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

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

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

30

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Utah
      • Murray, Utah, Förenta staterna, 84107-5701
        • Intermountain Medical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 70 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: Fasting Day First
28±4 hours of water-only fasting followed by 28±4 hours fed
Beteende: Fasting First
28±4 hours of water-only fasting followed by 28±4 hours fed
Övrig: Fed Day First
28± 4 hours fed followed by 28± 4 hours of fasting
Beteende: Fed First
28± 4 hours fed followed by 28± 4 hours of fasting

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline in Participant Glucose When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Human Growth Hormone (HGH) When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Insulin When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) When Fasting and Fed
Tidsram: 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
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Adiponectin When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Fibroblast Growth Factor-21 (FGF-21) When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant White Blood Cell Count (WBC) When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Hemoglobin When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Red Blood Cell Count (RBC) When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Hematocrit When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Platelet Count When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Mean Corpuscular Volume (MCV) When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Mean Corpuscular Hemoglobin (MCH) When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Mean Corpuscular Hemoglobin Concentration (MCHC) When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Red Cell Distribution Width (RDW) When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Mean Platelet Volume (MPV) When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Bicarbonate When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Sodium When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Chloride When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Blood Urea Nitrogen (BUN) When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Calcium When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Potassium When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Creatinine When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Total Cholesterol (TC) When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Low-Density Lipoprotein Cholesterol (LDL-C) When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant High-Density Lipoprotein Cholesterol (HDL-C) When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Triglycerides When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant TC/HDL Ratio When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Weight When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Waist Circumference When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Systolic Blood Pressure (SBP), Supine When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant Diastolic Blood Pressure (DBP), Supine When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days
Change From Baseline in Participant High Sensitivity C-Reactive Protein (hsCRP) When Fasting and Fed
Tidsram: Baseline and 3 days
Baseline and 3 days

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Intermountain Health Care, Inc.

Utredare

  • Huvudutredare: Benjamin D Horne, PhD, Intermountain Medical Center

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2010

Primärt slutförande (Faktisk)

1 augusti 2010

Avslutad studie (Faktisk)

1 oktober 2010

Studieregistreringsdatum

Först inskickad

28 januari 2010

Först inskickad som uppfyllde QC-kriterierna

29 januari 2010

Första postat (Uppskatta)

1 februari 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 juli 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 april 2017

Senast verifierad

1 mars 2011

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 154-002

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