Sleep Restriction and Energy Expenditure
1. august 2013 oppdatert av: St. Luke's-Roosevelt Hospital Center
The Effect of Sleep Reduction on Daily Energy Expenditure, Thermic Effect of Food, and Substrate Oxidation in Overweight Women
Each 4-day period will follow the same protocol.
Basically, for the entire study, we will prepare all of the subject's food and will require him or her to eat all of the food that we give at the times we tell them to eat.
The subject will arrive at the hospital on the evening of day 1, and become inpatients.
On day 2, the subject will be permitted to leave the hospital campus under the supervision of the research staff.
On day 3, they will be required to stay in a small room called a metabolic chamber for 24 hours.
This room measures how many calories you burn in one day.
On day 4, we will measure the subject's energy expenditure in response to a breakfast meal.
They will be given breakfast and the number of calories that they burn after that meal will be measured over a 6-hour period.
Then the subject will be discharged at the end of the test.
The 2 study periods will differ only in bedtimes and wakeup times.
During one period, the subject will go to bed at 1 am and wake up at 5 am and during the other period they will go to bed at 11 pm and wake up at 7 am.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Sleeping metabolic rate will be measured using a metabolic chamber on the night of day 2.
During day 3, 24-hour energy expenditure (including a second night of measurement) will be measured in the metabolic chamber.
On this day, the participant will perform 2 bouts of physical activity on a stationary bicycle for 15 minutes each bout.
This will give us a measurement of physical activity energy expenditure.
On day 4, at 7 am, the participant will exit the metabolic chamber and will enter a different, smaller metabolic chamber for the measurement of energy expenditure in response to a meal.
This measurement will start at approximately 8 am with assessment of the resting metabolic rate (45 minutes).
The participant will then be given a high-fat meal replacement to consume over 10 minutes.
Energy expenditure measurements continue in the metabolic chamber for a 6-hour period.
Studietype
Intervensjonell
Registrering (Forventet)
10
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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New York
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New York, New York, Forente stater, 10026
- St. Luke's Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
21 år til 45 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- Age 21-45 yrs
- Non-pregnant, non-lactating female subjects
- Body mass index (BMI) 25-28 kg/m2
- Weight stable (± 2.5 kg) for at least 3 mo prior to evaluation
- If a woman of child-bearing potential, must be willing to adhere to an acceptable form of contraception
- Non-smoker
- Regularly sleeps 7-8.5 hours/night
- If taking any form of medication, other than those listed in the exclusion criteria, must have been stable and remain on the same medication and medication dose throughout the study
Exclusion Criteria:
- Diabetes, uncontrolled hypertension
- Attempted to lose weight in past 3 months
- Eating disorder
- Stroke, seizure disorder, or other significant neurological disease;
- HIV positive by self-report
- Unstable or uncontrolled medical illness including active malignancies within past 5 yrs
- Untreated or unstable hypothyroidism
- Hyperthyroidism
- A score on the Brief Psychiatric Inventory that exceeds the 90th percentile;
- Subjects with psychoses, bipolar disorder, major depression, severe personality disorders, suicidal
- Alcohol or substance abuse in the past 6 mo
- Pregnant, planning pregnancy in the next 6 mo, or breast-feeding
- Participating in a commercial diet or behavior modification program (e.g., Weight Watchers), or plans to participate
- Shift worker, commercial long-distance driver, heavy equipment operator, history of drowsy driving
- Takes naps regularly
- Has traveled across time zones in the past 4 weeks or plans to during the weeks of the study
- Excessive caffeine intake
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Habitual Sleep
Women sleep 8 h/night throughout the study phase
|
Participants sleep 8 h/night throughout the study phase (from 11 pm to 7 am)
|
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Eksperimentell: Short Sleep
Women sleep 4 h/night throughout the study phase
|
Participants will be restricted in sleep and only allowed to sleep from 1 am to 5 am.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Resting Metabolic Rate
Tidsramme: 32 hours
|
Metabolic rate from 11 pm on day 2 until 7 am on the morning of day 4 will be measured in a metabolic chamber.
The metabolic chamber is an air-tight room (22,000 l volume) equipped with a bed, chair, desk, television, VCR, telephone, treadmill, sink and toilet.
All meals and snacks will be served at the scheduled time.
Subjects will be asked to perform 30 min of light physical activity at 1500 h and 2030 h.
Physical activity will consist of 30 min of cycling at 12 mi/h.
Bedtimes will be the same as the previous night and actigraph monitoring will be used to confirm compliance with the sleep protocol.
Women will exit the chamber at 0700 h the following day.
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32 hours
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Post Prandial Energy Expenditure and Thermic Effect of Food
Tidsramme: 8 hours on day 4
|
Energy expenditure will be measured from 8 am until approximately 2:30 pm on day. Resting metabolic rate over 45 minutes will be measured at 8 am, followed by breakfast and resumption of energy expenditure measurements postprandially. Participants will be given 15 min to consume a high-fat breakfast (50% of energy from fat) and post-prandial thermogenesis and substrate oxidation will be measured for the next 6 h. |
8 hours on day 4
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Marie-Pierre St. Onge, PhD, St. Luke's Roosevelt Hospital/Columbia University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2011
Primær fullføring (Faktiske)
1. desember 2012
Studiet fullført (Faktiske)
1. april 2013
Datoer for studieregistrering
Først innsendt
6. juni 2012
Først innsendt som oppfylte QC-kriteriene
13. desember 2012
Først lagt ut (Anslag)
18. desember 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
2. august 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. august 2013
Sist bekreftet
1. desember 2011
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
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