- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02160873
Nighttime Feeding and Morning Endurance Performance
Effect of Nighttime Feeding on Morning Performance in Female Endurance Athletes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Tallahassee, Florida, United States, 32306
- Florida State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: chocolate milk
In this arm, subjects receive chocolate milk
|
12 oz, 7-8 hours prior to exercise trial (night before)
|
Placebo Comparator: flavor-matched placebo
In this arm, subjects receive a flavor-matched placebo
|
12 oz, non-caloric flavor-matched placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Running Performance
Time Frame: 24 hours
|
10K time trial on a treadmill
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
24 hours
|
Urine Volume
Time Frame: 24 hour
|
Measurement of total urine output.
|
24 hour
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exercise Metabolism
Time Frame: 24 hours
|
Indirect calorimetry will be used to assess macronutrient use during exercise via the respiratory exchange ratio
|
24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael J Ormsbee, PhD, Florida State University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CHMK-1415
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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