Determining the Ergogenic Effects of Carb10™ Supplementation on Carbohydrate-Rich and Carbohydrate-Restricted Diets
NCT ID: NCT03231514
Last Updated: 2018-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
59 participants
INTERVENTIONAL
2017-01-31
2017-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Ketogenic Diet on Glucose Metabolism and Energy Expenditure in Type 2 Diabetes
NCT04791787
Carnitine Supplementation in Type 2 Diabetic Patients
NCT03230812
Effects of a Novel Supplement on Glycemic Variability Measured by Continuous Glucose Monitoring
NCT05832463
Examining the Effect of Exogenous Ketone Supplementation on Glucose Control in Type 2 Diabetes
NCT05155410
The Effect of Ketone Esters on Forearm Glucose Metabolism
NCT06685913
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Carbohydrate Diet & Placebo & Exercise
This group receives the carbohydrate-based diet and flavored placebo pre-workout drink. All participate in the exercise intervention.
Exercise
All groups will participate in a standardized exercise intervention.
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.
Carbohydrate Supplement (Carb10)
2 of 4 arms will be supplemented with carbohydrate pre-workout (Carb10, Compound Solutions, Carlsbad, CA)
Exercise
All groups will participate in a standardized exercise intervention.
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.
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.
Ketogenic Diet & Carbohydrate Supplement (Carb10) & Exercise
This group receives the ketogenic diet and supplemental carbohydrate. All participate in the exercise intervention.
Carbohydrate Supplement (Carb10)
2 of 4 arms will be supplemented with carbohydrate pre-workout (Carb10, Compound Solutions, Carlsbad, CA)
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Carbohydrate Supplement (Carb10)
2 of 4 arms will be supplemented with carbohydrate pre-workout (Carb10, Compound Solutions, Carlsbad, CA)
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
30 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Compound Solutions Inc.
INDUSTRY
Texas Woman's University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jordan Joy
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jordan Joy, MS
Role: PRINCIPAL_INVESTIGATOR
Texas Woman's University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Texas Woman's University
Denton, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
19151
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.