Supplementation During Endurance PerformanceNCT00972387
Carbohydrate-Protein Supplementation During Endurance Running
A study testing CHO, CHO-P, CHO-CHO, PLA, CHO-P, CHO-CHO, PLA, CHO and CHO-CHO, PLA, CHO, CHO-P in people with Supplementation During Endurance Performance, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Supplementation During Endurance Performance
- What is being tested?
- CHO, CHO-P, CHO-CHO, PLA, CHO-P, CHO-CHO, PLA, CHO and CHO-CHO, PLA, CHO, CHO-P
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Health Physical Education and Recreation Building
Knoxville, Tennessee, 37996
About this study
Official title: "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.
Read the 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.
- Being tested
- CHO, CHO-P, CHO-CHO, PLA, CHO-P, CHO-CHO, PLA, CHO, CHO-CHO, PLA, CHO, CHO-P, PLA, CHO, CHO-P, CHO-CHO
- Keywords
- carbohydrate-protein, endurance exercise, supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Order 1 | Active comparator | Supplement order for each time trial run, 1-4 respectively: CHO, CHO-P, CHO-CHO, PLA Receives: 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 Receives: 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 Receives: 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 Receives: Dietary Supplement: PLA, CHO, CHO-P, CHO-CHO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time it takes to complete each 12-mile time trial run
Measured: 4 days
Time it takes to complete the 1.6 mile maximal effort at the end of the 12 mile run.
Measured: 4 days
Secondary outcomes (2)
Heart Rate at the beginning of each time trial, start of the maximal effort, end of the run.
Measured: 4 days
Rating of perceived exertion through out the duration of the 12 mile time trial run.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supplementation During Endurance PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hollie Raynor, The University of Tennessee, Knoxville
- Investigators
- Hollie A Raynor, PhD, Study chair, University of Tennessee, Knoxville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972387
- Sponsor's protocol ID
- University of TN IRB 7959-B
- Status last verified
- Apr 2018
- First submitted
- 3 Sep 2009
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Nutritional Ergogenic Aids: The Effects of Carbohydrate-Protein Supplementation During Endurance Exercise"
- ClinicalTrials.gov ID
- NCT00972387
- Acronym / sponsor ID
- University of TN IRB 7959-B
- Keywords
- carbohydrate-protein, endurance exercise, supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 4 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Order 1 | Active comparator | Dietary Supplement: CHO, CHO-P, CHO-CHO, PLASupplement order for each time trial run, 1-4 respectively: CHO, CHO-P, CHO-CHO, PLA |
| Order 2 | Active comparator | Dietary Supplement: CHO-P, CHO-CHO, PLA, CHOSupplement order for each time trial run, 1-4 respectively: CHO-P, CHO-CHO, PLA, CHO |
| Order 3 | Active comparator | Dietary Supplement: CHO-CHO, PLA, CHO, CHO-PSupplement order for each time trial run, 1-4 respectively: CHO-CHO, PLA, CHO, CHO-P |
| Order 4 | Active comparator | Dietary Supplement: PLA, CHO, CHO-P, CHO-CHOSupplement order for each time trial run, 1-4 respectively: PLA, CHO, CHO-P, CHO-CHO |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHO, CHO-P, CHO-CHO, PLAThe 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. | Dietary supplement | Order 1 |
| CHO-P, CHO-CHO, PLA, CHOThe 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. | Dietary supplement | Order 2 |
| CHO-CHO, PLA, CHO, CHO-PThe 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. | Dietary supplement | Order 3 |
| PLA, CHO, CHO-P, CHO-CHOThe 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. | Dietary supplement | Order 4 |
Primary outcome
Time it takes to complete each 12-mile time trial run
Time frame: 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
2 secondary outcomes
Heart Rate at the beginning of each time trial, start of the maximal effort, end of the run.
Time frame: 4 days
Rating of perceived exertion through out the duration of the 12 mile time trial run.
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hollie A Raynor, PhD study chair
University of Tennessee, Knoxville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHO, CHO-P, CHO-CHO, PLA, CHO-P, CHO-CHO, PLA, CHO and CHO-CHO, PLA, CHO, CHO-P in people with Supplementation During Endurance Performance, run by The University of Tennessee, Knoxville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time it takes to complete each 12-mile time trial run (time frame: 4 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.