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The purpose of this study is to evaluate the effect of fasting on physical changes associated with cardiovascular disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasting Day First | Other | 28±4 hours of water-only fasting followed by 28±4 hours fed |
|
| Fed Day First | Other | 28± 4 hours fed followed by 28± 4 hours of fasting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasting First | Behavioral | 28±4 hours of water-only fasting followed by 28±4 hours fed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Participant Glucose When Fasting and Fed | Baseline and 3 days | |
| Change From Baseline in Participant Human Growth Hormone (HGH) When Fasting and Fed | Baseline and 3 days | |
| Change From Baseline in Participant Insulin When Fasting and Fed | Baseline and 3 days | |
| Change From Baseline in Participant Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) When Fasting and Fed | 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 | Baseline and 3 days | |
| Change From Baseline in Participant Adiponectin When Fasting and Fed | Baseline and 3 days | |
| Change From Baseline in Participant Fibroblast Growth Factor-21 (FGF-21) When Fasting and Fed | Baseline and 3 days | |
| Change From Baseline in Participant White Blood Cell Count (WBC) When Fasting and Fed | Baseline and 3 days | |
| Change From Baseline in Participant Hemoglobin When Fasting and Fed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin D Horne, PhD | Intermountain Health Care, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intermountain Medical Center | Murray | Utah | 84107-5701 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18805103 | Background | Horne BD, May HT, Anderson JL, Kfoury AG, Bailey BM, McClure BS, Renlund DG, Lappe DL, Carlquist JF, Fisher PW, Pearson RR, Bair TL, Adams TD, Muhlestein JB; Intermountain Heart Collaborative Study. Usefulness of routine periodic fasting to lower risk of coronary artery disease in patients undergoing coronary angiography. Am J Cardiol. 2008 Oct 1;102(7):814-819. doi: 10.1016/j.amjcard.2008.05.021. Epub 2008 Jul 10. | |
| 39991046 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fasting Day First | 28±4 hours of water-only fasting followed by 28±4 hours fed |
| FG001 | Fed Day First | 28± 4 hours fed followed by 28± 4 hours of fasting |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fasting Day First | 28±4 hours of water-only fasting followed by 28±4 hours fed |
| BG001 | Fed Day First | 28± 4 hours fed followed by 28± 4 hours of fasting |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Participant Glucose When Fasting and Fed | Posted | Mean | Standard Deviation | mg/dL | Baseline and 3 days |
|
|
3 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fasting Day First | Includes those who fasted on the 1st day. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild Headache | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin D. Horne | Intermountain Heart Institute | 8015074708 | benjamin.horne@imail.org |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D005215 | Fasting |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
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| Fed First | Behavioral | 28± 4 hours fed followed by 28± 4 hours of fasting |
|
| Baseline and 3 days |
| Change From Baseline in Participant Red Blood Cell Count (RBC) When Fasting and Fed | Baseline and 3 days |
| Change From Baseline in Participant Hematocrit When Fasting and Fed | Baseline and 3 days |
| Change From Baseline in Participant Platelet Count When Fasting and Fed | Baseline and 3 days |
| Change From Baseline in Participant Mean Corpuscular Volume (MCV) When Fasting and Fed | Baseline and 3 days |
| Change From Baseline in Participant Mean Corpuscular Hemoglobin (MCH) When Fasting and Fed | Baseline and 3 days |
| Change From Baseline in Participant Mean Corpuscular Hemoglobin Concentration (MCHC) When Fasting and Fed | Baseline and 3 days |
| Change From Baseline in Participant Red Cell Distribution Width (RDW) When Fasting and Fed | Baseline and 3 days |
| Change From Baseline in Participant Mean Platelet Volume (MPV) When Fasting and Fed | Baseline and 3 days |
| Change From Baseline in Participant Bicarbonate When Fasting and Fed | Baseline and 3 days |
| Change From Baseline in Participant Sodium When Fasting and Fed | Baseline and 3 days |
| Change From Baseline in Participant Chloride When Fasting and Fed | Baseline and 3 days |
| Change From Baseline in Participant Blood Urea Nitrogen (BUN) When Fasting and Fed | Baseline and 3 days |
| Change From Baseline in Participant Calcium When Fasting and Fed | Baseline and 3 days |
| Change From Baseline in Participant Potassium When Fasting and Fed | Baseline and 3 days |
| Change From Baseline in Participant Creatinine When Fasting and Fed | Baseline and 3 days |
| Change From Baseline in Participant Total Cholesterol (TC) When Fasting and Fed | Baseline and 3 days |
| Change From Baseline in Participant Low-Density Lipoprotein Cholesterol (LDL-C) When Fasting and Fed | Baseline and 3 days |
| Change From Baseline in Participant High-Density Lipoprotein Cholesterol (HDL-C) When Fasting and Fed | Baseline and 3 days |
| Change From Baseline in Participant Triglycerides When Fasting and Fed | Baseline and 3 days |
| Change From Baseline in Participant TC/HDL Ratio When Fasting and Fed | Baseline and 3 days |
| Change From Baseline in Participant Weight When Fasting and Fed | Baseline and 3 days |
| Change From Baseline in Participant Waist Circumference When Fasting and Fed | Baseline and 3 days |
| Change From Baseline in Participant Systolic Blood Pressure (SBP), Supine When Fasting and Fed | Baseline and 3 days |
| Change From Baseline in Participant Diastolic Blood Pressure (DBP), Supine When Fasting and Fed | Baseline and 3 days |
| Change From Baseline in Participant High Sensitivity C-Reactive Protein (hsCRP) When Fasting and Fed | Baseline and 3 days |
| Derived |
| Horne BD, Anderson JL, May HT, Bair TL, Le VT, Iverson L, Knowlton KU, Muhlestein JB. Weight loss-independent changes in human growth hormone during water-only fasting: a secondary evaluation of a randomized controlled trial. Front Endocrinol (Lausanne). 2025 Feb 7;15:1401780. doi: 10.3389/fendo.2024.1401780. eCollection 2024. |
| 33512717 | Derived | Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2. |
| 23220077 | Derived | Horne BD, Muhlestein JB, Lappe DL, May HT, Carlquist JF, Galenko O, Brunisholz KD, Anderson JL. Randomized cross-over trial of short-term water-only fasting: metabolic and cardiovascular consequences. Nutr Metab Cardiovasc Dis. 2013 Nov;23(11):1050-7. doi: 10.1016/j.numecd.2012.09.007. Epub 2012 Dec 7. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Hemoglobin A1C | Mean | Standard Deviation | percentage |
|
|
| Primary | Change From Baseline in Participant Human Growth Hormone (HGH) When Fasting and Fed | Posted | Mean | Standard Deviation | ng/mL | Baseline and 3 days |
|
|
|
| Primary | Change From Baseline in Participant Insulin When Fasting and Fed | Posted | Mean | Standard Deviation | mU/L | Baseline and 3 days |
|
|
|
| Primary | Change From Baseline in Participant Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) When Fasting and Fed | 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 | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3 days |
|
|
|
| Primary | Change From Baseline in Participant Glycogen-Like Protein-1 (GLP-1) When Fasting and Fed | Posted | Mean | Standard Deviation | ng/mL | Baseline and 3 days |
|
|
|
| Primary | Change From Baseline in Participant Adiponectin When Fasting and Fed | Posted | Mean | Standard Deviation | ratio of high molecular to total | Baseline and 3 days |
|
|
|
| Primary | Change From Baseline in Participant Fibroblast Growth Factor-21 (FGF-21) When Fasting and Fed | Posted | Mean | Standard Deviation | pg/mL | Baseline and 3 days |
|
|
|
| Primary | Change From Baseline in Participant White Blood Cell Count (WBC) When Fasting and Fed | Posted | Mean | Standard Deviation | cells/mL | Baseline and 3 days |
|
|
|
| Primary | Change From Baseline in Participant Hemoglobin When Fasting and Fed | Posted | Mean | Standard Deviation | g/dL | Baseline and 3 days |
|
|
|
| Primary | Change From Baseline in Participant Red Blood Cell Count (RBC) When Fasting and Fed | Posted | Mean | Standard Deviation | cells x 10^6/mL | Baseline and 3 days |
|
|
|
| Primary | Change From Baseline in Participant Hematocrit When Fasting and Fed | Posted | Mean | Standard Deviation | % of red blood cells to whole blood | Baseline and 3 days |
|
|
|
| Primary | Change From Baseline in Participant Platelet Count When Fasting and Fed | Posted | Mean | Standard Deviation | cells x 10^3/mL | Baseline and 3 days |
|
|
|
| Primary | Change From Baseline in Participant Mean Corpuscular Volume (MCV) When Fasting and Fed | Posted | Mean | Standard Deviation | fL | Baseline and 3 days |
|
|
|
| Primary | Change From Baseline in Participant Mean Corpuscular Hemoglobin (MCH) When Fasting and Fed | Posted | Mean | Standard Deviation | pg | Baseline and 3 days |
|
|
|
| Primary | Change From Baseline in Participant Mean Corpuscular Hemoglobin Concentration (MCHC) When Fasting and Fed | Posted | Mean | Standard Deviation | g/dL | Baseline and 3 days |
|
|
|
| Primary | Change From Baseline in Participant Red Cell Distribution Width (RDW) When Fasting and Fed | Posted | Mean | Standard Deviation | % of SD of MCV to mean MCV | Baseline and 3 days |
|
|
|
| Primary | Change From Baseline in Participant Mean Platelet Volume (MPV) When Fasting and Fed | Posted | Mean | Standard Deviation | fL | Baseline and 3 days |
|
|
|
| Primary | Change From Baseline in Participant Bicarbonate When Fasting and Fed | Posted | Mean | Standard Deviation | mmol/L | Baseline and 3 days |
|
|
|
| Primary | Change From Baseline in Participant Sodium When Fasting and Fed | Posted | Mean | Standard Deviation | mmol/L | Baseline and 3 days |
|
|
|
| Primary | Change From Baseline in Participant Chloride When Fasting and Fed | Posted | Mean | Standard Deviation | mmol/L | Baseline and 3 days |
|
|
|
| Primary | Change From Baseline in Participant Blood Urea Nitrogen (BUN) When Fasting and Fed | Posted | Mean | Standard Deviation | mg/dL | Baseline and 3 days |
|
|
|
| Primary | Change From Baseline in Participant Calcium When Fasting and Fed | Posted | Mean | Standard Deviation | mg/dL | Baseline and 3 days |
|
|
|
| Primary | Change From Baseline in Participant Potassium When Fasting and Fed | Posted | Mean | Standard Deviation | mmol/L | Baseline and 3 days |
|
|
|
| Primary | Change From Baseline in Participant Creatinine When Fasting and Fed | Posted | Mean | Standard Deviation | mg/dL | Baseline and 3 days |
|
|
|
| Primary | Change From Baseline in Participant Total Cholesterol (TC) When Fasting and Fed | Posted | Mean | Standard Deviation | mg/dL | Baseline and 3 days |
|
|
|
| Primary | Change From Baseline in Participant Low-Density Lipoprotein Cholesterol (LDL-C) When Fasting and Fed | Posted | Mean | Standard Deviation | mg/dL | Baseline and 3 days |
|
|
|
| Primary | Change From Baseline in Participant High-Density Lipoprotein Cholesterol (HDL-C) When Fasting and Fed | Posted | Mean | Standard Deviation | mg/dL | Baseline and 3 days |
|
|
|
| Primary | Change From Baseline in Participant Triglycerides When Fasting and Fed | Posted | Mean | Standard Deviation | mg/dL | Baseline and 3 days |
|
|
|
| Primary | Change From Baseline in Participant TC/HDL Ratio When Fasting and Fed | Posted | Mean | Standard Deviation | ratio | Baseline and 3 days |
|
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|
| Primary | Change From Baseline in Participant Weight When Fasting and Fed | Posted | Mean | Standard Deviation | kg | Baseline and 3 days |
|
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|
| Primary | Change From Baseline in Participant Waist Circumference When Fasting and Fed | Posted | Mean | Standard Deviation | cm | Baseline and 3 days |
|
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| Primary | Change From Baseline in Participant Systolic Blood Pressure (SBP), Supine When Fasting and Fed | Posted | Mean | Standard Deviation | mmHg | Baseline and 3 days |
|
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|
| Primary | Change From Baseline in Participant Diastolic Blood Pressure (DBP), Supine When Fasting and Fed | Posted | Mean | Standard Deviation | mmHg | Baseline and 3 days |
|
|
|
| Primary | Change From Baseline in Participant High Sensitivity C-Reactive Protein (hsCRP) When Fasting and Fed | Posted | Median | Standard Error | mg/L | Baseline and 3 days |
|
|
|
| 0 |
| 16 |
| 2 |
| 16 |
| EG001 | Fed Day First | Includes those who fasted on the 2nd day. | 0 | 14 | 1 | 14 |
| Migraine | General disorders | Non-systematic Assessment |
|
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| D006331 |
| Heart Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |