Determining the Ergogenic Effects of Carb10™ Supplementation on Carbohydrate-Rich and Carbohydrate-Restricted Diets
Study Details
Study Description
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."
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Participants will be recruited from TWU and the Denton area and grouped in a semi-randomized fashion that considers dietary preferences. They will then undergo baseline testing, begin the diet and training interventions, followed by post-testing (phase 1) and a carbohydrate titration period in the ketogenic diet group (phase 2). In the following academic semester, the training intervention will be repeated with an adjusted dietary carbohydrate level, delivered as a pre-workout supplement, corresponding to Phase 2 (Phase 3).
Phase 1 will consist of diets at an energy level estimated by the Mifflin St. Jeor equation adjusted by 1.625 for exercise. The exercise intervention will be a supervised, periodized (daily undulating), 9-week concurrent resistance (3 days/week) and cardiovascular (2 days/week) exercise program designed to improve body composition and performance variables. During phase 2, the ketogenic diet participants will continue exercising with the same program while consuming incrementally greater quantities of carbohydrate pre-workout until the state of ketosis is lost. Phase 3 will be identical to Phase 1, but diets will be modified to include more carbohydrate. As of completing Phase 2, this amount has been determined to be 20g of Carb10 (pea starch).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Carbohydrate Diet & Placebo & Exercise This group receives the carbohydrate-based diet and flavored placebo pre-workout drink. All participate in the exercise intervention. |
Other: Exercise
All groups will participate in a standardized exercise intervention.
|
| Active Comparator: Carbohydrate Diet & Carbohydrate Supplement(Carb10) & Exercise 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)
2 of 4 arms will be supplemented with carbohydrate pre-workout (Carb10, Compound Solutions, Carlsbad, CA)
Other: Exercise
All groups will participate in a standardized exercise intervention.
|
| Experimental: Ketogenic Diet & Placebo & Exercise 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
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)
Other: Exercise
All groups will participate in a standardized exercise intervention.
|
| Experimental: Ketogenic Diet & Carbohydrate Supplement (Carb10) & Exercise This group receives the ketogenic diet and supplemental carbohydrate. All participate in the exercise intervention. |
Dietary Supplement: Carbohydrate Supplement (Carb10)
2 of 4 arms will be supplemented with carbohydrate pre-workout (Carb10, Compound Solutions, Carlsbad, CA)
Other: Diet
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)
Other: Exercise
All groups will participate in a standardized exercise intervention.
|
Outcome Measures
Primary Outcome Measures
- Change in Body Composition [0 and 10 weeks]
Will be measured as fat and lean soft tissue mass in kg by dual x-ray absorptiometry (DXA)
- Change in Anaerobic Cardiovascular Performance [0 and 10 weeks]
Will be measured as peak and average power output in Watts during a repeated Wingate sprint test
Secondary Outcome Measures
- Change in Body Composition [0 and 10 weeks]
In addition to DXA, body composition will be verified using bioelectric impedance (BIS) estimations of fat-free and fat mass in kg
- Change in Body Water [0 and 10 weeks]
BIS determined total, intra-, and extra-cellular fluid in Liters
- Change in Cross-sectional Area [0 and 10 weeks]
B-mode ultrasound determined cross-sectional area of the rectus femoris in cm squared
- Change in Muscle Thickness [0 and 10 weeks]
B-mode ultrasound determined combined thickness of the vastus lateralis and vastus medius in cm
- Change in Aerobic Performance [0 and 10 weeks]
measured as a 5km time trial with a 250m hill segment (8% grade) at 1km and 4km on a treadmill
- Change in Vertical Jump Height [0 and 10 weeks]
measured using vertec
- Change in Vertical Jump Power [0 and 10 weeks]
measured using linear force transducer
- Change in Vertical Jump Velocity [0 and 10 weeks]
measured using linear force transducer
- Change in Vertical Jump Force [0 and 10 weeks]
measured using linear force transducer
- Change in Strength [0 and 10 weeks]
measured as 1 repetition maximum
- Change in Insulin [0 and 10 weeks]
measured using clinical analyzer pmol/L
- Change in HDL [0 and 10 weeks]
measured using clinical analyzer mg/dL
- Changes in LDL [0 and 10 weeks]
measured using clinical analyzer mg/dL
- Changes in Triglycerides [0 and 10 weeks]
measured using clinical analyzer mg/dL
- Changes in Aspartate Amino Transferase [0 and 10 weeks]
measured using clinical analyzer U/L
- Changes in Alanine amino Transferase [0 and 10 weeks]
measured using clinical analyzer U/L
- Changes in HbA1C [0 and 10 weeks]
measured using clinical analyzer mmol/mol
- Changes in Creatine Kinase [0 and 10 weeks]
measured using clinical analyzer U/L
- Changes in Total Testosterone [0 and 10 weeks]
measured using ELISA ng/dL
- Changes in Free Testosterone [0 and 10 weeks]
measured using ELISA ng/dL
- Changes in Total Estrogens [0 and 10 weeks]
measured using ELISA pg/mL
- Changes in Triiodothyronine [0 and 10 weeks]
measured using ELISA ng/dL
- Changes in Thyroxine [0 and 10 weeks]
measured using ELISA ng/dL
- Changes in Thyroid Stimulating Hormone [0 and 10 weeks]
measured using ELISA mu/L
- changes in C-reactive Protein [0 and 10 weeks]
measured using ELISA mg/L
- Changes in Dehydroepiandrosterone sulfate [0 and 10 weeks]
measured using ELISA ug/dL
- Changes in Sex hormone Binding Globulin [0 and 10 weeks]
measured using ELISA nmol/L
- Changes in Cortisol [0 and 10 weeks]
measured using ELISA ug/dL
- Changes in Whole Blood Betahydroxybutyrate [about every 3-7 days]
measured using handheld meter mmol/L
Eligibility Criteria
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Texas Woman's University | Denton | Texas | United States | 76204 |
Sponsors and Collaborators
- Texas Woman's University
- Compound Solutions Inc.
Investigators
- Principal Investigator: Jordan Joy, MS, Texas Woman's University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
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