- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02160873
Nighttime Feeding and Morning Endurance Performance
Effect of Nighttime Feeding on Morning Performance in Female Endurance Athletes
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Florida
-
Tallahassee, Florida, Forente stater, 32306
- Florida State University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: chocolate milk
In this arm, subjects receive chocolate milk
|
12 oz, 7-8 hours prior to exercise trial (night before)
|
|
Placebo komparator: flavor-matched placebo
In this arm, subjects receive a flavor-matched placebo
|
12 oz, non-caloric flavor-matched placebo
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Running Performance
Tidsramme: 24 hours
|
10K time trial on a treadmill
|
24 hours
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Urine Specific Gravity
Tidsramme: 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
Tidsramme: 24 hour
|
Measurement of total urine output.
|
24 hour
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Exercise Metabolism
Tidsramme: 24 hours
|
Indirect calorimetry will be used to assess macronutrient use during exercise via the respiratory exchange ratio
|
24 hours
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Michael J Ormsbee, PhD, Florida State University
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- CHMK-1415
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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