Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Banana Cultivars and Exercise Performance and Recovery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02994628
Recruitment Status : Completed
First Posted : December 16, 2016
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
Dole Food Company
Information provided by (Responsible Party):
Appalachian State University

Brief Summary:

In a previous study at the Appalachian State University (ASU) Human Performance Laboratory at the North Carolina Research Campus (NCRC), investigators showed that cyclists ingesting about one-half of a banana with water every 15 minutes cycled 75-km faster (5%) than with water alone. The polyphenols (i.e., chemicals in plants with health benefits) in the banana improved the capacity to counter oxidative stress, and the sugars lowered post-exercise inflammation. The cyclists reported some gastrointestinal discomfort, however, from the high volume of bananas consumed. Dole Foods, the sponsor of this study, has a banana collection that includes many different varieties, including the Mini banana that has a higher sugar (50%) and phenolic (63%) content than the typical banana (Cavendish) available in stores. Thus athletes should experience similar performance benefits from a smaller volume of Mini compared to Cavendish bananas, and reduced gastrointestinal symptoms. If study results are favorable, Dole Foods may market the Mini banana as the "sport" banana.

The purpose of this study is to compare ingestion of Mini and Cavendish bananas with an equicaloric, sugar-only beverage or water on 75-km cycling performance and post-exercise oxidative capacity and stress, inflammation, immune function, muscle damage and soreness, and gastrointestinal symptoms.


Condition or disease Intervention/treatment Phase
Inflammation Other: Water Other: Mini banana Other: Cavendish banana Other: 6% sugar beverage Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Bananas Varying in Carbohydrate and Phenolic Content on Exercise Performance and Recovery
Actual Study Start Date : November 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 25, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Water
Intervention, water and no banana carbohydrate: consume 3 ml/kg water every 15 min during 75 km cycling
Other: Water
Water only without carbohydrate

Experimental: Mini banana
Intervention, banana carbohydrate: ingest 0.2 g carbohydrate/kg body weight from Mini banana with 3 ml/kg water every 15 minutes during 75 km cycling
Other: Mini banana
Ingest mini banana containing higher phenolics and carbohydrate concentration

Experimental: Cavendish banana
Intervention, banana carbohydrate: ingest 0.2 g carbohydrate/kg body weight from Cavendish banana with 3 ml/kg water every 15 minutes during 75 km cycling
Other: Cavendish banana
Ingest Cavendish banana (common banana)

Experimental: 6% sugar beverage
Intervention: pure banana carbohydrate in sugar beverage; ingest 0.2 g carbohydrate/kg body weight from a 6% sugar beverage every 15 minutes during 75 km cycling (contains 60 grams sugar per liter using the same sugar profile found in Cavendish bananas)
Other: 6% sugar beverage
Ingest 6% sugar beverage containing same glucose and fructose profile as banana




Primary Outcome Measures :
  1. Change in total plasma concentrations of inflammatory cytokines [ Time Frame: Pre-exercise, and post-exercise (0, 0.75, 1.5, 3.0, 4.5, 21, 45 hours) ]
    Total plasma concentrations of five inflammatory cytokines [monocyte chemoattractant protein-1 (MCP-1), tumor necrosis factor alpha (TNFα), IL-6, IL-8, and IL-10] will be determined using an electrochemiluminescence based solid-phase sandwich immunoassay (Meso Scale Discovery, Gaithersburg,MD, USA).


Secondary Outcome Measures :
  1. Change in concentration of serum myoglobin [ Time Frame: Pre-exercise, and post-exercise (0, 0.75, 1.5, 3.0, 4.5, 21, 45 hours) ]
    muscle damage marker

  2. Change in muscle concentration of glycogen [ Time Frame: Pre-exercise, and post-exercise (0 hours) ]
    change in muscle glycogen using ultrasound

  3. Change in self-reported gastrointestinal and mental symptoms from a short questionnaire [ Time Frame: Pre-exercise, and post-exercise (0 hours) ]
    Gastrointestinal and mental symptoms, 1-12 Likert scale

  4. Change in concentration of ferric reducing ability of plasma (FRAP) [ Time Frame: Pre-exercise, and post-exercise (0, 0.75, 1.5, 3.0, 4.5, 21, 45 hours) ]
    total plasma antioxidant power

  5. Change in plasma concentration of oxidized low density lipoprotein [ Time Frame: Pre-exercise, and post-exercise (0, 0.75, 1.5, 3.0, 4.5, 21, 45 hours) ]
    oxidative stress

  6. Change in blood natural killer cell activity [ Time Frame: Pre-exercise, and post-exercise (0, 0.75, 1.5, 3.0, 4.5, 21, 45 hours) ]
    innate immune measure



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, with no known cardiovascular disease, diabetes, or cancer.
  • Non-smoker.
  • Regularly compete in road races (category 1 to 5) and/or capable of cycling 75 km in a laboratory setting (using own bicycles on CompuTrainer training systems).
  • Agree to train normally, maintain weight, and avoid the regular use of large-dose vitamin and mineral supplements, herbs, and medications that influence inflammation and immune function (in particular, Advil, Motrin, aspirin and similar anti-inflammatory drugs) for the duration of the 7 to 8-week study. If in doubt, discuss supplement/medication use with the Research Manager.
  • Categorized as "low risk" using the American College of Sports Medicine screening questionnaire.

Exclusion Criteria:

  • Inability to comply with study requirements.
  • Any other concurrent condition which, in the opinion of the primary investigator (PI), would preclude participation in this study or interfere with compliance.
  • Current diagnosis of cardiovascular disease, diabetes, or cancer (except for non-melanoma skin cancer).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994628


Locations
Layout table for location information
United States, North Carolina
Human Performance Lab, North Carolina Research Campus
Kannapolis, North Carolina, United States, 28081
Sponsors and Collaborators
Appalachian State University
Dole Food Company
Investigators
Layout table for investigator information
Principal Investigator: David C. Nieman, DrPH Appalachian State University, North Carolina Research Campus
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Appalachian State University
ClinicalTrials.gov Identifier: NCT02994628    
Other Study ID Numbers: 16-0071
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared through the Human Metabolome Database (HMDB) or the Scripps Metabolite and Tandem MS Database (METLIN)], other public web sites, and publication in the scientific literature. We will cooperate in making available cloud-based access to the data and associated informatics components within the general scientific community.
Keywords provided by Appalachian State University:
oxidative stress
immune function
muscle damage
carbohydrate
polyphenols
cycling
Additional relevant MeSH terms:
Layout table for MeSH terms
Inflammation
Pathologic Processes