Intense ExerciseNCT01581190
Bananas as an Energy Source During Exercise: a Metabolomics Approach
A study testing Bananas versus 6% carbohydrate beverage in people with Intense Exercise, run by Appalachian State University at 1 site in United States.
Trial summary
This study compared the acute effect of ingesting bananas (BAN) versus a 6% carbohydrate drink (CHO) on 75-km cycling performance and post-exercise inflammation, oxidative stress, and innate immune function using traditional and metabolomics-based profiling. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Intense Exercise
- What is being tested?
- Bananas versus 6% carbohydrate beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Nov 2011
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Ages 18-45 years
- Cyclists, road racing experience.
- Willing to avoid the use of supplements, herbs, medications during the study.
Who cannot join
- Female
- Over the age of 45 years
- No cycling racing experience
- Using supplements and medications during the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Performance Lab, North Carolina Research Campus
Kannapolis, North Carolina, 28081
About this study
Official title: Comparison of Bananas and Gatorade on Performance and Exercise-induced Inflammation, Oxidative Stress, and Changes in Immune Function in Endurance Athletes
This study compared the acute effect of ingesting bananas (BAN) versus a 6% carbohydrate drink (CHO) on 75-km cycling performance and post-exercise inflammation, oxidative stress, and innate immune function using traditional and metabolomics-based profiling.
Read the detailed description
Trained cyclists (N=14) completed two 75-km cycling time trials (randomized, crossover) while ingesting BAN or CHO (0.2 g/kg carbohydrate every 15 min). Pre-, post-, and 1-h-post-exercise blood samples were analyzed for glucose, granulocyte (GR) and monocyte (MO) phagocytosis (PHAG) and oxidative burst activity, nine cytokines, F2-isoprostanes, ferric reducing ability of plasma (FRAP), and metabolic profiles using gas chromatography-mass spectrometry.
- Conditions
- Intense Exercise
- Being tested
- Bananas versus 6% carbohydrate beverage
- Keywords
- Bananas, Exercise, Metabolomics, Oxidative stress, Inflammation, Immune function
- Medical subject headings
- Motor Activity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bananas versus 6% carbohydrate beverageDietary supplement
Also called Gatorade
Trained cyclists (N=14) completed two 75-km cycling time trials (randomized, crossover) while ingesting BAN or CHO (0.2 g/kg carbohydrate every 15 min).
| Study group | Role | What they receive |
|---|---|---|
| Bananas versus 6% carbohydrate beverage | Experimental | Not described Receives: Dietary Supplement: Bananas versus 6% carbohydrate beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance and fuel substrate utilization as measured through metabolomics
Will measure shifts in metabolites following 75-km cycling while ingesting bananas or 6% carbohydrate beverage. The shift in metabolites will be assessed using GC-MS. Time frame from date of randomization until the last samples are collected and analyzed will be up to six months.
Measured: Up to 6 months
Secondary outcomes (1)
Exercise-induced inflammation.
Cytokine panel (IL-6, IL-8, IL-10, TNF-alpha) before and after cycling 75-km; measured with Meso Scale Discovery in pg/ml. Time frame from randomization until the last samples are collected and analyzed will be up to six months.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startSep 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intense ExerciseStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Appalachian State University
- Sponsor type
- University, hospital or other
- Collaborators
- Dole Food Company
- Responsible party
- Principal investigator, David C. Nieman, Appalachian State University
- Investigators
- David C Nieman, DrPH, Principal investigator, Appalachian State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01581190
- Sponsor's protocol ID
- 11-0082
- Status last verified
- Apr 2012
- First submitted
- 14 Apr 2012
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bananas and Gatorade on Performance and Exercise-induced Inflammation, Oxidative Stress, and Changes in Immune Function in Endurance Athletes
- ClinicalTrials.gov ID
- NCT01581190
- Acronym / sponsor ID
- 11-0082
- Conditions
- Intense Exercise
- Keywords
- Bananas, Exercise, Metabolomics, Oxidative stress, Inflammation, Immune function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Appalachian State UniversityUniversity, hospital or other
- Collaborators
- Dole Food Company
- Study start
- Sep 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 20 Apr 2012 (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.
This study compared the acute effect of ingesting bananas (BAN) versus a 6% carbohydrate drink (CHO) on 75-km cycling performance and post-exercise inflammation, oxidative stress, and innate immune function using traditional and metabolomics-based profiling.
Detailed description
Trained cyclists (N=14) completed two 75-km cycling time trials (randomized, crossover) while ingesting BAN or CHO (0.2 g/kg carbohydrate every 15 min). Pre-, post-, and 1-h-post-exercise blood samples were analyzed for glucose, granulocyte (GR) and monocyte (MO) phagocytosis (PHAG) and oxidative burst activity, nine cytokines, F2-isoprostanes, ferric reducing ability of plasma (FRAP), and metabolic profiles using gas chromatography-mass spectrometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bananas versus 6% carbohydrate beverage | Experimental | Dietary Supplement: Bananas versus 6% carbohydrate beverage |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male
- Ages 18-45 years
- Cyclists, road racing experience.
- Willing to avoid the use of supplements, herbs, medications during the study.
Key exclusion criteria (4 listed)
- Female
- Over the age of 45 years
- No cycling racing experience
- Using supplements and medications during the study
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 |
|---|---|---|
| Bananas versus 6% carbohydrate beverageAlso: GatoradeTrained cyclists (N=14) completed two 75-km cycling time trials (randomized, crossover) while ingesting BAN or CHO (0.2 g/kg carbohydrate every 15 min). | Dietary supplement | Bananas versus 6% carbohydrate beverage |
Primary outcome
Performance and fuel substrate utilization as measured through metabolomics
Time frame: Up to 6 months
Will measure shifts in metabolites following 75-km cycling while ingesting bananas or 6% carbohydrate beverage. The shift in metabolites will be assessed using GC-MS. Time frame from date of randomization until the last samples are collected and analyzed will be up to six months.
1 secondary outcome
Exercise-induced inflammation.
Time frame: up to 6 months
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 20 Apr 2012.
- Website for labLink 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.
David C Nieman, DrPH principal investigator
Appalachian State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bananas versus 6% carbohydrate beverage in people with Intense Exercise, run by Appalachian State University 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 4 inclusion and 4 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 20 Apr 2012. 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?
Performance and fuel substrate utilization as measured through metabolomics (time frame: Up to 6 months). 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 20 Apr 2012.