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OpenTrials
Completed

NCT Number: NCT02160873

Nighttime Feeding and Morning Endurance Performance

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University

Tallahassee, Florida, 32306, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

Chocolate Milk

Other

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

flavor-matched placebo

Other

12 oz, non-caloric flavor-matched placebo

Primary outcomes

  1. Running Performance

    Time frame: 24 hours

    10K time trial on a treadmill

Secondary outcomes

  1. Urine Specific Gravity

    Time frame: 24 hours

    Changes in urine specific gravity will be measured pre and post a 10K time trial run on a treadmill

  2. Urine Volume

    Time frame: 24 hour

    Measurement of total urine output.

Other outcomes

  1. Exercise Metabolism

    Time frame: 24 hours

    Indirect calorimetry will be used to assess macronutrient use during exercise via the respiratory exchange ratio

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Official study title

Effect of Nighttime Feeding on Morning Performance in Female Endurance Athletes

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 11, 2014
Registry last updated
Mar 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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