This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT01059760
First received: January 28, 2010
Last updated: April 18, 2017
Last verified: March 2011
  Purpose
The purpose of this study is to evaluate the effect of fasting on physical changes associated with cardiovascular disease.

Condition Intervention
Cardiovascular Disease Behavioral: Fasting First Behavioral: Fed First

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Expression of Longevity Genes in Response to Extended Fasting

Resource links provided by NLM:


Further study details as provided by Intermountain Health Care, Inc.:

Primary Outcome Measures:
  • Change From Baseline in Participant Glucose When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant Human Growth Hormone (HGH) When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant Insulin When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) When Fasting and Fed [ Time Frame: 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

  • Change From Baseline in Participant Glycogen-Like Protein-1 (GLP-1) When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant Adiponectin When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant Fibroblast Growth Factor-21 (FGF-21) When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant White Blood Cell Count (WBC) When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant Hemoglobin When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant Red Blood Cell Count (RBC) When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant Hematocrit When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant Platelet Count When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant Mean Corpuscular Volume (MCV) When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant Mean Corpuscular Hemoglobin (MCH) When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant Mean Corpuscular Hemoglobin Concentration (MCHC) When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant Red Cell Distribution Width (RDW) When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant Mean Platelet Volume (MPV) When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant Bicarbonate When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant Sodium When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant Chloride When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant Blood Urea Nitrogen (BUN) When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant Calcium When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant Potassium When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant Creatinine When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant Total Cholesterol (TC) When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant Low-Density Lipoprotein Cholesterol (LDL-C) When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant High-Density Lipoprotein Cholesterol (HDL-C) When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant Triglycerides When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant TC/HDL Ratio When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant Weight When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant Waist Circumference When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant Systolic Blood Pressure (SBP), Supine When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant Diastolic Blood Pressure (DBP), Supine When Fasting and Fed [ Time Frame: Baseline and 3 days ]
  • Change From Baseline in Participant High Sensitivity C-Reactive Protein (hsCRP) When Fasting and Fed [ Time Frame: Baseline and 3 days ]

Enrollment: 30
Study Start Date: January 2010
Study Completion Date: October 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Fasting Day First
28±4 hours of water-only fasting followed by 28±4 hours fed
Behavioral: Fasting First
28±4 hours of water-only fasting followed by 28±4 hours fed
Fed Day First
28± 4 hours fed followed by 28± 4 hours of fasting
Behavioral: Fed First
28± 4 hours fed followed by 28± 4 hours of fasting

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01059760

Locations
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84107-5701
Sponsors and Collaborators
Intermountain Health Care, Inc.
Investigators
Principal Investigator: Benjamin D Horne, PhD Intermountain Medical Center
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT01059760     History of Changes
Other Study ID Numbers: 154-002
Study First Received: January 28, 2010
Results First Received: December 21, 2016
Last Updated: April 18, 2017

Keywords provided by Intermountain Health Care, Inc.:
Fasting
Short-term starvation
Diet
Coronary artery disease

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 21, 2017