Carbohydrate-Protein Supplementation During Endurance Running

NCT ID: NCT00972387

Last Updated: 2018-04-05

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Supplementation During Endurance Performance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Order 1

Supplement order for each time trial run, 1-4 respectively: CHO, CHO-P, CHO-CHO, PLA

Group Type ACTIVE_COMPARATOR

CHO, CHO-P, CHO-CHO, PLA

Intervention Type DIETARY_SUPPLEMENT

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.

Order 2

Supplement order for each time trial run, 1-4 respectively: CHO-P, CHO-CHO, PLA, CHO

Group Type ACTIVE_COMPARATOR

CHO-P, CHO-CHO, PLA, CHO

Intervention Type DIETARY_SUPPLEMENT

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.

Order 3

Supplement order for each time trial run, 1-4 respectively: CHO-CHO, PLA, CHO, CHO-P

Group Type ACTIVE_COMPARATOR

CHO-CHO, PLA, CHO, CHO-P

Intervention Type DIETARY_SUPPLEMENT

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.

Order 4

Supplement order for each time trial run, 1-4 respectively: PLA, CHO, CHO-P, CHO-CHO

Group Type ACTIVE_COMPARATOR

PLA, CHO, CHO-P, CHO-CHO

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The University of Tennessee, Knoxville

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hollie Raynor

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hollie A Raynor, PhD

Role: STUDY_CHAIR

University of Tennessee, Knoxville

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Health Physical Education and Recreation Building

Knoxville, Tennessee, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

University of TN IRB 7959-B

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Protein Requirements in Endurance-trained Athlete
NCT02478801 COMPLETED EARLY_PHASE1