJE November 11, 2019
Estimated Primary Completion Date March 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2019)
Endurance Cycling Performance [ Time Frame: 180 min after the meal begins ]
Time to completion in a 30-kilometer simulated time trial
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04097171 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
  • 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
  • Muscle Fuel Rating [ Time Frame: Change from baseline at 180 min and 240 min after the meal begins ]
    Ultrasound echogenicity of Rectus Femoris
  • 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
  • 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
  • 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
  • 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]
  • 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
  • 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
  • Blood pressure [ Time Frame: Change from baseline at 180 min after the meal begins ]
    Fasted, postprandial & post exercise
  • Cognitive function [ Time Frame: At 180 min and 240 min after the meal begins ]
    Stroop test
  • 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"
  • Resting Metabolic Rate [ Time Frame: At baseline before meal begins ]
    Indirect calorimetry in fasted state
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2019)
  • 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
  • Muscle Fuel Rating [ Time Frame: Change from baseline at 180 min and 240 min after the meal begins ]
    Ultrasound echogenicity of Rectus Femoris
  • 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
  • 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
  • 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
  • Subjective appetite ratings [ Time Frame: Change from baseline at 60 min, 120 min, 180 min after the meal begins ]
    Visual Analog Scale (Hunger & Fullness)
  • Appetite hormones including ghrelin, leptin, 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
  • 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
  • Blood pressure [ Time Frame: Change from baseline at 180 min after the meal begins ]
    Fasted, postprandial & post exercise
  • Cognitive function [ Time Frame: At 180 min and 240 min after the meal begins ]
    Stroop test
  • Mood state questionnaire [ Time Frame: At 180 min and 240 min after the meal begins ]
    Abbreviated profile of mood states questionnaire
  • Resting Metabolic Rate [ Time Frame: At baseline before meal begins ]
    Indirect calorimetry in fasted state
  • Blood lipids including triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, total cholesterol, and lipoprotein particle sizes. [ 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 blood lipid profile
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Diet Composition on Performance, Expenditure, Blood Lipids, and Appetite Hormones in Highly Trained Cyclists
Official Title  ICMJE The Effect of Diet Composition on Performance, Energy Expenditure, Blood Lipids and Lipoproteins, and Cognitive Function and Mood States in Highly Trained Cyclists
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Endurance Cycling Performance
Intervention  ICMJE Other: Diet
Participants will consume each diet for 14 days in a crossover design.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Diet
  • 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.
    Intervention: Other: Diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 4, 2019)
20
Original Estimated Enrollment  ICMJE
 (submitted: September 18, 2019)
16
Estimated Study Completion Date  ICMJE March 30, 2021
Estimated Primary Completion Date March 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Meena Shah, PhD 817-257-6871 m.shah@tcu.edu
Contact: Andreas Kreutzer 817-257-6859 a.kreutzer@tcu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04097171
Other Study ID Numbers  ICMJE CT2019MS3
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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/
Responsible Party Meena Shah, Texas Christian University
Study Sponsor  ICMJE Texas Christian University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Texas Christian University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP