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

Ketogenic Dieting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03231514
• Other study ID #: 19151
• Status: Completed
• Phase: N/A
• First received: July 12, 2017
• Last updated: February 16, 2018
• Start date: January 2017
• Est. completion date: December 2017

Study information

• Verified date: February 2018
• Source: Texas Woman's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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."

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ketogenic Dieting

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)
• Exercise
All groups will participate in a standardized exercise intervention.

Locations

Country	Name	City	State
United States	Texas Woman's University	Denton	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas Woman's University	Compound Solutions Inc.

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Wilson JM, Lowery RP, Roberts MD, Sharp MH, Joy JM, Shields KA, Partl J, Volek JS, D'Agostino D. The Effects of Ketogenic Dieting on Body Composition, Strength, Power, and Hormonal Profiles in Resistance Training Males. J Strength Cond Res. 2017 Apr 7. doi: 10.1519/JSC.0000000000001935. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in Body Composition	In addition to DXA, body composition will be verified using bioelectric impedance (BIS) estimations of fat-free and fat mass in kg	0 and 10 weeks
Secondary	Change in Body Water	BIS determined total, intra-, and extra-cellular fluid in Liters	0 and 10 weeks
Secondary	Change in Cross-sectional Area	B-mode ultrasound determined cross-sectional area of the rectus femoris in cm squared	0 and 10 weeks
Secondary	Change in Muscle Thickness	B-mode ultrasound determined combined thickness of the vastus lateralis and vastus medius in cm	0 and 10 weeks
Secondary	Change in Aerobic Performance	measured as a 5km time trial with a 250m hill segment (8% grade) at 1km and 4km on a treadmill	0 and 10 weeks
Secondary	Change in Vertical Jump Height	measured using vertec	0 and 10 weeks
Secondary	Change in Vertical Jump Power	measured using linear force transducer	0 and 10 weeks
Secondary	Change in Vertical Jump Velocity	measured using linear force transducer	0 and 10 weeks
Secondary	Change in Vertical Jump Force	measured using linear force transducer	0 and 10 weeks
Secondary	Change in Strength	measured as 1 repetition maximum	0 and 10 weeks
Secondary	Change in Insulin	measured using clinical analyzer pmol/L	0 and 10 weeks
Secondary	Change in HDL	measured using clinical analyzer mg/dL	0 and 10 weeks
Secondary	Changes in LDL	measured using clinical analyzer mg/dL	0 and 10 weeks
Secondary	Changes in Triglycerides	measured using clinical analyzer mg/dL	0 and 10 weeks
Secondary	Changes in Aspartate Amino Transferase	measured using clinical analyzer U/L	0 and 10 weeks
Secondary	Changes in Alanine amino Transferase	measured using clinical analyzer U/L	0 and 10 weeks
Secondary	Changes in HbA1C	measured using clinical analyzer mmol/mol	0 and 10 weeks
Secondary	Changes in Creatine Kinase	measured using clinical analyzer U/L	0 and 10 weeks
Secondary	Changes in Total Testosterone	measured using ELISA ng/dL	0 and 10 weeks
Secondary	Changes in Free Testosterone	measured using ELISA ng/dL	0 and 10 weeks
Secondary	Changes in Total Estrogens	measured using ELISA pg/mL	0 and 10 weeks
Secondary	Changes in Triiodothyronine	measured using ELISA ng/dL	0 and 10 weeks
Secondary	Changes in Thyroxine	measured using ELISA ng/dL	0 and 10 weeks
Secondary	Changes in Thyroid Stimulating Hormone	measured using ELISA mu/L	0 and 10 weeks
Secondary	changes in C-reactive Protein	measured using ELISA mg/L	0 and 10 weeks
Secondary	Changes in Dehydroepiandrosterone sulfate	measured using ELISA ug/dL	0 and 10 weeks
Secondary	Changes in Sex hormone Binding Globulin	measured using ELISA nmol/L	0 and 10 weeks
Secondary	Changes in Cortisol	measured using ELISA ug/dL	0 and 10 weeks
Secondary	Changes in Whole Blood Betahydroxybutyrate	measured using handheld meter mmol/L	about every 3-7 days