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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chocolate milk | Experimental | In this arm, subjects receive chocolate milk |
|
| flavor-matched placebo | Placebo Comparator | In this arm, subjects receive a flavor-matched placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chocolate milk | Other | 12 oz, 7-8 hours prior to exercise trial (night before) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Running Performance | 10K time trial on a treadmill | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Urine Specific Gravity | Changes in urine specific gravity will be measured pre and post a 10K time trial run on a treadmill | 24 hours |
| Urine Volume | Measurement of total urine output. |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise Metabolism | Indirect calorimetry will be used to assess macronutrient use during exercise via the respiratory exchange ratio | 24 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Ormsbee, PhD | Florida State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida State University | Tallahassee | Florida | 32306 | United States |
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Subjects were randomized to receive either chocolate milk first or placebo first. In between exercise trials, there was a 7-day washout period.
12 subjects were recruited from the Tallahassee running community.
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| ID | Title | Description |
|---|---|---|
| FG000 | Chocolate Milk, Then Placebo | Subjects received chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before). Thereafter, there was a 7 day washout period. Then, subjects received the placebo beverage 7-8 hours prior to the exercise trial. |
| FG001 | Flavor-matched Placebo, Then Chocolate Milk. | Subjects received flavor-matched placebo: 12 oz, 7-8 hours prior to exercise trial (night before). Thereafter, there was a 7 day washout period. Then, subjects received 12 oz of chocolate milk 7-8 hours prior to exercise. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Trained runners and triathletes
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| ID | Title | Description |
|---|---|---|
| BG000 | Chocolate Milk First, Then Placebo | chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before) followed by a 7-day washout, then placebo 7-8 hours prior to exercise trial. |
| BG001 | Flavor-matched Placebo, Then Chocolate Milk |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Running Performance | 10K time trial on a treadmill | Posted | Mean | Standard Deviation | minutes | 24 hours |
|
|
Data was collected for 4 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chocolate Milk | chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Reduced sleep quality | General disorders | Non-systematic Assessment | Subjects reported altered sleep quality and/or duration following intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael J. Ormsbee | Florida State University | (850) 645-5000 | mormsbee@fsu.edu |
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| flavor-matched placebo |
| Other |
12 oz, non-caloric flavor-matched placebo |
|
| 24 hour |
flavor-matched placebo: 12 oz, 7-8 hours prior to exercise trial (night before) followed by a 7-day washout, then chocolate milk 7-8 hours prior to exercise trial. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body fat (%) | Mean | Standard Deviation | % |
|
| Maximal oxygen consumption (ml/kg/min) | Mean | Standard Deviation | ml/kg/min |
|
|
|
| Secondary | Urine Specific Gravity | Changes in urine specific gravity will be measured pre and post a 10K time trial run on a treadmill | Posted | Mean | Standard Deviation | Urine specific gravity | 24 hours |
|
|
|
| Other Pre-specified | Exercise Metabolism | Indirect calorimetry will be used to assess macronutrient use during exercise via the respiratory exchange ratio | Posted | Mean | Standard Deviation | Respiratory exchange ratio | 24 hours |
|
|
|
| Secondary | Urine Volume | Measurement of total urine output. | Posted | Mean | Standard Deviation | mililiters | 24 hour |
|
|
|
| 0 |
| 12 |
| 4 |
| 12 |
| EG001 | Flavor-matched Placebo | flavor-matched placebo: 12 oz, 7-8 hours prior to exercise trial (night before) | 0 | 12 | 0 | 12 |
|
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| 75% VO2max |
|