Carbohydrate-Protein Supplementation During Endurance Running

April 3, 2018 updated by: Hollie Raynor, The University of Tennessee, Knoxville

"Nutritional Ergogenic Aids: The Effects of Carbohydrate-Protein Supplementation During Endurance Exercise"

The purpose of this study is to assess whether the greater performance benefits from ingesting carbohydrate-protein supplements during endurance running, in comparison to the traditionally used carbohydrate supplement, is attributed to the extra calories contained in the carbohydrate-protein supplement or the presence of protein.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to determine whether the performance benefits from consuming a carbohydrate-protein (CHO-P) supplement, such as Accelerade, during endurance exercise, as opposed to the traditionally used carbohydrate (CHO) supplement, such as Gatorade, are attributed to the extra calories in the CHO-P supplement or the presence of protein alone in comparison to CHO supplements. Numerous studies comparing CHO and CHO-P supplements on endurance performance have found contradicting results in terms of CHO-P supplementation and performance benefits. While physiological mechanisms have been proposed as to why the CHO-P supplements elicit greater performance, research has yet to determine why some studies have found this, especially while other studies have found no performance benefits from CHO-P supplementation. This inconsistency in research may be due to the caloric difference between supplements tested; due to the addition of protein, the CHO-P supplement contains more calories per serving than the CHO supplement. As a result, this study will be comparing 4 different supplements during endurance exercise, a CHO-P supplement, CHO supplement, a double carbohydrate supplement (CHO-CHO), and a placebo (PLA). The CHO and CHO-P supplement will be matched for CHO content, whereas the CHO-P and CHO-CHO supplements will be matched for total caloric content. Participants will be asked to run four 12-mile runs on 4 separate occasions, approximately 7-10 days apart, and will be blinded to supplement content and order of supplement administration among trials. The 12-mile run will elicit an exercise bout greater than 60 minutes, which is relevant when supplementing exercise with CHO or CHO-P. Performance will be assessed via time it takes to complete both the 12-mile run and the 1.6 mile maximal effort at the end of the run.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • 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
    • Tennessee
      • Knoxville, Tennessee, United States, 37996
        • Health Physical Education and Recreation Building

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

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Males aged 18-55 years old
  • BMI in the healthy range, 18.5-24.9
  • Run 45-90+ minutes at least 4 days per week
  • Engage in running this frequency and duration for at least 4 weeks prior to the phone screen
  • Engage in a run consisting ≥10 miles in length for at least 2-4 occasions per month for at least 2 months prior to the phone screen
  • No previous history of heart conditions
  • No shortness of breath or chest pain experienced during running or daily activities
  • No bone or joint problems experienced during running or daily activities

Exclusion Criteria:

  • Females and males under the age of 18 and over the age of 55
  • Females are excluded from this study in order to prevent any potential factors associated with the female athlete triad and endurance performance outcomes.
  • BMI below 18.5 or greater than 24.9
  • Does not meet all other criteria listed (#3-6)
  • Allergies to products containing milk, soy, or aspartame
  • Severe allergies to eggs, wheat, tree nuts, fish, crustaceans, shellfish products (Accelerade, the CHO-P supplement, is made in a facility that processed these products)
  • Refusal to consume any of the supplements, and/or extreme dislike of the supplements
  • Refusal to complete the specified distance of the time trials

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: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Order 1
Supplement order for each time trial run, 1-4 respectively: CHO, CHO-P, CHO-CHO, PLA
Dietary supplement: CHO, CHO-P, CHO-CHO, PLA
The CHO supplement will be administered during trial 1. The CHO-P will be administered during trial 2. The CHO-CHO supplement will be administered during trial 3. The PLA supplement will be administered during trial 4. This is the order of supplement administration for subjects randomly assigned to this order group.
Active Comparator: Order 2
Supplement order for each time trial run, 1-4 respectively: CHO-P, CHO-CHO, PLA, CHO
Dietary supplement: CHO-P, CHO-CHO, PLA, CHO
The CHO-P supplement will be administered during trial 1. The CHO-CHO will be administered during trial 2. The PLA supplement will be administered during trial 3. The CHO supplement will be administered during trial 4. This is the order of supplement administration for subjects randomly assigned to this order group.
Active Comparator: Order 3
Supplement order for each time trial run, 1-4 respectively: CHO-CHO, PLA, CHO, CHO-P
Dietary supplement: CHO-CHO, PLA, CHO, CHO-P
The CHO-CHO supplement will be administered during trial 1. The PLA will be administered during trial 2. The CHO supplement will be administered during trial 3. The CHO-P supplement will be administered during trial 4. This is the order of supplement administration for subjects randomly assigned to this order group.
Active Comparator: Order 4
Supplement order for each time trial run, 1-4 respectively: PLA, CHO, CHO-P, CHO-CHO
Dietary supplement: PLA, CHO, CHO-P, CHO-CHO
The PLA supplement will be administered during trial 1. The CHO will be administered during trial 2. The CHO-P supplement will be administered during trial 3. The CHO-CHO supplement will be administered during trial 4. This is the order of supplement administration for subjects randomly assigned to this order group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time it takes to complete each 12-mile time trial run
Time Frame: 4 days
4 days
Time it takes to complete the 1.6 mile maximal effort at the end of the 12 mile run.
Time Frame: 4 days
4 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Heart Rate at the beginning of each time trial, start of the maximal effort, end of the run.
Time Frame: 4 days
4 days
Rating of perceived exertion through out the duration of the 12 mile time trial run.
Time Frame: 4 days
4 days

Collaborators and Investigators

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

Sponsor

The University of Tennessee, Knoxville

Investigators

  • Study Chair: Hollie A Raynor, PhD, University of Tennessee, Knoxville

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.

Helpful Links

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

August 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

September 3, 2009

First Submitted That Met QC Criteria

September 3, 2009

First Posted (Estimate)

September 4, 2009

Study Record Updates

Last Update Posted (Actual)

April 5, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • University of TN IRB 7959-B

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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