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Completed

NCT Number: NCT03231514

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

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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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Woman's University

Denton, Texas, 76204, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Carbohydrate Supplement (Carb10)

Dietary Supplement

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

Diet

Other

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

Other

All groups will participate in a standardized exercise intervention.

Primary outcomes

  1. 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)

  2. 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

Secondary outcomes

  1. Change in Body Composition

    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

  2. Change in Body Water

    Time frame: 0 and 10 weeks

    BIS determined total, intra-, and extra-cellular fluid in Liters

  3. Change in Cross-sectional Area

    Time frame: 0 and 10 weeks

    B-mode ultrasound determined cross-sectional area of the rectus femoris in cm squared

  4. Change in Muscle Thickness

    Time frame: 0 and 10 weeks

    B-mode ultrasound determined combined thickness of the vastus lateralis and vastus medius in cm

  5. Change in Aerobic Performance

    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

  6. Change in Vertical Jump Height

    Time frame: 0 and 10 weeks

    measured using vertec

  7. Change in Vertical Jump Power

    Time frame: 0 and 10 weeks

    measured using linear force transducer

  8. Change in Vertical Jump Velocity

    Time frame: 0 and 10 weeks

    measured using linear force transducer

  9. Change in Vertical Jump Force

    Time frame: 0 and 10 weeks

    measured using linear force transducer

  10. Change in Strength

    Time frame: 0 and 10 weeks

    measured as 1 repetition maximum

  11. Change in Insulin

    Time frame: 0 and 10 weeks

    measured using clinical analyzer pmol/L

  12. Change in HDL

    Time frame: 0 and 10 weeks

    measured using clinical analyzer mg/dL

  13. Changes in LDL

    Time frame: 0 and 10 weeks

    measured using clinical analyzer mg/dL

  14. Changes in Triglycerides

    Time frame: 0 and 10 weeks

    measured using clinical analyzer mg/dL

  15. Changes in Aspartate Amino Transferase

    Time frame: 0 and 10 weeks

    measured using clinical analyzer U/L

  16. Changes in Alanine amino Transferase

    Time frame: 0 and 10 weeks

    measured using clinical analyzer U/L

  17. Changes in HbA1C

    Time frame: 0 and 10 weeks

    measured using clinical analyzer mmol/mol

  18. Changes in Creatine Kinase

    Time frame: 0 and 10 weeks

    measured using clinical analyzer U/L

  19. Changes in Total Testosterone

    Time frame: 0 and 10 weeks

    measured using ELISA ng/dL

  20. Changes in Free Testosterone

    Time frame: 0 and 10 weeks

    measured using ELISA ng/dL

  21. Changes in Total Estrogens

    Time frame: 0 and 10 weeks

    measured using ELISA pg/mL

  22. Changes in Triiodothyronine

    Time frame: 0 and 10 weeks

    measured using ELISA ng/dL

  23. Changes in Thyroxine

    Time frame: 0 and 10 weeks

    measured using ELISA ng/dL

  24. Changes in Thyroid Stimulating Hormone

    Time frame: 0 and 10 weeks

    measured using ELISA mu/L

  25. changes in C-reactive Protein

    Time frame: 0 and 10 weeks

    measured using ELISA mg/L

  26. Changes in Dehydroepiandrosterone sulfate

    Time frame: 0 and 10 weeks

    measured using ELISA ug/dL

  27. Changes in Sex hormone Binding Globulin

    Time frame: 0 and 10 weeks

    measured using ELISA nmol/L

  28. Changes in Cortisol

    Time frame: 0 and 10 weeks

    measured using ELISA ug/dL

  29. Changes in Whole Blood Betahydroxybutyrate

    Time frame: about every 3-7 days

    measured using handheld meter mmol/L

Sponsors and collaborators

Lead sponsor

Texas Woman's University

Other

Collaborators

  • Compound Solutions Inc.

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 27, 2017
Registry last updated
Feb 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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