Comparison of Time-Restricted Feeding Versus Grazing (TIMED EATING)
15. mars 2018 oppdatert av: Courtney Peterson, Pennington Biomedical Research Center
Time-Restricted Feeding to Improve Glucose Tolerance and Vascular Condition
The purpose of this pilot study is to find out what eating meals in a short time period early in the day (time-restricted feeding) versus eating meals spread out during the day (grazing) does to the body's ability to control blood sugar and to the health of its blood vessels.
The investigators hypothesize that time-restricted feeding will be more effective at improving glucose tolerance and vascular condition (inflammation and micro- and macro-vascular function) than grazing.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
Each participant will eat according to one of the two eating schedules (grazing or time-restricted feeding) for 5 weeks, have a 7-week washout period, and then eat according to the other eating schedule for 5 weeks.
Measurements of glucose homeostasis and vascular condition will be performed before and after a participant follows each eating schedule.
Studietype
Intervensjonell
Registrering (Faktiske)
8
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Louisiana
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Baton Rouge, Louisiana, Forente stater, 70808
- Pennington Biomedical Research Center
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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
35 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
- Are male
- Overweight: Have a body mass index between 25 and 50 kg/m^2 inclusive (a number calculated from height and weight)
- Are 35-70 years of age
- Have a hemoglobin A1C between 5.5 - 6.4% or prior medical indication of prediabetes
- Have a blood sugar level between 140 and 199 mg/dL two hours after drinking a sugary solution (OGTT)
- Have been eating dinner at least 8.5 hours after eating breakfast at least 90% of the time during the past year
- Have not fasted (go for a day without any food) more than 12 days total during the past year
- Be willing to eat most meals at Pennington Biomedical and/or under supervision
- Not eat any food other than that served by Pennington Biomedical
- Not drink any alcohol, juice, or other beverages that have calories other than what is served by Pennington Biomedical
- Keep water and no-calorie drinks like tea or diet soda the same during both of the timed eating periods
- Be willing to eat your meals according to the fixed schedules
Exclusion Criteria:
- Have diabetes or are on anti-diabetes medication
- Have evidence of cardiovascular disease
- Suffer from significant cardiovascular, renal (kidney), cardiac (heart), liver, lung or nervous system disease
- Evidence of significant gastrointestinal issues or surgery that impacts nutrient absorption
- Regularly use medications such as steroids, beta blockers, and adrenergic-stimulating agents
- Are on any regular medicine that has not had the same dose for 1 month or longer
- Have a clinically significant abnormality as measured by a blood test
- Regularly drink alcohol (more than 2 servings per day)
- Have to do any kind of heavy physical activity
- Currently perform overnight shift work more than one day a week
- Are not able to eat only the food served to you by Pennington Biomedical, while in the study
- Are not able to stop drinking alcohol or other drinks with calories (e.g., soda, juice) other than what is served to you by Pennington Biomedical, while in the study
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Time-Restricted Feeding (early in the day eating)
Participants will consume all meals early in the day and within a 6-hour window.
|
Time-restricted feeding is a variant of intermittent fasting that involves eating all of one's calories within a few hours each day (typically 4-9 hours), followed by a daily fast of 15-20 hours.
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Placebo komparator: Grazing
Participants will eat meals spread out over the course of the day.
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Grazing involves eating meals spread out over the course of the day.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Glucose Tolerance
Tidsramme: Before and after 5 weeks on each feeding schedule
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Glucose tolerance and indices of glucose homeostasis will be determined using an Oral Glucose Tolerance Test (OGTT).
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Before and after 5 weeks on each feeding schedule
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Vascular Function
Tidsramme: Before and after 5 weeks on each feeding schedule
|
Macro- and micro-vascular function will be assessed by Radial Artery Applanation Tonometry and by Orthogonal Polarization Spectroscopy.
The endpoints measured by these two tests include aortic blood pressure, arterial stiffness, capillary density, and red blood cell velocity.
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Before and after 5 weeks on each feeding schedule
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Change in Inflammation and Metabolic Markers
Tidsramme: Before and after 5 weeks on each feeding schedule
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Serum markers of inflammation, such as C-Reactive Protein (CRP) and inflammatory cytokines, and of metabolic processes will be measured (composite measure).
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Before and after 5 weeks on each feeding schedule
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
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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. juli 2013
Primær fullføring (Faktiske)
1. november 2017
Studiet fullført (Faktiske)
1. november 2017
Datoer for studieregistrering
Først innsendt
3. juli 2013
Først innsendt som oppfylte QC-kriteriene
9. juli 2013
Først lagt ut (Anslag)
10. juli 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. mars 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. mars 2018
Sist bekreftet
1. mars 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PBRC 13017
Legemiddel- og utstyrsinformasjon, studiedokumenter
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