Ketogenic DietingNCT03231514
Determining the Ergogenic Effects of Carb10™ Supplementation on Carbohydrate-Rich and Carbohydrate-Restricted Diets
A study testing Carbohydrate Supplement (Carb10), Diet and Exercise in people with Ketogenic Dieting, run by Texas Woman's University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Ketogenic Dieting
- What is being tested?
- Carbohydrate Supplement (Carb10), Diet and Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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."
Read the 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).
- Conditions
- Ketogenic Dieting
- Being tested
- Carbohydrate Supplement (Carb10), Diet, Exercise
- Keywords
- body composition, exercise performance, keto-adaptation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate Supplement (Carb10)Dietary supplement
2 of 4 arms will be supplemented with carbohydrate pre-workout (Carb10, Compound Solutions, Carlsbad, CA)
DietOther
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)
ExerciseOther
All groups will participate in a standardized exercise intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Carbohydrate Supplement (Carb10); Other: Diet; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Composition
Will be measured as fat and lean soft tissue mass in kg by dual x-ray absorptiometry (DXA)
Measured: 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
Measured: 0 and 10 weeks
Secondary outcomes (29)
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
Measured: 0 and 10 weeks
Change in Body Water
BIS determined total, intra-, and extra-cellular fluid in Liters
Measured: 0 and 10 weeks
Change in Cross-sectional Area
B-mode ultrasound determined cross-sectional area of the rectus femoris in cm squared
Measured: 0 and 10 weeks
Change in Muscle Thickness
B-mode ultrasound determined combined thickness of the vastus lateralis and vastus medius in cm
Measured: 0 and 10 weeks
Change in Aerobic Performance
measured as a 5km time trial with a 250m hill segment (8% grade) at 1km and 4km on a treadmill
Measured: 0 and 10 weeks
Change in Vertical Jump Height
measured using vertec
Measured: 0 and 10 weeks
Change in Vertical Jump Power
measured using linear force transducer
Measured: 0 and 10 weeks
Change in Vertical Jump Velocity
measured using linear force transducer
Measured: 0 and 10 weeks
Change in Vertical Jump Force
measured using linear force transducer
Measured: 0 and 10 weeks
Change in Strength
measured as 1 repetition maximum
Measured: 0 and 10 weeks
Change in Insulin
measured using clinical analyzer pmol/L
Measured: 0 and 10 weeks
Change in HDL
measured using clinical analyzer mg/dL
Measured: 0 and 10 weeks
Changes in LDL
measured using clinical analyzer mg/dL
Measured: 0 and 10 weeks
Changes in Triglycerides
measured using clinical analyzer mg/dL
Measured: 0 and 10 weeks
Changes in Aspartate Amino Transferase
measured using clinical analyzer U/L
Measured: 0 and 10 weeks
Changes in Alanine amino Transferase
measured using clinical analyzer U/L
Measured: 0 and 10 weeks
Changes in HbA1C
measured using clinical analyzer mmol/mol
Measured: 0 and 10 weeks
Changes in Creatine Kinase
measured using clinical analyzer U/L
Measured: 0 and 10 weeks
Changes in Total Testosterone
measured using ELISA ng/dL
Measured: 0 and 10 weeks
Changes in Free Testosterone
measured using ELISA ng/dL
Measured: 0 and 10 weeks
Changes in Total Estrogens
measured using ELISA pg/mL
Measured: 0 and 10 weeks
Changes in Triiodothyronine
measured using ELISA ng/dL
Measured: 0 and 10 weeks
Changes in Thyroxine
measured using ELISA ng/dL
Measured: 0 and 10 weeks
Changes in Thyroid Stimulating Hormone
measured using ELISA mu/L
Measured: 0 and 10 weeks
changes in C-reactive Protein
measured using ELISA mg/L
Measured: 0 and 10 weeks
Changes in Dehydroepiandrosterone sulfate
measured using ELISA ug/dL
Measured: 0 and 10 weeks
Changes in Sex hormone Binding Globulin
measured using ELISA nmol/L
Measured: 0 and 10 weeks
Changes in Cortisol
measured using ELISA ug/dL
Measured: 0 and 10 weeks
Changes in Whole Blood Betahydroxybutyrate
measured using handheld meter mmol/L
Measured: about every 3-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study startJan 2017
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ketogenic DietingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Semi-randomized, parallel-group, single-blind diet and exercise intervention
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Collaborators
- Compound Solutions Inc.
- Responsible party
- Principal investigator, Jordan Joy, Texas Woman's University
- Investigators
- Jordan Joy, MS, Principal investigator, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231514
- Sponsor's protocol ID
- 19151
- Status last verified
- Feb 2018
- First submitted
- 12 Jul 2017
- Last updated
- 20 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26892521Wilson 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.
PubMed 28399015Burke 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.
PubMed 28012184Urbain 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.
PubMed 28239404
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Ergogenic Effects of Carb10™ Supplementation on Carbohydrate-Rich and Carbohydrate-Restricted Diets
- ClinicalTrials.gov ID
- NCT03231514
- Acronym / sponsor ID
- 19151
- Conditions
- Ketogenic Dieting
- Keywords
- body composition, exercise performance, keto-adaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Collaborators
- Compound Solutions Inc.
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 27 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Semi-randomized, parallel-group, single-blind diet and exercise intervention
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate Diet & Placebo & Exercise | Placebo comparator | Other: ExerciseThis group receives the carbohydrate-based diet and flavored placebo pre-workout drink. All participate in the exercise intervention. |
| Carbohydrate Diet & Carbohydrate Supplement(Carb10) & Exercise | Active comparator | Dietary Supplement: Carbohydrate Supplement (Carb10), Other: ExerciseThis 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. |
| Ketogenic Diet & Placebo & Exercise | Experimental | Other: Diet, Other: ExerciseThis 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. |
| Ketogenic Diet & Carbohydrate Supplement (Carb10) & Exercise | Experimental | Dietary Supplement: Carbohydrate Supplement (Carb10), Other: Diet, Other: ExerciseThis group receives the ketogenic diet and supplemental carbohydrate. All participate in the exercise intervention. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbohydrate Supplement (Carb10)2 of 4 arms will be supplemented with carbohydrate pre-workout (Carb10, Compound Solutions, Carlsbad, CA) | Dietary supplement | Carbohydrate Diet & Carbohydrate Supplement(Carb10) & Exercise, Ketogenic Diet & Carbohydrate Supplement (Carb10) & Exercise |
| Diet2 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 | Ketogenic Diet & Carbohydrate Supplement (Carb10) & Exercise, Ketogenic Diet & Placebo & Exercise |
| ExerciseAll groups will participate in a standardized exercise intervention. | Other | Carbohydrate Diet & Carbohydrate Supplement(Carb10) & Exercise, Carbohydrate Diet & Placebo & Exercise, Ketogenic Diet & Carbohydrate Supplement (Carb10) & Exercise, Ketogenic Diet & Placebo & Exercise |
Primary outcome
Change in Body Composition
Time frame: 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
Time frame: 0 and 10 weeks
Will be measured as peak and average power output in Watts during a repeated Wingate sprint test
29 secondary outcomes
Change in Body Composition
Time frame: 0 and 10 weeks
Change in Body Water
Time frame: 0 and 10 weeks
Change in Cross-sectional Area
Time frame: 0 and 10 weeks
Change in Muscle Thickness
Time frame: 0 and 10 weeks
Change in Aerobic Performance
Time frame: 0 and 10 weeks
Change in Vertical Jump Height
Time frame: 0 and 10 weeks
Change in Vertical Jump Power
Time frame: 0 and 10 weeks
Change in Vertical Jump Velocity
Time frame: 0 and 10 weeks
Change in Vertical Jump Force
Time frame: 0 and 10 weeks
Change in Strength
Time frame: 0 and 10 weeks
Change in Insulin
Time frame: 0 and 10 weeks
Change in HDL
Time frame: 0 and 10 weeks
Changes in LDL
Time frame: 0 and 10 weeks
Changes in Triglycerides
Time frame: 0 and 10 weeks
Changes in Aspartate Amino Transferase
Time frame: 0 and 10 weeks
Changes in Alanine amino Transferase
Time frame: 0 and 10 weeks
Changes in HbA1C
Time frame: 0 and 10 weeks
Changes in Creatine Kinase
Time frame: 0 and 10 weeks
Changes in Total Testosterone
Time frame: 0 and 10 weeks
Changes in Free Testosterone
Time frame: 0 and 10 weeks
Changes in Total Estrogens
Time frame: 0 and 10 weeks
Changes in Triiodothyronine
Time frame: 0 and 10 weeks
Changes in Thyroxine
Time frame: 0 and 10 weeks
Changes in Thyroid Stimulating Hormone
Time frame: 0 and 10 weeks
changes in C-reactive Protein
Time frame: 0 and 10 weeks
Changes in Dehydroepiandrosterone sulfate
Time frame: 0 and 10 weeks
Changes in Sex hormone Binding Globulin
Time frame: 0 and 10 weeks
Changes in Cortisol
Time frame: 0 and 10 weeks
Changes in Whole Blood Betahydroxybutyrate
Time frame: about every 3-7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2018.
- Background: PubMed 26892521Volek 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.
- Background: PubMed 28399015Wilson 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.
- Background: PubMed 28012184Burke 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.
- Background: PubMed 28239404Urbain 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.
- Individual participant dataSharing planned: No
Related trials for Ketogenic Dieting
Recruiting
Ketogenic Diet and Diabetes Demonstration Project
Type 2 Diabetes, PreDiabetes
RecruitingPhase 3
Ketogenic Diet for New-Onset Absence Epilepsy
Absence Epilepsy, Ketogenic Dieting
Active, not recruitingPhase 2/3
Effect of Nutritional Ketosis on Alcohol Metabolism
Ketoses, Metabolic, Ketogenic Dieting
Recruiting
Nutritional Ketosis: a Novel Metabolic Strategy to Treat Lymphedema Patients?
Lymphedema, Ketogenic Dieting
Not yet recruiting
Ketogenic Metabolic Therapy in Schizophrenia, Bipolar Disorder, Major Depressive Disorder: Deep Omic Profiling
Schizophrenia, Schizophrenia and Related Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordan Joy, MS principal investigator
Texas Woman's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate Supplement (Carb10), Diet and Exercise in people with Ketogenic Dieting, run by Texas Woman's University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Composition (time frame: 0 and 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03231514, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2018.