NCT02160873

Brief Summary

The purpose of this study is to investigate the influence of a nighttime feeding on next morning running performance, hydration status, and exercise metabolism in female endurance athletes. Specifically, the effect of a chocolate milk beverage will be examined versus a non-nutritive, flavor-matched placebo. The investigators hypothesize that the nighttime consumption of chocolate milk, a whole food complex, will result in improved next morning running performance versus placebo. Secondarily, the investigators hypothesize that any potential positive performance outcomes from the chocolate milk treatment may be due to an enhanced pre-exercise hydration status or improved exercise metabolism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

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

First Submitted

Initial submission to the registry

April 1, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 11, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
2 years until next milestone

Results Posted

Study results publicly available

March 13, 2017

Completed
Last Updated

March 13, 2017

Status Verified

January 1, 2017

Enrollment Period

10 months

First QC Date

April 1, 2014

Results QC Date

August 31, 2015

Last Update Submit

January 23, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Running Performance

    10K time trial on a treadmill

    24 hours

Secondary Outcomes (2)

  • Urine Specific Gravity

    24 hours

  • Urine Volume

    24 hour

Other Outcomes (1)

  • Exercise Metabolism

    24 hours

Study Arms (2)

chocolate milk

EXPERIMENTAL

In this arm, subjects receive chocolate milk

Other: chocolate milk

flavor-matched placebo

PLACEBO COMPARATOR

In this arm, subjects receive a flavor-matched placebo

Other: flavor-matched placebo

Interventions

12 oz, 7-8 hours prior to exercise trial (night before)

chocolate milk

12 oz, non-caloric flavor-matched placebo

flavor-matched placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • Between the ages of 18 and 40 years old
  • Consistently use oral contraceptives (greater than 2 months) or be considered eumenorrheic without oral contraceptive use
  • 'Moderately trained,' defined as a weekly mileage ≥ 25 miles for at least 6 months, and a VO2max ≥ 45 ml/kg/min

You may not qualify if:

  • Lactose intolerant
  • Smokers
  • Uncontrolled thyroid conditions
  • Uses anti-inflammatory drugs or any dietary supplements intended to improve performance
  • Have musculoskeletal injury that could limit performance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

Results Point of Contact

Title
Dr. Michael J. Ormsbee
Organization
Florida State University

Study Officials

  • Michael J Ormsbee, PhD

    Florida State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 1, 2014

First Posted

June 11, 2014

Study Start

June 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

March 13, 2017

Results First Posted

March 13, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations