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Carbohydrate-Protein Supplementation During Endurance Running

This study has been completed.
Sponsor:
Information provided by:
University of Tennessee
ClinicalTrials.gov Identifier:
NCT00972387
First received: September 3, 2009
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Supplementation During Endurance Performance
Dietary Supplement: CHO, CHO-P, CHO-CHO, PLA
Dietary Supplement: CHO-P, CHO-CHO, PLA, CHO
Dietary Supplement: CHO-CHO, PLA, CHO, CHO-P
Dietary Supplement: PLA, CHO, CHO-P, CHO-CHO

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: "Nutritional Ergogenic Aids: The Effects of Carbohydrate-Protein Supplementation During Endurance Exercise"

Resource links provided by NLM:


Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • Time it takes to complete each 12-mile time trial run [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • Time it takes to complete the 1.6 mile maximal effort at the end of the 12 mile run. [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart Rate at the beginning of each time trial, start of the maximal effort, end of the run. [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • Rating of perceived exertion through out the duration of the 12 mile time trial run. [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: August 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972387

Locations
United States, Tennessee
Health Physical Education and Recreation Building
Knoxville, Tennessee, United States, 37996
Sponsors and Collaborators
University of Tennessee
Investigators
Study Chair: Hollie A Raynor, PhD University of Tennessee, Knoxville
  More Information

Additional Information:
No publications provided

Responsible Party: Adriana Coletta, B.S., Healthy Eating and Activity Laboratory- University of Tennessee
ClinicalTrials.gov Identifier: NCT00972387     History of Changes
Other Study ID Numbers: University of TN IRB 7959-B
Study First Received: September 3, 2009
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Tennessee:
carbohydrate-protein
endurance exercise
supplement

ClinicalTrials.gov processed this record on November 27, 2014