NCT02994628

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

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

November 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 16, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2017

Completed
Last Updated

February 23, 2017

Status Verified

January 1, 2016

Enrollment Period

1.1 years

First QC Date

November 24, 2015

Last Update Submit

February 18, 2017

Conditions

Keywords

oxidative stressimmune functionmuscle damagecarbohydratepolyphenolscycling

Outcome Measures

Primary Outcomes (1)

  • Change in total plasma concentrations of inflammatory cytokines

    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).

    Pre-exercise, and post-exercise (0, 0.75, 1.5, 3.0, 4.5, 21, 45 hours)

Secondary Outcomes (6)

  • Change in concentration of serum myoglobin

    Pre-exercise, and post-exercise (0, 0.75, 1.5, 3.0, 4.5, 21, 45 hours)

  • Change in muscle concentration of glycogen

    Pre-exercise, and post-exercise (0 hours)

  • Change in self-reported gastrointestinal and mental symptoms from a short questionnaire

    Pre-exercise, and post-exercise (0 hours)

  • Change in concentration of ferric reducing ability of plasma (FRAP)

    Pre-exercise, and post-exercise (0, 0.75, 1.5, 3.0, 4.5, 21, 45 hours)

  • Change in plasma concentration of oxidized low density lipoprotein

    Pre-exercise, and post-exercise (0, 0.75, 1.5, 3.0, 4.5, 21, 45 hours)

  • +1 more secondary outcomes

Study Arms (4)

Water

ACTIVE COMPARATOR

Intervention, water and no banana carbohydrate: consume 3 ml/kg water every 15 min during 75 km cycling

Other: Water

Mini banana

EXPERIMENTAL

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

Cavendish banana

EXPERIMENTAL

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

6% sugar beverage

EXPERIMENTAL

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

Interventions

WaterOTHER

Water only without carbohydrate

Water

Ingest mini banana containing higher phenolics and carbohydrate concentration

Mini banana

Ingest Cavendish banana (common banana)

Cavendish banana

Ingest 6% sugar beverage containing same glucose and fructose profile as banana

6% sugar beverage

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Performance Lab, North Carolina Research Campus

Kannapolis, North Carolina, 28081, United States

Location

Related Publications (3)

  • Nieman DC, Gillitt ND, Sha W, Meaney MP, John C, Pappan KL, Kinchen JM. Metabolomics-Based Analysis of Banana and Pear Ingestion on Exercise Performance and Recovery. J Proteome Res. 2015 Dec 4;14(12):5367-77. doi: 10.1021/acs.jproteome.5b00909. Epub 2015 Nov 23.

    PMID: 26561314BACKGROUND
  • Nieman DC, Gillitt ND, Chen GY, Zhang Q, Sakaguchi CA, Stephan EH. Carbohydrate intake attenuates post-exercise plasma levels of cytochrome P450-generated oxylipins. PLoS One. 2019 Mar 18;14(3):e0213676. doi: 10.1371/journal.pone.0213676. eCollection 2019.

  • Nieman DC, Gillitt ND, Sha W, Esposito D, Ramamoorthy S. Metabolic recovery from heavy exertion following banana compared to sugar beverage or water only ingestion: A randomized, crossover trial. PLoS One. 2018 Mar 22;13(3):e0194843. doi: 10.1371/journal.pone.0194843. eCollection 2018.

MeSH Terms

Conditions

Inflammation

Interventions

Water

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • David C. Nieman, DrPH

    Appalachian State University, North Carolina Research Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2015

First Posted

December 16, 2016

Study Start

November 1, 2015

Primary Completion

December 1, 2016

Study Completion

January 25, 2017

Last Updated

February 23, 2017

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will share

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.

Locations