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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Ketogenic Dieting

Intervention / Treatment
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* Dietary Supplement: Carbohydrate Supplement (Carb10)
* Other: Diet
* Other: Exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Semi-randomized, parallel-group, single-blind diet and exercise intervention
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Carbohydrate Diet & Placebo & Exercise<br>This group receives the carbohydrate-based diet and flavored placebo pre-workout drink. All participate in the exercise intervention. | Other: Exercise<br>* All groups will participate in a standardized exercise intervention.<br>|
| Active Comparator: Carbohydrate Diet & Carbohydrate Supplement(Carb10) & Exercise<br>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)<br>* 2 of 4 arms will be supplemented with carbohydrate pre-workout (Carb10, Compound Solutions, Carlsbad, CA)<br>Other: Exercise<br>* All groups will participate in a standardized exercise intervention.<br>|
| Experimental: Ketogenic Diet & Placebo & Exercise<br>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<br>* 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)<br>Other: Exercise<br>* All groups will participate in a standardized exercise intervention.<br>|
| Experimental: Ketogenic Diet & Carbohydrate Supplement (Carb10) & Exercise<br>This group receives the ketogenic diet and supplemental carbohydrate. All participate in the exercise intervention. | Dietary Supplement: Carbohydrate Supplement (Carb10)<br>* 2 of 4 arms will be supplemented with carbohydrate pre-workout (Carb10, Compound Solutions, Carlsbad, CA)<br>Other: Diet<br>* 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)<br>Other: Exercise<br>* All groups will participate in a standardized exercise intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Composition | Will be measured as fat and lean soft tissue mass in kg by dual x-ray absorptiometry (DXA) | 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 | 0 and 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 0 and 10 weeks | 
| Change in Body Water | BIS determined total, intra-, and extra-cellular fluid in Liters | 0 and 10 weeks | 
| Change in Cross-sectional Area | B-mode ultrasound determined cross-sectional area of the rectus femoris in cm squared | 0 and 10 weeks | 
| Change in Muscle Thickness | B-mode ultrasound determined combined thickness of the vastus lateralis and vastus medius in cm | 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 | 0 and 10 weeks | 
| Change in Vertical Jump Height | measured using vertec | 0 and 10 weeks | 
| Change in Vertical Jump Power | measured using linear force transducer | 0 and 10 weeks | 
| Change in Vertical Jump Velocity | measured using linear force transducer | 0 and 10 weeks | 
| Change in Vertical Jump Force | measured using linear force transducer | 0 and 10 weeks | 
| Change in Strength | measured as 1 repetition maximum | 0 and 10 weeks | 
| Change in Insulin | measured using clinical analyzer pmol/L | 0 and 10 weeks | 
| Change in HDL | measured using clinical analyzer mg/dL | 0 and 10 weeks | 
| Changes in LDL | measured using clinical analyzer mg/dL | 0 and 10 weeks | 
| Changes in Triglycerides | measured using clinical analyzer mg/dL | 0 and 10 weeks | 
| Changes in Aspartate Amino Transferase | measured using clinical analyzer U/L | 0 and 10 weeks | 
| Changes in Alanine amino Transferase | measured using clinical analyzer U/L | 0 and 10 weeks | 
| Changes in HbA1C | measured using clinical analyzer mmol/mol | 0 and 10 weeks | 
| Changes in Creatine Kinase | measured using clinical analyzer U/L | 0 and 10 weeks | 
| Changes in Total Testosterone | measured using ELISA ng/dL | 0 and 10 weeks | 
| Changes in Free Testosterone | measured using ELISA ng/dL | 0 and 10 weeks | 
| Changes in Total Estrogens | measured using ELISA pg/mL | 0 and 10 weeks | 
| Changes in Triiodothyronine | measured using ELISA ng/dL | 0 and 10 weeks | 
| Changes in Thyroxine | measured using ELISA ng/dL | 0 and 10 weeks | 
| Changes in Thyroid Stimulating Hormone | measured using ELISA mu/L | 0 and 10 weeks | 
| changes in C-reactive Protein | measured using ELISA mg/L | 0 and 10 weeks | 
| Changes in Dehydroepiandrosterone sulfate | measured using ELISA ug/dL | 0 and 10 weeks | 
| Changes in Sex hormone Binding Globulin | measured using ELISA nmol/L | 0 and 10 weeks | 
| Changes in Cortisol | measured using ELISA ug/dL | 0 and 10 weeks | 
| Changes in Whole Blood Betahydroxybutyrate | measured using handheld meter mmol/L | about every 3-7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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body composition, exercise performance, keto-adaptation