NCT01581190

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2011

Shorter than P25 for not_applicable

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

September 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2012

Completed
Last Updated

April 20, 2012

Status Verified

April 1, 2012

Enrollment Period

2 months

First QC Date

April 14, 2012

Last Update Submit

April 18, 2012

Conditions

Intense Exercise

Keywords

BananasExerciseMetabolomicsOxidative stressInflammationImmune function

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 6 months

Secondary Outcomes (1)

  • Exercise-induced inflammation.

    up to 6 months

Study Arms (1)

Bananas versus 6% carbohydrate beverage

EXPERIMENTAL
Dietary Supplement: Bananas versus 6% carbohydrate beverage

Interventions

Bananas versus 6% carbohydrate beverageDIETARY_SUPPLEMENT

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).

Also known as: Gatorade
Bananas versus 6% carbohydrate beverage

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Ages 18-45 years
  • Cyclists, road racing experience.
  • Willing to avoid the use of supplements, herbs, medications during the study.

You may not qualify if:

  • Female
  • Over the age of 45 years
  • No cycling racing experience
  • Using supplements and medications during the study

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 Links

MeSH Terms

Conditions

Motor ActivityInflammation

Interventions

gatorade

Condition Hierarchy (Ancestors)

BehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David C Nieman, DrPH

    Appalachian State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Director of the Human Performance Lab

Study Record Dates

First Submitted

April 14, 2012

First Posted

April 20, 2012

Study Start

September 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

April 20, 2012

Record last verified: 2012-04

Locations

US(1)