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

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Texas Woman's University

Status

Completed

Conditions

Ketogenic Dieting

Treatments

Dietary Supplement: Carbohydrate Supplement (Carb10)
Other: Exercise
Other: Diet

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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."

Full 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).

Enrollment

59 patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

59 participants in 4 patient groups, including a placebo group

Carbohydrate Diet & Placebo & Exercise
Placebo Comparator group
Description:
This group receives the carbohydrate-based diet and flavored placebo pre-workout drink. All participate in the exercise intervention.
Treatment:
Other: Exercise
Carbohydrate Diet & Carbohydrate Supplement(Carb10) & Exercise
Active Comparator group
Description:
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.
Treatment:
Dietary Supplement: Carbohydrate Supplement (Carb10)
Other: Exercise
Ketogenic Diet & Placebo & Exercise
Experimental group
Description:
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.
Treatment:
Other: Exercise
Other: Diet
Ketogenic Diet & Carbohydrate Supplement (Carb10) & Exercise
Experimental group
Description:
This group receives the ketogenic diet and supplemental carbohydrate. All participate in the exercise intervention.
Treatment:
Dietary Supplement: Carbohydrate Supplement (Carb10)
Other: Exercise
Other: Diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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