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

Not Applicable

Completed

• Conditions: Ketogenic Dieting
• Interventions: Other: Diet; Dietary Supplement: Carbohydrate Supplement (Carb10); Other: Exercise

• Registration Number: NCT03231514
• Lead Sponsor: Texas Woman's University

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).

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-07-12
• Study First Submitted QC: 2017-07-24
• Study First Posted: 2017-07-27
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-16
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbohydrate Diet & Carbohydrate Supplement(Carb10) & Exercise	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.
Ketogenic Diet & Placebo & Exercise	Diet	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.
Ketogenic Diet & Carbohydrate Supplement (Carb10) & Exercise	Diet	This group receives the ketogenic diet and supplemental carbohydrate. All participate in the exercise intervention.
Carbohydrate Diet & Carbohydrate Supplement(Carb10) & Exercise	Carbohydrate Supplement (Carb10)	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.
Ketogenic Diet & Placebo & Exercise	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.
Carbohydrate Diet & Placebo & Exercise	Exercise	This group receives the carbohydrate-based diet and flavored placebo pre-workout drink. All participate in the exercise intervention.
Ketogenic Diet & Carbohydrate Supplement (Carb10) & Exercise	Carbohydrate Supplement (Carb10)	This group receives the ketogenic diet and supplemental carbohydrate. All participate in the exercise intervention.
Ketogenic Diet & Carbohydrate Supplement (Carb10) & Exercise	Exercise	This group receives the ketogenic diet and supplemental carbohydrate. All participate in the exercise intervention.

Primary Outcome Measures

Name	Time	Method
Change in Body Composition	0 and 10 weeks	Will be measured as fat and lean soft tissue mass in kg by dual x-ray absorptiometry (DXA)
Change in Anaerobic Cardiovascular Performance	0 and 10 weeks	Will be measured as peak and average power output in Watts during a repeated Wingate sprint test

Secondary Outcome Measures

Name	Time	Method
Change in Body Composition	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
Change in Body Water	0 and 10 weeks	BIS determined total, intra-, and extra-cellular fluid in Liters
Change in Cross-sectional Area	0 and 10 weeks	B-mode ultrasound determined cross-sectional area of the rectus femoris in cm squared
Change in Muscle Thickness	0 and 10 weeks	B-mode ultrasound determined combined thickness of the vastus lateralis and vastus medius in cm
Change in Aerobic Performance	0 and 10 weeks	measured as a 5km time trial with a 250m hill segment (8% grade) at 1km and 4km on a treadmill
Change in Vertical Jump Height	0 and 10 weeks	measured using vertec
Change in Vertical Jump Power	0 and 10 weeks	measured using linear force transducer
Change in Vertical Jump Velocity	0 and 10 weeks	measured using linear force transducer
Change in Vertical Jump Force	0 and 10 weeks	measured using linear force transducer
Change in Strength	0 and 10 weeks	measured as 1 repetition maximum
Change in Insulin	0 and 10 weeks	measured using clinical analyzer pmol/L
Change in HDL	0 and 10 weeks	measured using clinical analyzer mg/dL
Changes in LDL	0 and 10 weeks	measured using clinical analyzer mg/dL
Changes in Triglycerides	0 and 10 weeks	measured using clinical analyzer mg/dL
Changes in Aspartate Amino Transferase	0 and 10 weeks	measured using clinical analyzer U/L
Changes in Alanine amino Transferase	0 and 10 weeks	measured using clinical analyzer U/L
Changes in HbA1C	0 and 10 weeks	measured using clinical analyzer mmol/mol
Changes in Creatine Kinase	0 and 10 weeks	measured using clinical analyzer U/L
Changes in Total Testosterone	0 and 10 weeks	measured using ELISA ng/dL
Changes in Total Estrogens	0 and 10 weeks	measured using ELISA pg/mL
Changes in Triiodothyronine	0 and 10 weeks	measured using ELISA ng/dL
Changes in Thyroxine	0 and 10 weeks	measured using ELISA ng/dL
Changes in Thyroid Stimulating Hormone	0 and 10 weeks	measured using ELISA mu/L
changes in C-reactive Protein	0 and 10 weeks	measured using ELISA mg/L
Changes in Dehydroepiandrosterone sulfate	0 and 10 weeks	measured using ELISA ug/dL
Changes in Sex hormone Binding Globulin	0 and 10 weeks	measured using ELISA nmol/L
Changes in Cortisol	0 and 10 weeks	measured using ELISA ug/dL
Changes in Whole Blood Betahydroxybutyrate	about every 3-7 days	measured using handheld meter mmol/L
Changes in Free Testosterone	0 and 10 weeks	measured using ELISA ng/dL

Trial Locations

Locations (1)

Texas Woman's University; 🇺🇸 Denton, Texas, United States