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

NCT ID: NCT03231514

Last Updated: 2018-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-12-31

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).

Conditions

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Ketogenic Dieting

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Semi-randomized, parallel-group, single-blind diet and exercise intervention
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
Participants are blinded to the pre-workout drink content.

Study Groups

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Carbohydrate Diet & Placebo & Exercise

This group receives the carbohydrate-based diet and flavored placebo pre-workout drink. All participate in the exercise intervention.

Group Type PLACEBO_COMPARATOR

Exercise

Intervention Type OTHER

All groups will participate in a standardized exercise intervention.

Carbohydrate Diet & Carbohydrate Supplement(Carb10) & 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.

Group Type ACTIVE_COMPARATOR

Carbohydrate Supplement (Carb10)

Intervention Type DIETARY_SUPPLEMENT

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

Exercise

Intervention Type OTHER

All groups will participate in a standardized exercise intervention.

Ketogenic Diet & Placebo & 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.

Group Type EXPERIMENTAL

Diet

Intervention Type 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

Intervention Type OTHER

All groups will participate in a standardized exercise intervention.

Ketogenic Diet & Carbohydrate Supplement (Carb10) & Exercise

This group receives the ketogenic diet and supplemental carbohydrate. All participate in the exercise intervention.

Group Type EXPERIMENTAL

Carbohydrate Supplement (Carb10)

Intervention Type DIETARY_SUPPLEMENT

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

Diet

Intervention Type 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

Intervention Type OTHER

All groups will participate in a standardized exercise intervention.

Interventions

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Carbohydrate Supplement (Carb10)

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

Intervention Type DIETARY_SUPPLEMENT

Diet

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)

Intervention Type OTHER

Exercise

All groups will participate in a standardized exercise intervention.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Compound Solutions Inc.

INDUSTRY

Sponsor Role collaborator

Texas Woman's University

OTHER

Sponsor Role lead

Responsible Party

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Jordan Joy

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jordan Joy, MS

Role: PRINCIPAL_INVESTIGATOR

Texas Woman's University

Locations

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Texas Woman's University

Denton, Texas, United States

Site Status

Countries

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United States

References

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Volek JS, Freidenreich DJ, Saenz C, Kunces LJ, Creighton BC, Bartley JM, Davitt PM, Munoz CX, Anderson JM, Maresh CM, Lee EC, Schuenke MD, Aerni G, Kraemer WJ, Phinney SD. Metabolic characteristics of keto-adapted ultra-endurance runners. Metabolism. 2016 Mar;65(3):100-10. doi: 10.1016/j.metabol.2015.10.028. Epub 2015 Nov 2.

Reference Type BACKGROUND
PMID: 26892521 (View on PubMed)

Wilson JM, Lowery RP, Roberts MD, Sharp MH, Joy JM, Shields KA, Partl JM, Volek JS, D'Agostino DP. Effects of Ketogenic Dieting on Body Composition, Strength, Power, and Hormonal Profiles in Resistance Training Men. J Strength Cond Res. 2020 Dec;34(12):3463-3474. doi: 10.1519/JSC.0000000000001935.

Reference Type BACKGROUND
PMID: 28399015 (View on PubMed)

Burke LM, Ross ML, Garvican-Lewis LA, Welvaert M, Heikura IA, Forbes SG, Mirtschin JG, Cato LE, Strobel N, Sharma AP, Hawley JA. Low carbohydrate, high fat diet impairs exercise economy and negates the performance benefit from intensified training in elite race walkers. J Physiol. 2017 May 1;595(9):2785-2807. doi: 10.1113/JP273230. Epub 2017 Feb 14.

Reference Type BACKGROUND
PMID: 28012184 (View on PubMed)

Urbain P, Strom L, Morawski L, Wehrle A, Deibert P, Bertz H. Impact of a 6-week non-energy-restricted ketogenic diet on physical fitness, body composition and biochemical parameters in healthy adults. Nutr Metab (Lond). 2017 Feb 20;14:17. doi: 10.1186/s12986-017-0175-5. eCollection 2017.

Reference Type BACKGROUND
PMID: 28239404 (View on PubMed)

Other Identifiers

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19151

Identifier Type: -

Identifier Source: org_study_id

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