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

NCT04097171 | Completed

• 1 other identifier: CT2019MS3
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Endurance Cycling Performance

Outcome Measures

Primary Outcomes (1)

• Endurance Cycling Performance

  Time to completion in a 30-kilometer simulated time trial

  180 min after the meal begins

Secondary Outcomes (13)

• 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

• Muscle Fuel Rating

  Change from baseline at 180 min and 240 min after the meal begins

• Oxygen consumption (VO2)

  At 192 min, 204 min, 216 min, 228 min and 240 min after the meal begins

• Rating of Perceived Exertion (RPE)

  At 192 min, 204 min, 216 min, 228 min and 240 min after the meal begins

• 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

Study Arms (2)

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.

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.

Other: Diet

Interventions

Diet OTHER

Participants will consume each diet for 14 days in a crossover design.

High Carbohydrate Diet; Ketogenic Diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>100-150km of cycling per week
• VO2max \> 80th percentile for sex and age (adjusted for cycle ergometry)
• apparently healthy

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Christian University: lead

Study Sites (1)

Texas Christian University

Fort Worth, Texas, 76129, United States

Location

Related Publications (1)

• 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.

  PMID: 38229197 DERIVED

MeSH Terms

Interventions

Diet

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interim Chair, Professor and Director, Graduate Program

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 20, 2019
• Study Start: November 11, 2019
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: October 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Will become available at the latest June 2021 and be available indefinitely
• Access Criteria: Openly available

Locations

US (1)