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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02160873
Other study ID # CHMK-1415
Secondary ID
Status Completed
Phase N/A
First received April 1, 2014
Last updated May 25, 2015
Start date June 2014
Est. completion date April 2015

Study information

Verified date May 2015
Source Florida State University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

This study will be interventional in nature and employ a crossover, randomized, double-blinded approach. This study will include a maximal oxygen uptake test and three trials: one familiarization trial, and two experimental trials. The familiarization will serve as a practice test to minimize any training effects between experimental trials. The experimental trials will be completed within a 2-week period determined by the luteal phase of the menstrual cycle (days 15-28 of the menstrual cycle, with day 1 being the first day of menstruation). A minimum of 48-72 hours will be provided between testing days.

Experimental trials will consist of baseline testing (height, weight, urinalysis, resting metabolic rate), followed by a treadmill performance protocol. Participants will complete a 3-stage incremental exercise test (at 55%, 65%, and 75% of maximal oxygen uptake respectively). Metabolic data will be collected during this time. Participants will then complete a 10-kilometer running time trial in which markers of intensity are monitored at various time points (blood glucose, blood lactate, heart rate, rating of perceived exertion). Participants and primary researchers will be blinded to all time and speed data. Distance will be the only known measure of progress. Additional blood, urine, and body weight measures will be taken immediately post exercise.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- Female

- Between the ages of 18 and 35 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 = 40 ml/kg/min

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)


Related Conditions & MeSH terms


Intervention

Other:
chocolate milk
12 oz, 7-8 hours prior to exercise trial (night before)
flavor-matched placebo


Locations

Country Name City State
United States Florida State University Tallahassee Florida

Sponsors (2)

Lead Sponsor Collaborator
Florida State University Dymatize Nutrition to provide dietary supplements

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other exercise metabolism Indirect calorimetry will be used to assess macronutrient use during exercise 24 hours No
Primary running performance 10K time trial on a treadmill 24 hours No
Secondary hydration Urine specific gravity will be measured and urine volume will be measured pre and post a 10K time trial run on a treadmill 24 hours No
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