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

February 16, 2018 updated by: Jordan Joy, Texas Woman's University
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."

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Denton, Texas, United States, 76204
        • Texas Woman's University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Carbohydrate Diet & Placebo & Exercise
This group receives the carbohydrate-based diet and flavored placebo pre-workout drink. All participate in the exercise intervention.
Other: Exercise
All groups will participate in a standardized exercise intervention.
Active Comparator: 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.
Other: Exercise
All groups will participate in a standardized exercise intervention.
Dietary supplement: Carbohydrate Supplement (Carb10)
2 of 4 arms will be supplemented with carbohydrate pre-workout (Carb10, Compound Solutions, Carlsbad, CA)
Experimental: 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.
Other: Exercise
All groups will participate in a standardized exercise intervention.
Other: 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)
Experimental: Ketogenic Diet & Carbohydrate Supplement (Carb10) & Exercise
This group receives the ketogenic diet and supplemental carbohydrate. All participate in the exercise intervention.
Other: Exercise
All groups will participate in a standardized exercise intervention.
Dietary supplement: Carbohydrate Supplement (Carb10)
2 of 4 arms will be supplemented with carbohydrate pre-workout (Carb10, Compound Solutions, Carlsbad, CA)
Other: 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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Body Composition
Time Frame: 0 and 10 weeks
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
Time Frame: 0 and 10 weeks
Will be measured as peak and average power output in Watts during a repeated Wingate sprint test
0 and 10 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Body Composition
Time Frame: 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
0 and 10 weeks
Change in Body Water
Time Frame: 0 and 10 weeks
BIS determined total, intra-, and extra-cellular fluid in Liters
0 and 10 weeks
Change in Cross-sectional Area
Time Frame: 0 and 10 weeks
B-mode ultrasound determined cross-sectional area of the rectus femoris in cm squared
0 and 10 weeks
Change in Muscle Thickness
Time Frame: 0 and 10 weeks
B-mode ultrasound determined combined thickness of the vastus lateralis and vastus medius in cm
0 and 10 weeks
Change in Aerobic Performance
Time Frame: 0 and 10 weeks
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
Time Frame: 0 and 10 weeks
measured using vertec
0 and 10 weeks
Change in Vertical Jump Power
Time Frame: 0 and 10 weeks
measured using linear force transducer
0 and 10 weeks
Change in Vertical Jump Velocity
Time Frame: 0 and 10 weeks
measured using linear force transducer
0 and 10 weeks
Change in Vertical Jump Force
Time Frame: 0 and 10 weeks
measured using linear force transducer
0 and 10 weeks
Change in Strength
Time Frame: 0 and 10 weeks
measured as 1 repetition maximum
0 and 10 weeks
Change in Insulin
Time Frame: 0 and 10 weeks
measured using clinical analyzer pmol/L
0 and 10 weeks
Change in HDL
Time Frame: 0 and 10 weeks
measured using clinical analyzer mg/dL
0 and 10 weeks
Changes in LDL
Time Frame: 0 and 10 weeks
measured using clinical analyzer mg/dL
0 and 10 weeks
Changes in Triglycerides
Time Frame: 0 and 10 weeks
measured using clinical analyzer mg/dL
0 and 10 weeks
Changes in Aspartate Amino Transferase
Time Frame: 0 and 10 weeks
measured using clinical analyzer U/L
0 and 10 weeks
Changes in Alanine amino Transferase
Time Frame: 0 and 10 weeks
measured using clinical analyzer U/L
0 and 10 weeks
Changes in HbA1C
Time Frame: 0 and 10 weeks
measured using clinical analyzer mmol/mol
0 and 10 weeks
Changes in Creatine Kinase
Time Frame: 0 and 10 weeks
measured using clinical analyzer U/L
0 and 10 weeks
Changes in Total Testosterone
Time Frame: 0 and 10 weeks
measured using ELISA ng/dL
0 and 10 weeks
Changes in Free Testosterone
Time Frame: 0 and 10 weeks
measured using ELISA ng/dL
0 and 10 weeks
Changes in Total Estrogens
Time Frame: 0 and 10 weeks
measured using ELISA pg/mL
0 and 10 weeks
Changes in Triiodothyronine
Time Frame: 0 and 10 weeks
measured using ELISA ng/dL
0 and 10 weeks
Changes in Thyroxine
Time Frame: 0 and 10 weeks
measured using ELISA ng/dL
0 and 10 weeks
Changes in Thyroid Stimulating Hormone
Time Frame: 0 and 10 weeks
measured using ELISA mu/L
0 and 10 weeks
changes in C-reactive Protein
Time Frame: 0 and 10 weeks
measured using ELISA mg/L
0 and 10 weeks
Changes in Dehydroepiandrosterone sulfate
Time Frame: 0 and 10 weeks
measured using ELISA ug/dL
0 and 10 weeks
Changes in Sex hormone Binding Globulin
Time Frame: 0 and 10 weeks
measured using ELISA nmol/L
0 and 10 weeks
Changes in Cortisol
Time Frame: 0 and 10 weeks
measured using ELISA ug/dL
0 and 10 weeks
Changes in Whole Blood Betahydroxybutyrate
Time Frame: about every 3-7 days
measured using handheld meter mmol/L
about every 3-7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas Woman's University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Compound Solutions Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jordan Joy, MS, Texas Woman's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19151

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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