NCT00972387

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 4, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

8 months

First QC Date

September 3, 2009

Last Update Submit

April 3, 2018

Conditions

Keywords

carbohydrate-proteinendurance exercisesupplement

Outcome Measures

Primary Outcomes (2)

  • Time it takes to complete each 12-mile time trial run

    4 days

  • Time it takes to complete the 1.6 mile maximal effort at the end of the 12 mile run.

    4 days

Secondary Outcomes (2)

  • Heart Rate at the beginning of each time trial, start of the maximal effort, end of the run.

    4 days

  • Rating of perceived exertion through out the duration of the 12 mile time trial run.

    4 days

Study Arms (4)

Order 1

ACTIVE COMPARATOR

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

Dietary Supplement: CHO, CHO-P, CHO-CHO, PLA

Order 2

ACTIVE COMPARATOR

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

Dietary Supplement: CHO-P, CHO-CHO, PLA, CHO

Order 3

ACTIVE COMPARATOR

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

Dietary Supplement: CHO-CHO, PLA, CHO, CHO-P

Order 4

ACTIVE COMPARATOR

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

Dietary Supplement: PLA, CHO, CHO-P, CHO-CHO

Interventions

CHO, CHO-P, CHO-CHO, PLADIETARY_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 1
CHO-P, CHO-CHO, PLA, CHODIETARY_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 2
CHO-CHO, PLA, CHO, CHO-PDIETARY_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 3
PLA, CHO, CHO-P, CHO-CHODIETARY_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.

Order 4

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Physical Education and Recreation Building

Knoxville, Tennessee, 37996, United States

Location

Related Links

Study Officials

  • Hollie A Raynor, PhD

    University of Tennessee, Knoxville

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 3, 2009

First Posted

September 4, 2009

Study Start

August 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations