Trial Outcomes & Findings for Nighttime Feeding and Morning Endurance Performance (NCT NCT02160873)

NCT ID: NCT02160873

Last Updated: 2017-03-13

Results Overview

10K time trial on a treadmill

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2017-03-13

Participant Flow

12 subjects were recruited from the Tallahassee running community.

Subjects were randomized to receive either chocolate milk first or placebo first. In between exercise trials, there was a 7-day washout period.

Participant milestones

Measure	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.	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.
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nighttime Feeding and Morning Endurance Performance

Baseline characteristics by cohort

Measure	Chocolate Milk First, Then Placebo n=6 Participants 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.	Flavor-matched Placebo, Then Chocolate Milk n=6 Participants 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.	Total n=12 Participants Total of all reporting groups
Age, Continuous	30.3 years STANDARD_DEVIATION 6.4 • n=5 Participants	29.3 years STANDARD_DEVIATION 7.1 • n=7 Participants	29.8 years STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
Body fat (%)	21.4 % STANDARD_DEVIATION 5.7 • n=5 Participants	22.1 % STANDARD_DEVIATION 5.0 • n=7 Participants	21.8 % STANDARD_DEVIATION 5.1 • n=5 Participants
Maximal oxygen consumption (ml/kg/min)	51.8 ml/kg/min STANDARD_DEVIATION 4.1 • n=5 Participants	53.8 ml/kg/min STANDARD_DEVIATION 4.5 • n=7 Participants	52.8 ml/kg/min STANDARD_DEVIATION 4.2 • n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

10K time trial on a treadmill

Outcome measures

Measure	Chocolate Milk n=12 Participants chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before)	Flavor-matched Placebo n=12 Participants flavor-matched placebo: 12 oz, 7-8 hours prior to exercise trial (night before)
Running Performance	52.8 minutes Standard Deviation 8.0	52.8 minutes Standard Deviation 8.4

SECONDARY outcome

Timeframe: 24 hours

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

Outcome measures

Measure	Chocolate Milk n=12 Participants chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before)	Flavor-matched Placebo n=12 Participants flavor-matched placebo: 12 oz, 7-8 hours prior to exercise trial (night before)
Urine Specific Gravity	-0.005 Urine specific gravity Standard Deviation 0.008	-0.002 Urine specific gravity Standard Deviation 0.009

SECONDARY outcome

Timeframe: 24 hour

Measurement of total urine output.

Outcome measures

Measure	Chocolate Milk n=12 Participants chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before)	Flavor-matched Placebo n=12 Participants flavor-matched placebo: 12 oz, 7-8 hours prior to exercise trial (night before)
Urine Volume	718.07 mililiters Standard Deviation 260.82	874.82 mililiters Standard Deviation 179.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours

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

Outcome measures

Measure	Chocolate Milk n=12 Participants chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before)	Flavor-matched Placebo n=12 Participants flavor-matched placebo: 12 oz, 7-8 hours prior to exercise trial (night before)
Exercise Metabolism 55% VO2max	0.84 Respiratory exchange ratio Standard Deviation 0.04	0.82 Respiratory exchange ratio Standard Deviation 0.04
Exercise Metabolism 65% VO2max	0.85 Respiratory exchange ratio Standard Deviation 0.04	0.83 Respiratory exchange ratio Standard Deviation 0.03
Exercise Metabolism 75% VO2max	0.87 Respiratory exchange ratio Standard Deviation 0.03	0.85 Respiratory exchange ratio Standard Deviation 0.03

Adverse Events

Chocolate Milk

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Flavor-matched Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Chocolate Milk n=12 participants at risk chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before)	Flavor-matched Placebo n=12 participants at risk flavor-matched placebo: 12 oz, 7-8 hours prior to exercise trial (night before)
General disorders Reduced sleep quality	33.3% 4/12 • Number of events 4 • Data was collected for 4 weeks.	0.00% 0/12 • Data was collected for 4 weeks.

Additional Information

Dr. Michael J. Ormsbee

Florida State University

Phone: (850) 645-5000

Email: mormsbee@fsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place