Clinical trial NCT03231514: Determining the Ergogenic Effects of Carb10™ Supplementation on Carbohydrate-Rich and Carbohydrate-Restricted Diets
Official title: Determining the Ergogenic Effects of Carb10™ Supplementation on Carbohydrate-Rich and Carbohydrate-Restricted Diets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ketogenic Dieting
Keywords: body composition
exercise performance
keto-adaptation
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
Collaborators: name: Compound Solutions Inc.
First posted: 2017-07-27
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Semi-randomized, parallel-group, single-blind diet and exercise intervention
Primary purpose: OTHER

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."

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).

Eligibility 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.

Primary outcomes:
measure: Change in Body Composition
timeFrame: 0 and 10 weeks
measure: Change in Anaerobic Cardiovascular Performance
timeFrame: 0 and 10 weeks
Secondary outcomes:
measure: Change in Body Composition
timeFrame: 0 and 10 weeks
measure: Change in Body Water
timeFrame: 0 and 10 weeks
measure: Change in Cross-sectional Area
timeFrame: 0 and 10 weeks
measure: Change in Muscle Thickness
timeFrame: 0 and 10 weeks
measure: Change in Aerobic Performance
timeFrame: 0 and 10 weeks
measure: Change in Vertical Jump Height
timeFrame: 0 and 10 weeks
measure: Change in Vertical Jump Power
timeFrame: 0 and 10 weeks
measure: Change in Vertical Jump Velocity
timeFrame: 0 and 10 weeks
measure: Change in Vertical Jump Force
timeFrame: 0 and 10 weeks
measure: Change in Strength
timeFrame: 0 and 10 weeks
measure: Change in Insulin
timeFrame: 0 and 10 weeks
measure: Change in HDL
timeFrame: 0 and 10 weeks
measure: Changes in LDL
timeFrame: 0 and 10 weeks
measure: Changes in Triglycerides
timeFrame: 0 and 10 weeks
measure: Changes in Aspartate Amino Transferase
timeFrame: 0 and 10 weeks
measure: Changes in Alanine amino Transferase
timeFrame: 0 and 10 weeks
measure: Changes in HbA1C
timeFrame: 0 and 10 weeks
measure: Changes in Creatine Kinase
timeFrame: 0 and 10 weeks
measure: Changes in Total Testosterone
timeFrame: 0 and 10 weeks
measure: Changes in Free Testosterone
timeFrame: 0 and 10 weeks
measure: Changes in Total Estrogens
timeFrame: 0 and 10 weeks
measure: Changes in Triiodothyronine
timeFrame: 0 and 10 weeks
measure: Changes in Thyroxine
timeFrame: 0 and 10 weeks
measure: Changes in Thyroid Stimulating Hormone
timeFrame: 0 and 10 weeks
measure: changes in C-reactive Protein
timeFrame: 0 and 10 weeks
measure: Changes in Dehydroepiandrosterone sulfate
timeFrame: 0 and 10 weeks
measure: Changes in Sex hormone Binding Globulin
timeFrame: 0 and 10 weeks
measure: Changes in Cortisol
timeFrame: 0 and 10 weeks
measure: Changes in Whole Blood Betahydroxybutyrate
timeFrame: about every 3-7 days
Other outcomes:
Locations:
city: Denton
country: United States
facility: Texas Woman's University
state: Texas
Study officials:
affiliation: Texas Woman's University
name: Jordan Joy, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.
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.