Determining the Ergogenic Effects of Carb10™ Supplementation on Carbohydrate-Rich and Carbohydrate-Restricted Diets

NCT03231514 | Completed

• 1 other identifier: 19151
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

The study will examine the performance and body composition effects of ketogenic vs carbohydrate-based diets, determine the carbohydrate tolerance ("carbohydrate threshold") for active individuals on a ketogenic diet, and then, reexamine the performance and body composition effects when the diets are modified with supplemental carbohydrate up to the newly defined "ketogenic threshold."

Conditions

Ketogenic Dieting

Keywords

body composition; exercise performance; keto-adaptation

Outcome Measures

Primary Outcomes (2)

• Change in Body Composition

  Will be measured as fat and lean soft tissue mass in kg by dual x-ray absorptiometry (DXA)

  0 and 10 weeks

• Change in Anaerobic Cardiovascular Performance

  Will be measured as peak and average power output in Watts during a repeated Wingate sprint test

  0 and 10 weeks

Secondary Outcomes (29)

• Change in Body Composition

  0 and 10 weeks

• Change in Body Water

  0 and 10 weeks

• Change in Cross-sectional Area

  0 and 10 weeks

• Change in Muscle Thickness

  0 and 10 weeks

• Change in Aerobic Performance

  0 and 10 weeks

Study Arms (4)

Carbohydrate Diet & Placebo & Exercise

PLACEBO COMPARATOR

This group receives the carbohydrate-based diet and flavored placebo pre-workout drink. All participate in the exercise intervention.

Other: Exercise

Carbohydrate Diet & Carbohydrate Supplement(Carb10) & Exercise

ACTIVE COMPARATOR

This group receives the carbohydrate-based diet and supplemental carbohydrate. Will be compared to Carbohydrate \& Placebo for effects of supplement. All participate in the exercise intervention.

Dietary Supplement: Carbohydrate Supplement (Carb10); Other: Exercise

Ketogenic Diet & Placebo & Exercise

EXPERIMENTAL

This group receives the ketogenic diet and flavored placebo. It is both an experimental (vs. carbohydrate diet \& placebo) and placebo control group (vs. ketogenic \& supplement). All participate in the exercise intervention.

Other: Diet; Other: Exercise

Ketogenic Diet & Carbohydrate Supplement (Carb10) & Exercise

EXPERIMENTAL

This group receives the ketogenic diet and supplemental carbohydrate. All participate in the exercise intervention.

Dietary Supplement: Carbohydrate Supplement (Carb10); Other: Diet; Other: Exercise

Interventions

Carbohydrate Supplement (Carb10) DIETARY_SUPPLEMENT

2 of 4 arms will be supplemented with carbohydrate pre-workout (Carb10, Compound Solutions, Carlsbad, CA)

Carbohydrate Diet & Carbohydrate Supplement(Carb10) & Exercise; Ketogenic Diet & Carbohydrate Supplement (Carb10) & Exercise

Diet OTHER

2 groups will be on a carbohydrate-based diet (% energy from carbohydrate:fat:protein, 53:24:23) and 2 groups will be on a ketogenic diet (72:5:23)

Ketogenic Diet & Carbohydrate Supplement (Carb10) & Exercise; Ketogenic Diet & Placebo & Exercise

Exercise OTHER

All groups will participate in a standardized exercise intervention.

Carbohydrate Diet & Carbohydrate Supplement(Carb10) & Exercise; Carbohydrate Diet & Placebo & Exercise; Ketogenic Diet & Carbohydrate Supplement (Carb10) & Exercise; Ketogenic Diet & Placebo & Exercise

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• consistently exercising at least 3 days per week for the past 2 years, participating in both cardiovascular and resistance exercise at least once per week for the past 2 years, reported themselves as healthy, and were willing and able to comply with study protocols

You may not qualify if:

• using tobacco of any form, a history of medical events, reporting any supplement or medication use that may affect study outcomes, regularly consuming \> 7 alcoholic beverages per week, appearing unfit to handle the training program, inability to complete baseline testing, having a BMI \> 35 kg/m2, or becoming \< 80% compliant with training or dietary interventions.

Sponsors & Collaborators

• Texas Woman's University: lead
• Compound Solutions Inc.: collaborator

Study Sites (1)

Texas Woman's University

Denton, Texas, 76204, United States

Location

Related Publications (4)

• Volek JS, Freidenreich DJ, Saenz C, Kunces LJ, Creighton BC, Bartley JM, Davitt PM, Munoz CX, Anderson JM, Maresh CM, Lee EC, Schuenke MD, Aerni G, Kraemer WJ, Phinney SD. Metabolic characteristics of keto-adapted ultra-endurance runners. Metabolism. 2016 Mar;65(3):100-10. doi: 10.1016/j.metabol.2015.10.028. Epub 2015 Nov 2.

  PMID: 26892521 BACKGROUND

• Wilson JM, Lowery RP, Roberts MD, Sharp MH, Joy JM, Shields KA, Partl JM, Volek JS, D'Agostino DP. Effects of Ketogenic Dieting on Body Composition, Strength, Power, and Hormonal Profiles in Resistance Training Men. J Strength Cond Res. 2020 Dec;34(12):3463-3474. doi: 10.1519/JSC.0000000000001935.

  PMID: 28399015 BACKGROUND

• Burke LM, Ross ML, Garvican-Lewis LA, Welvaert M, Heikura IA, Forbes SG, Mirtschin JG, Cato LE, Strobel N, Sharma AP, Hawley JA. Low carbohydrate, high fat diet impairs exercise economy and negates the performance benefit from intensified training in elite race walkers. J Physiol. 2017 May 1;595(9):2785-2807. doi: 10.1113/JP273230. Epub 2017 Feb 14.

  PMID: 28012184 BACKGROUND

• Urbain P, Strom L, Morawski L, Wehrle A, Deibert P, Bertz H. Impact of a 6-week non-energy-restricted ketogenic diet on physical fitness, body composition and biochemical parameters in healthy adults. Nutr Metab (Lond). 2017 Feb 20;14:17. doi: 10.1186/s12986-017-0175-5. eCollection 2017.

  PMID: 28239404 BACKGROUND

MeSH Terms

Interventions

Diet; Exercise

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jordan Joy, MS

  Texas Woman's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to the pre-workout drink content.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Semi-randomized, parallel-group, single-blind diet and exercise intervention

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 27, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 20, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)