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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03231514
Enrollment
59
Registered
2017-07-27
Start date
2017-01-31
Completion date
2017-12-31
Last updated
2018-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ketogenic Dieting

Keywords

body composition, exercise performance, keto-adaptation

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).

Interventions

DIETARY_SUPPLEMENTCarbohydrate Supplement (Carb10)

2 of 4 arms will be supplemented with carbohydrate pre-workout (Carb10, Compound Solutions, Carlsbad, CA)

OTHERDiet

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)

OTHERExercise

All groups will participate in a standardized exercise intervention.

Sponsors

Compound Solutions Inc.
CollaboratorINDUSTRY
Texas Woman's University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

Participants are blinded to the pre-workout drink content.

Intervention model description

Semi-randomized, parallel-group, single-blind diet and exercise intervention

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Body Composition0 and 10 weeksWill be measured as fat and lean soft tissue mass in kg by dual x-ray absorptiometry (DXA)
Change in Anaerobic Cardiovascular Performance0 and 10 weeksWill be measured as peak and average power output in Watts during a repeated Wingate sprint test

Secondary

MeasureTime frameDescription
Changes in Sex hormone Binding Globulin0 and 10 weeksmeasured using ELISA nmol/L
Changes in Cortisol0 and 10 weeksmeasured using ELISA ug/dL
Changes in Whole Blood Betahydroxybutyrateabout every 3-7 daysmeasured using handheld meter mmol/L
Change in Body Composition0 and 10 weeksIn addition to DXA, body composition will be verified using bioelectric impedance (BIS) estimations of fat-free and fat mass in kg
Change in Body Water0 and 10 weeksBIS determined total, intra-, and extra-cellular fluid in Liters
Change in Cross-sectional Area0 and 10 weeksB-mode ultrasound determined cross-sectional area of the rectus femoris in cm squared
Changes in Thyroid Stimulating Hormone0 and 10 weeksmeasured using ELISA mu/L
Change in Muscle Thickness0 and 10 weeksB-mode ultrasound determined combined thickness of the vastus lateralis and vastus medius in cm
Change in Aerobic Performance0 and 10 weeksmeasured as a 5km time trial with a 250m hill segment (8% grade) at 1km and 4km on a treadmill
Change in Vertical Jump Height0 and 10 weeksmeasured using vertec
Change in Vertical Jump Power0 and 10 weeksmeasured using linear force transducer
Change in Vertical Jump Velocity0 and 10 weeksmeasured using linear force transducer
Change in Vertical Jump Force0 and 10 weeksmeasured using linear force transducer
changes in C-reactive Protein0 and 10 weeksmeasured using ELISA mg/L
Change in Insulin0 and 10 weeksmeasured using clinical analyzer pmol/L
Change in HDL0 and 10 weeksmeasured using clinical analyzer mg/dL
Changes in LDL0 and 10 weeksmeasured using clinical analyzer mg/dL
Changes in Triglycerides0 and 10 weeksmeasured using clinical analyzer mg/dL
Changes in Aspartate Amino Transferase0 and 10 weeksmeasured using clinical analyzer U/L
Changes in Alanine amino Transferase0 and 10 weeksmeasured using clinical analyzer U/L
Changes in HbA1C0 and 10 weeksmeasured using clinical analyzer mmol/mol
Changes in Creatine Kinase0 and 10 weeksmeasured using clinical analyzer U/L
Changes in Total Testosterone0 and 10 weeksmeasured using ELISA ng/dL
Changes in Free Testosterone0 and 10 weeksmeasured using ELISA ng/dL
Changes in Total Estrogens0 and 10 weeksmeasured using ELISA pg/mL
Changes in Triiodothyronine0 and 10 weeksmeasured using ELISA ng/dL
Changes in Thyroxine0 and 10 weeksmeasured using ELISA ng/dL
Change in Strength0 and 10 weeksmeasured as 1 repetition maximum
Changes in Dehydroepiandrosterone sulfate0 and 10 weeksmeasured using ELISA ug/dL

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026