Clinical Trials Directory

Trials / Completed

CompletedNCT03231514

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
59 (actual)
Sponsor
Texas Woman's University · Academic / Other
Sex
All
Age
18 Years – 30 Years
Healthy volunteers
Accepted

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).

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTCarbohydrate Supplement (Carb10)2 of 4 arms will be supplemented with carbohydrate pre-workout (Carb10, Compound Solutions, Carlsbad, CA)
OTHERDiet2 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)
OTHERExerciseAll groups will participate in a standardized exercise intervention.

Timeline

Start date
2017-01-01
Primary completion
2017-12-01
Completion
2017-12-01
First posted
2017-07-27
Last updated
2018-02-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03231514. Inclusion in this directory is not an endorsement.