Comparison of Time-Restricted Feeding Versus Grazing (TIMED EATING)
15. marts 2018 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
8
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70808
- Pennington Biomedical Research Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
35 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Glucose Tolerance
Tidsramme: Before and after 5 weeks on each feeding schedule
|
Glucose tolerance and indices of glucose homeostasis will be determined using an Oral Glucose Tolerance Test (OGTT).
|
Before and after 5 weeks on each feeding schedule
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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.
|
Before and after 5 weeks on each feeding schedule
|
|
Change in Inflammation and Metabolic Markers
Tidsramme: Before and after 5 weeks on each feeding schedule
|
Serum markers of inflammation, such as C-Reactive Protein (CRP) and inflammatory cytokines, and of metabolic processes will be measured (composite measure).
|
Before and after 5 weeks on each feeding schedule
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2013
Primær færdiggørelse (Faktiske)
1. november 2017
Studieafslutning (Faktiske)
1. november 2017
Datoer for studieregistrering
Først indsendt
3. juli 2013
Først indsendt, der opfyldte QC-kriterier
9. juli 2013
Først opslået (Skøn)
10. juli 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. marts 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. marts 2018
Sidst verificeret
1. marts 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PBRC 13017
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
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