CompletedNCT01059760FEELGOODUpdated Jul 17, 2017Results posted

Expression of Longevity Genes in Response to Extended Fasting

An interventional study of Fasting First and Fed First in Cardiovascular Disease, sponsored by Intermountain Health Care, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-17.

Sponsored by Intermountain Health Care, Inc. · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study summary

The purpose of this study is to evaluate the effect of fasting on physical changes associated with cardiovascular disease.

Read the 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.

Conditions studied

Cardiovascular Disease

Browse trials for

Cardiovascular Diseases 4,904

Keywords

Fasting
Short-term starvation
Diet
Coronary artery disease

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 30 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Intermountain Health Care, Inc. is the lead sponsor of 118 studies on the registry; 15 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

The volunteer (male or non-pregnant female, any ethnicity) must be >18 years of age.
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]).
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

Exclusion Criteria:

Body mass index \<18.5 or >35 kg/m2.
Current active cancer treatment, treatment with immunosuppressive medications, or solid organ transplantation within 1 year.
Presence of immunosuppressive disease, myocardial infarction, peripheral vascular disease, or stroke within the past year.
Use of insulin.
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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 30 participants (actual)

Study arms

Other
Fasting Day First
28±4 hours of water-only fasting followed by 28±4 hours fed
Behavioral: Fasting First
Other
Fed Day First
28± 4 hours fed followed by 28± 4 hours of fasting
Behavioral: Fed First

Interventions

BehavioralFasting First
28±4 hours of water-only fasting followed by 28±4 hours fed
BehavioralFed First
28± 4 hours fed followed by 28± 4 hours of fasting

What researchers measure

Primary outcomes

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
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
Time frame: Baseline and 3 days
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

Results

Posted Jul 17, 2017

Participant flow

Participant flow — Overall Study
Milestone	Fasting Day First	Fed Day First
Started	16	14
Completed	16	14
Not completed	0	0

Outcome measures

PrimaryChange From Baseline in Participant Glucose When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · mg/dL

Change From Baseline in Participant Glucose When Fasting and Fed
mg/dL	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Glucose When Fasting and Fed	83.3 ± 15.8	-8.0 ± 15.4	5.9 ± 16.6

PrimaryChange From Baseline in Participant Human Growth Hormone (HGH) When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · ng/mL

Change From Baseline in Participant Human Growth Hormone (HGH) When Fasting and Fed
ng/mL	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Human Growth Hormone (HGH) When Fasting and Fed	0.32 ± 0.47	1.54 ± 2.63	-1.14 ± 1.66

PrimaryChange From Baseline in Participant Insulin When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · mU/L

Change From Baseline in Participant Insulin When Fasting and Fed
mU/L	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Insulin When Fasting and Fed	23.6 ± 17.8	-19.0 ± 29.3	-1.6 ± 16.2

PrimaryChange 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

Time frame:: Baseline and 3 days
Reported as:: Mean · units on a scale

Change From Baseline in Participant Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) When Fasting and Fed
units on a scale	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) When Fasting and Fed	0.66 ± 0.051	-0.35 ± 0.53	-.02 ± 0.30

PrimaryChange From Baseline in Participant Glycogen-Like Protein-1 (GLP-1) When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · ng/mL

Change From Baseline in Participant Glycogen-Like Protein-1 (GLP-1) When Fasting and Fed
ng/mL	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Glycogen-Like Protein-1 (GLP-1) When Fasting and Fed	1.77 ± 0.79	-0.27 ± 0.51	0.07 ± 0.51

PrimaryChange From Baseline in Participant Adiponectin When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · ratio of high molecular to total

Change From Baseline in Participant Adiponectin When Fasting and Fed
ratio of high molecular to total	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Adiponectin When Fasting and Fed	0.34 ± 0.17	0.02 ± 0.25	-0.07 ± 0.25

PrimaryChange From Baseline in Participant Fibroblast Growth Factor-21 (FGF-21) When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · pg/mL

Change From Baseline in Participant Fibroblast Growth Factor-21 (FGF-21) When Fasting and Fed
pg/mL	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Fibroblast Growth Factor-21 (FGF-21) When Fasting and Fed	190.3 ± 261.4	-41.7 ± 128.9	9.5 ± 108.8

PrimaryChange From Baseline in Participant White Blood Cell Count (WBC) When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · cells/mL

Change From Baseline in Participant White Blood Cell Count (WBC) When Fasting and Fed
cells/mL	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant White Blood Cell Count (WBC) When Fasting and Fed	6.0 ± 1.4	0.32 ± 1.31	-0.12 ± 1.48

PrimaryChange From Baseline in Participant Hemoglobin When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · g/dL

Change From Baseline in Participant Hemoglobin When Fasting and Fed
g/dL	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Hemoglobin When Fasting and Fed	14.3 ± 1.3	0.46 ± 0.37	-0.39 ± 0.52

PrimaryChange From Baseline in Participant Red Blood Cell Count (RBC) When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · cells x 10^6/mL

Change From Baseline in Participant Red Blood Cell Count (RBC) When Fasting and Fed
cells x 10^6/mL	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Red Blood Cell Count (RBC) When Fasting and Fed	4.7 ± 0.4	0.15 ± 0.13	-0.11 ± 0.17

PrimaryChange From Baseline in Participant Hematocrit When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · % of red blood cells to whole blood

Change From Baseline in Participant Hematocrit When Fasting and Fed
% of red blood cells to whole blood	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Hematocrit When Fasting and Fed	41.6 ± 3.6	1.3 ± 1.3	-1.1 ± 1.5

PrimaryChange From Baseline in Participant Platelet Count When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · cells x 10^3/mL

Change From Baseline in Participant Platelet Count When Fasting and Fed
cells x 10^3/mL	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Platelet Count When Fasting and Fed	253.5 ± 58.2	2.8 ± 16.3	0.9 ± 13.8

PrimaryChange From Baseline in Participant Mean Corpuscular Volume (MCV) When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · fL

Change From Baseline in Participant Mean Corpuscular Volume (MCV) When Fasting and Fed
fL	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Mean Corpuscular Volume (MCV) When Fasting and Fed	89.11 ± 3.56	-0.12 ± 0.68	-0.18 ± 0.73

PrimaryChange From Baseline in Participant Mean Corpuscular Hemoglobin (MCH) When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · pg

Change From Baseline in Participant Mean Corpuscular Hemoglobin (MCH) When Fasting and Fed
pg	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Mean Corpuscular Hemoglobin (MCH) When Fasting and Fed	30.66 ± 1.48	-0.01 ± 0.33	-0.07 ± 0.40

PrimaryChange From Baseline in Participant Mean Corpuscular Hemoglobin Concentration (MCHC) When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · g/dL

Change From Baseline in Participant Mean Corpuscular Hemoglobin Concentration (MCHC) When Fasting and Fed
g/dL	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Mean Corpuscular Hemoglobin Concentration (MCHC) When Fasting and Fed	34.4 ± 0.5	0.02 ± 0.49	-0.01 ± 0.52

PrimaryChange From Baseline in Participant Red Cell Distribution Width (RDW) When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · % of SD of MCV to mean MCV

Change From Baseline in Participant Red Cell Distribution Width (RDW) When Fasting and Fed
% of SD of MCV to mean MCV	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Red Cell Distribution Width (RDW) When Fasting and Fed	13.6 ± 0.82	-0.04 ± 0.32	-0.03 ± 0.37

PrimaryChange From Baseline in Participant Mean Platelet Volume (MPV) When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · fL

Change From Baseline in Participant Mean Platelet Volume (MPV) When Fasting and Fed
fL	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Mean Platelet Volume (MPV) When Fasting and Fed	8.17 ± 0.83	0.02 ± 0.49	0.03 ± 0.26

PrimaryChange From Baseline in Participant Bicarbonate When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · mmol/L

Change From Baseline in Participant Bicarbonate When Fasting and Fed
mmol/L	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Bicarbonate When Fasting and Fed	27.0 ± 2.5	-1.4 ± 1.7	0.9 ± 2.2

PrimaryChange From Baseline in Participant Sodium When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · mmol/L

Change From Baseline in Participant Sodium When Fasting and Fed
mmol/L	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Sodium When Fasting and Fed	139.1 ± 2.0	-1.4 ± 2.1	0.7 ± 2.0

PrimaryChange From Baseline in Participant Chloride When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · mmol/L

Change From Baseline in Participant Chloride When Fasting and Fed
mmol/L	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Chloride When Fasting and Fed	103.7 ± 2.7	-1.3 ± 2.0	0.9 ± 2.3

PrimaryChange From Baseline in Participant Blood Urea Nitrogen (BUN) When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · mg/dL

Change From Baseline in Participant Blood Urea Nitrogen (BUN) When Fasting and Fed
mg/dL	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Blood Urea Nitrogen (BUN) When Fasting and Fed	16.0 ± 3.7	-1.2 ± 3.9	1.8 ± 2.6

PrimaryChange From Baseline in Participant Calcium When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · mg/dL

Change From Baseline in Participant Calcium When Fasting and Fed
mg/dL	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Calcium When Fasting and Fed	9.4 ± 0.3	0.18 ± 0.34	-0.12 ± 0.33

PrimaryChange From Baseline in Participant Potassium When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · mmol/L

Change From Baseline in Participant Potassium When Fasting and Fed
mmol/L	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Potassium When Fasting and Fed	4.29 ± 0.28	-0.02 ± 0.30	0.02 ± 0.32

PrimaryChange From Baseline in Participant Creatinine When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · mg/dL

Change From Baseline in Participant Creatinine When Fasting and Fed
mg/dL	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Creatinine When Fasting and Fed	0.848 ± 0.118	0.005 ± 0.09	0.002 ± 0.06

PrimaryChange From Baseline in Participant Total Cholesterol (TC) When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · mg/dL

Change From Baseline in Participant Total Cholesterol (TC) When Fasting and Fed
mg/dL	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Total Cholesterol (TC) When Fasting and Fed	190.7 ± 30.7	9.5 ± 10.6	-4.8 ± 11.0

PrimaryChange From Baseline in Participant Low-Density Lipoprotein Cholesterol (LDL-C) When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · mg/dL

Change From Baseline in Participant Low-Density Lipoprotein Cholesterol (LDL-C) When Fasting and Fed
mg/dL	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Low-Density Lipoprotein Cholesterol (LDL-C) When Fasting and Fed	103.8 ± 33.8	23.1 ± 35.1	-10.3 ± 28.2

PrimaryChange From Baseline in Participant High-Density Lipoprotein Cholesterol (HDL-C) When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · mg/dL

Change From Baseline in Participant High-Density Lipoprotein Cholesterol (HDL-C) When Fasting and Fed
mg/dL	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant High-Density Lipoprotein Cholesterol (HDL-C) When Fasting and Fed	55.9 ± 14.3	3.7 ± 5.3	-1.0 ± 3.6

PrimaryChange From Baseline in Participant Triglycerides When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · mg/dL

Change From Baseline in Participant Triglycerides When Fasting and Fed
mg/dL	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Triglycerides When Fasting and Fed	134.2 ± 77.0	-52.4 ± 55.5	11.2 ± 38.1

PrimaryChange From Baseline in Participant TC/HDL Ratio When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · ratio

Change From Baseline in Participant TC/HDL Ratio When Fasting and Fed
ratio	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant TC/HDL Ratio When Fasting and Fed	3.63 ± 1.15	-3.3 ± 17.7	0.0 ± 0.2

PrimaryChange From Baseline in Participant Weight When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · kg

Change From Baseline in Participant Weight When Fasting and Fed
kg	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Weight When Fasting and Fed	81.3 ± 25.0	-1.5 ± 0.9	0.5 ± 0.9

PrimaryChange From Baseline in Participant Waist Circumference When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · cm

Change From Baseline in Participant Waist Circumference When Fasting and Fed
cm	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Waist Circumference When Fasting and Fed	86.7 ± 16.7	-0.57 ± 1.4	0.54 ± 3.0

PrimaryChange From Baseline in Participant Systolic Blood Pressure (SBP), Supine When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · mmHg

Change From Baseline in Participant Systolic Blood Pressure (SBP), Supine When Fasting and Fed
mmHg	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Systolic Blood Pressure (SBP), Supine When Fasting and Fed	114.0 ± 13.6	-3.1 ± 8.4	1.0 ± 9.6

PrimaryChange From Baseline in Participant Diastolic Blood Pressure (DBP), Supine When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Mean · mmHg

Change From Baseline in Participant Diastolic Blood Pressure (DBP), Supine When Fasting and Fed
mmHg	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant Diastolic Blood Pressure (DBP), Supine When Fasting and Fed	67.2 ± 8.8	1.7 ± 7.4	-1.2 ± 8.9

PrimaryChange From Baseline in Participant High Sensitivity C-Reactive Protein (hsCRP) When Fasting and Fed

Time frame:: Baseline and 3 days
Reported as:: Median · mg/L

Change From Baseline in Participant High Sensitivity C-Reactive Protein (hsCRP) When Fasting and Fed
mg/L	Baseline Value	Change While Fasting	Change When Fed
Change From Baseline in Participant High Sensitivity C-Reactive Protein (hsCRP) When Fasting and Fed	1.35 ± 0.96	0.00 ± 0.44	-0.10 ± 0.24

Adverse events

Collected over 3 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Fasting Day First	—	0/16 (0%)	2/16 (12.5%)
Fed Day First	—	0/14 (0%)	1/14 (7.1%)

Most frequent other events

Most frequent other events
Event	Fasting Day First	Fed Day First
Mild HeadacheGeneral disorders	1/16	1/14
MigraineGeneral disorders	1/16	0/14

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Fasting Day First	Fed Day First	Total
Mean	43.3 ± 13.6	44.0 ± 14.0	43.6 ± 13.5

Sex: Female, Male
Sex: Female, Male(Participants)	Fasting Day First	Fed Day First	Total
Female	11	9	20
Male	5	5	10

Region of Enrollment
Region of Enrollment(participants)	Fasting Day First	Fed Day First	Total
United States	16	14	30

Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)	Fasting Day First	Fed Day First	Total
Mean	28.4 ± 7.1	27.3 ± 6.1	27.8 ± 1.3

Hemoglobin A1C
Hemoglobin A1C(percentage)	Fasting Day First	Fed Day First	Total
Mean	5.5 ± 0.3	5.3 ± 0.3	5.4 ± 0.3

Study locations

1 site

Intermountain Medical Center
Murray, Utah 84107-5701, United States

References and documents

Publications

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. PubMed 18805103 ↗
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. PubMed 33512717 ↗
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. PubMed 23220077 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01059760
Lead sponsor: Intermountain Health Care, Inc.
Responsible party: Sponsor
First posted: Feb 1, 2010
Start date: Jan 2010
Primary completion: Aug 2010
Completion: Oct 2010
Results posted: Jul 17, 2017
Last update: Jul 17, 2017

Study contacts

Benjamin D Horne, PhD

principal investigator · Intermountain Medical Center

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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