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

18 avril 2017 mis à jour par: Intermountain Health Care, Inc.
The purpose of this study is to evaluate the effect of fasting on physical changes associated with cardiovascular disease.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

30

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Utah
      • Murray, Utah, États-Unis, 84107-5701
        • Intermountain Medical Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 70 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Autre: Fasting Day First
28±4 hours of water-only fasting followed by 28±4 hours fed
Comportemental: Fasting First
28±4 hours of water-only fasting followed by 28±4 hours fed
Autre: Fed Day First
28± 4 hours fed followed by 28± 4 hours of fasting
Comportemental: Fed First
28± 4 hours fed followed by 28± 4 hours of fasting

Que mesure l'étude ?

Principaux critères de jugement

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Intermountain Health Care, Inc.

Les enquêteurs

  • Chercheur principal: Benjamin D Horne, PhD, Intermountain Medical Center

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2010

Achèvement primaire (Réel)

1 août 2010

Achèvement de l'étude (Réel)

1 octobre 2010

Dates d'inscription aux études

Première soumission

28 janvier 2010

Première soumission répondant aux critères de contrôle qualité

29 janvier 2010

Première publication (Estimation)

1 février 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 juillet 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 avril 2017

Dernière vérification

1 mars 2011

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 154-002

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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