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

Sponsor

Texas Christian University (Other)

Overall Status

Completed

CT.gov ID

NCT04097171

Collaborator

(none)

Enrollment

Location

Arms

4.6

Actual Duration (Months)

7.4

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Actual Enrollment :

34 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

Actual Study Start Date :

Nov 11, 2019

Actual Primary Completion Date :

Mar 30, 2020

Actual Study Completion Date :

Mar 30, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Endurance Cycling Performance [180 min after the meal begins]
Time to completion in a 30-kilometer simulated time trial

Secondary Outcome Measures

Respiratory Exchange Ratio [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 [Change from baseline at 180 min and 240 min after the meal begins]
Ultrasound echogenicity of Rectus Femoris
Oxygen consumption (VO2) [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) [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) [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 [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 [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 [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 [Change from baseline at 180 min after the meal begins]
Fasted, postprandial & post exercise
Cognitive function [At 180 min and 240 min after the meal begins]
Stroop test
Mood state questionnaire [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 [At baseline before meal begins]
Indirect calorimetry in fasted state
Blood lipids including (triglycerides, total cholesterol, low density lipoprotein, and high-density lipoprotein) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Texas Christian University	Fort Worth	Texas	United States	76129

Sponsors and Collaborators

Texas Christian University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Meena Shah, Interim Chair, Professor and Director, Graduate Program, Texas Christian University

ClinicalTrials.gov Identifier:

NCT04097171

Other Study ID Numbers:

CT2019MS3

First Posted:

Sep 20, 2019

Last Update Posted:

Oct 5, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 5, 2021