An interventional study of Carbohydrate Supplement (Carb10) and Diet in Ketogenic Dieting, sponsored by Texas Woman's University. Completed at 1 site in United States. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-20.
Sponsored by Texas Woman's University · Not applicable, Interventional, and Other
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."
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).
Texas Woman's University is the lead sponsor of 82 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group receives the carbohydrate-based diet and flavored placebo pre-workout drink. All participate in the exercise intervention.
Other: 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.
Dietary Supplement: Carbohydrate Supplement (Carb10) · Other: 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.
Other: Diet · Other: Exercise
This group receives the ketogenic diet and supplemental carbohydrate. All participate in the exercise intervention.
Dietary Supplement: Carbohydrate Supplement (Carb10) · Other: Diet · Other: Exercise
2 of 4 arms will be supplemented with carbohydrate pre-workout (Carb10, Compound Solutions, Carlsbad, CA)
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)
All groups will participate in a standardized exercise intervention.
Change in Body Composition
Will be measured as fat and lean soft tissue mass in kg by dual x-ray absorptiometry (DXA)
Time frame: 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
Time frame: 0 and 10 weeks
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
Time frame: 0 and 10 weeks
Change in Body Water
BIS determined total, intra-, and extra-cellular fluid in Liters
Time frame: 0 and 10 weeks
Change in Cross-sectional Area
B-mode ultrasound determined cross-sectional area of the rectus femoris in cm squared
Time frame: 0 and 10 weeks
Change in Muscle Thickness
B-mode ultrasound determined combined thickness of the vastus lateralis and vastus medius in cm
Time frame: 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
Time frame: 0 and 10 weeks
Change in Vertical Jump Height
measured using vertec
Time frame: 0 and 10 weeks
Change in Vertical Jump Power
measured using linear force transducer
Time frame: 0 and 10 weeks
Change in Vertical Jump Velocity
measured using linear force transducer
Time frame: 0 and 10 weeks
Change in Vertical Jump Force
measured using linear force transducer
Time frame: 0 and 10 weeks
Change in Strength
measured as 1 repetition maximum
Time frame: 0 and 10 weeks
Change in Insulin
measured using clinical analyzer pmol/L
Time frame: 0 and 10 weeks
Change in HDL
measured using clinical analyzer mg/dL
Time frame: 0 and 10 weeks
Changes in LDL
measured using clinical analyzer mg/dL
Time frame: 0 and 10 weeks
Changes in Triglycerides
measured using clinical analyzer mg/dL
Time frame: 0 and 10 weeks
Changes in Aspartate Amino Transferase
measured using clinical analyzer U/L
Time frame: 0 and 10 weeks
Changes in Alanine amino Transferase
measured using clinical analyzer U/L
Time frame: 0 and 10 weeks
Changes in HbA1C
measured using clinical analyzer mmol/mol
Time frame: 0 and 10 weeks
Changes in Creatine Kinase
measured using clinical analyzer U/L
Time frame: 0 and 10 weeks
Changes in Total Testosterone
measured using ELISA ng/dL
Time frame: 0 and 10 weeks
Changes in Free Testosterone
measured using ELISA ng/dL
Time frame: 0 and 10 weeks
Changes in Total Estrogens
measured using ELISA pg/mL
Time frame: 0 and 10 weeks
Changes in Triiodothyronine
measured using ELISA ng/dL
Time frame: 0 and 10 weeks
Changes in Thyroxine
measured using ELISA ng/dL
Time frame: 0 and 10 weeks
Changes in Thyroid Stimulating Hormone
measured using ELISA mu/L
Time frame: 0 and 10 weeks
changes in C-reactive Protein
measured using ELISA mg/L
Time frame: 0 and 10 weeks
Changes in Dehydroepiandrosterone sulfate
measured using ELISA ug/dL
Time frame: 0 and 10 weeks
Changes in Sex hormone Binding Globulin
measured using ELISA nmol/L
Time frame: 0 and 10 weeks
Changes in Cortisol
measured using ELISA ug/dL
Time frame: 0 and 10 weeks
Changes in Whole Blood Betahydroxybutyrate
measured using handheld meter mmol/L
Time frame: about every 3-7 days
Plan to share: No
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