Texas Woman's University
Denton, Texas, 76204, United States
NCT Number: NCT03231514
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."
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Notify Me18 year–30 year
All sexes
Interventional
Not applicable
Denton, Texas, 76204, United States
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 0 and 10 weeks
Will be measured as fat and lean soft tissue mass in kg by dual x-ray absorptiometry (DXA)
Time frame: 0 and 10 weeks
Will be measured as peak and average power output in Watts during a repeated Wingate sprint test
Time frame: 0 and 10 weeks
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
BIS determined total, intra-, and extra-cellular fluid in Liters
Time frame: 0 and 10 weeks
B-mode ultrasound determined cross-sectional area of the rectus femoris in cm squared
Time frame: 0 and 10 weeks
B-mode ultrasound determined combined thickness of the vastus lateralis and vastus medius in cm
Time frame: 0 and 10 weeks
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
measured using vertec
Time frame: 0 and 10 weeks
measured using linear force transducer
Time frame: 0 and 10 weeks
measured using linear force transducer
Time frame: 0 and 10 weeks
measured using linear force transducer
Time frame: 0 and 10 weeks
measured as 1 repetition maximum
Time frame: 0 and 10 weeks
measured using clinical analyzer pmol/L
Time frame: 0 and 10 weeks
measured using clinical analyzer mg/dL
Time frame: 0 and 10 weeks
measured using clinical analyzer mg/dL
Time frame: 0 and 10 weeks
measured using clinical analyzer mg/dL
Time frame: 0 and 10 weeks
measured using clinical analyzer U/L
Time frame: 0 and 10 weeks
measured using clinical analyzer U/L
Time frame: 0 and 10 weeks
measured using clinical analyzer mmol/mol
Time frame: 0 and 10 weeks
measured using clinical analyzer U/L
Time frame: 0 and 10 weeks
measured using ELISA ng/dL
Time frame: 0 and 10 weeks
measured using ELISA ng/dL
Time frame: 0 and 10 weeks
measured using ELISA pg/mL
Time frame: 0 and 10 weeks
measured using ELISA ng/dL
Time frame: 0 and 10 weeks
measured using ELISA ng/dL
Time frame: 0 and 10 weeks
measured using ELISA mu/L
Time frame: 0 and 10 weeks
measured using ELISA mg/L
Time frame: 0 and 10 weeks
measured using ELISA ug/dL
Time frame: 0 and 10 weeks
measured using ELISA nmol/L
Time frame: 0 and 10 weeks
measured using ELISA ug/dL
Time frame: about every 3-7 days
measured using handheld meter mmol/L
Texas Woman's University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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