Poor Performance StatusNCT02160873
Nighttime Feeding and Morning Endurance Performance
A study testing chocolate milk in people with Poor Performance Status, run by Florida State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Poor Performance Status
- What is being tested?
- chocolate milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Apr 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32306
About this study
Official title: Effect of Nighttime Feeding on Morning Performance in Female Endurance Athletes
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.
Read the 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.
- Conditions
- Poor Performance Status
- Being tested
- chocolate milk, flavor-matched placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chocolate milkOther
12 oz, 7-8 hours prior to exercise trial (night before)
flavor-matched placeboOther
12 oz, non-caloric flavor-matched placebo
| Study group | Role | What they receive |
|---|---|---|
| chocolate milk | Experimental | In this arm, subjects receive chocolate milk Receives: Other: chocolate milk |
| flavor-matched placebo | Placebo comparator | In this arm, subjects receive a flavor-matched placebo Receives: Other: flavor-matched placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Running Performance
10K time trial on a treadmill
Measured: 24 hours
Secondary outcomes (2)
Urine Specific Gravity
Changes in urine specific gravity will be measured pre and post a 10K time trial run on a treadmill
Measured: 24 hours
Urine Volume
Measurement of total urine output.
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Poor Performance StatusStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J. Ormsbee, Florida State University
- Investigators
- Michael J Ormsbee, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160873
- Sponsor's protocol ID
- CHMK-1415
- Status last verified
- Jan 2017
- First submitted
- 1 Apr 2014
- Last updated
- 13 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nighttime Feeding on Morning Performance in Female Endurance Athletes
- ClinicalTrials.gov ID
- NCT02160873
- Acronym / sponsor ID
- CHMK-1415
- Conditions
- Poor Performance Status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 11 Jun 2014 (estimated)
- Results
- Posted 13 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chocolate milk | Experimental | Other: chocolate milkIn this arm, subjects receive chocolate milk |
| flavor-matched placebo | Placebo comparator | Other: flavor-matched placeboIn this arm, subjects receive a flavor-matched placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chocolate milk12 oz, 7-8 hours prior to exercise trial (night before) | Other | chocolate milk |
| flavor-matched placebo12 oz, non-caloric flavor-matched placebo | Other | flavor-matched placebo |
Primary outcome
Running Performance
Time frame: 24 hours
10K time trial on a treadmill
2 secondary outcomes
Urine Specific Gravity
Time frame: 24 hours
Urine Volume
Time frame: 24 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Poor Performance Status
RecruitingPhase 2
Study to Confirm Efficacy and Feasibility of Tarlatamab Treatment in Patients With Extensive Stage Small-cell Lung Cancer With Poor Performance Status
Small-cell Lung Cancer
Active, not recruitingPhase 2
Adagrasib in Patients With KRASG12C-mutant NSCLC Who Are Elderly or Have Poor Performance Status
NSCLC Stage IV, KRAS P.G12C
Not yet recruitingPhase 2
Sequential Toripalimab and Paclitaxel in Patients With Head and Neck Squamous Cell Cancer (HNSCC) and Poor Performance Status
Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)
RecruitingPhase 2
Pembrolizumab for Advanced NSCLC and PS 2-3
Non-Small Cell Lung Cancer (NSCLC)
Not yet recruitingPhase 2
Adebrelimab Combined With Oral Etoposide for Elderly Patients and Patients With Poor Performance Status in Small Cell Lung Cancer: An Exploratory Clinical Study
Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Ormsbee, PhD principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chocolate milk in people with Poor Performance Status, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Running Performance (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2017.