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Expression of Longevity Genes in Response to Extended Fasting (FEELGOOD)

18. april 2017 opdateret af: Intermountain Health Care, Inc.
The purpose of this study is to evaluate the effect of fasting on physical changes associated with cardiovascular disease.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Coronary heart disease (CHD) is the largest contributor to morbidity and mortality in the Western world and is associated with high-calorie diet, high body mass, and a variety of other factors. CHD can lead to myocardial infarction (MI) and other embolic events. A growing body of evidence suggests that relatively low caloric intake in the diets of a variety of animals increases longevity and preliminary evidence among humans indicates that such caloric restriction reduces risk factors for CHD, including cholesterol levels, blood pressure, glucose, and obesity. Caloric restriction has also been shown to alter the expression of certain genes, especially the forkhead box (FOX) O and sirtuin (SIRT) genes whose over-expression has been shown to increase longevity in animal models. Extended avoidance of caloric intake, also called fasting or short-term starvation, has been shown to increase expression of the FOXA genes that have similar sequence and function as the FOXO genes and that have been shown to increase longevity among animals regardless of FOXO function. We recently demonstrated that the risk of CHD was significantly lower among patients who reported a history of routine periodic extended fasting. The two primary hypotheses for this observation are that fasting may improve individual ability to control dietary intake or that fasting may initiate a cascade of protective mechanisms that preserve cellular and metabolic health.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Utah
      • Murray, Utah, Forenede Stater, 84107-5701
        • Intermountain Medical 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

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. The volunteer (male or non-pregnant female, any ethnicity) must be >18 years of age.
  2. The volunteer must either have a body mass index of 25.0-35.0 kg/m2 or the combination of a body mass index of 18.5-24.9 kg/m2 and two or more previously or currently measured symptoms of the metabolic syndrome (fasting glucose≥110 mg/dL, triglycerides≥150 mg/dL, high-density lipoprotein cholesterol<40 mg/dL in males or <50 mg/dL in females, systolic blood pressure≥130 mmHg or diastolic blood pressure≥85 mmHg, or waist circumference≥40 inches in males or ≥36 inches in females [glucose and cholesterol levels may be self-reported]).
  3. The volunteer has not routinely participated in caloric restriction (deliberate limitation of caloric intake of <80% than the FDA-recommended daily caloric intake) within the last 2 years, has not participated in extended fasting (>12 hours at a time) for at least a year, and does not deliberately skip meals as a routine dietary practice.

Exclusion Criteria:

  1. Body mass index <18.5 or >35 kg/m2.
  2. Current active cancer treatment, treatment with immunosuppressive medications, or solid organ transplantation within 1 year.
  3. Presence of immunosuppressive disease, myocardial infarction, peripheral vascular disease, or stroke within the past year.
  4. Use of insulin.
  5. Although it is unlikely fasting will harm the pregnant or lactating woman, the dietary restrictions placed on the participant for the duration of the study may conflict with dietary recommendations for pregnant or lactating women. Women of child bearing potential, therefore, will meet an exclusion if they become pregnant.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Fasting Day First
28±4 hours of water-only fasting followed by 28±4 hours fed
Adfærdsmæssigt: Fasting First
28±4 hours of water-only fasting followed by 28±4 hours fed
Andet: Fed Day First
28± 4 hours fed followed by 28± 4 hours of fasting
Adfærdsmæssigt: Fed First
28± 4 hours fed followed by 28± 4 hours of fasting

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Participant Glucose When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Human Growth Hormone (HGH) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Insulin When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) When Fasting and Fed
Tidsramme: Baseline and 3 days
HOMA-IR is used to measure the severity of insulin resistance. Healthy Range: 1.0 (0.5-1.4) Less than 1.0 is optimal Above 1.9 indicates early insulin resistance Above 2.9 indicates significant insulin resistance
Baseline and 3 days
Change From Baseline in Participant Glycogen-Like Protein-1 (GLP-1) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Adiponectin When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Fibroblast Growth Factor-21 (FGF-21) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant White Blood Cell Count (WBC) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Hemoglobin When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Red Blood Cell Count (RBC) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Hematocrit When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Platelet Count When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Mean Corpuscular Volume (MCV) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Mean Corpuscular Hemoglobin (MCH) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Mean Corpuscular Hemoglobin Concentration (MCHC) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Red Cell Distribution Width (RDW) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Mean Platelet Volume (MPV) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Bicarbonate When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Sodium When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Chloride When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Blood Urea Nitrogen (BUN) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Calcium When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Potassium When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Creatinine When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Total Cholesterol (TC) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Low-Density Lipoprotein Cholesterol (LDL-C) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant High-Density Lipoprotein Cholesterol (HDL-C) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Triglycerides When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant TC/HDL Ratio When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Weight When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Waist Circumference When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Systolic Blood Pressure (SBP), Supine When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Diastolic Blood Pressure (DBP), Supine When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant High Sensitivity C-Reactive Protein (hsCRP) When Fasting and Fed
Tidsramme: Baseline and 3 days
Baseline and 3 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Intermountain Health Care, Inc.

Efterforskere

  • Ledende efterforsker: Benjamin D Horne, PhD, Intermountain Medical Center

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.

Generelle publikationer

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. januar 2010

Primær færdiggørelse (Faktiske)

1. august 2010

Studieafslutning (Faktiske)

1. oktober 2010

Datoer for studieregistrering

Først indsendt

28. januar 2010

Først indsendt, der opfyldte QC-kriterier

29. januar 2010

Først opslået (Skøn)

1. februar 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juli 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. april 2017

Sidst verificeret

1. marts 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 154-002

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kardiovaskulær sygdom

Kliniske forsøg med Fasting First

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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