N/A N=30 Randomized Treatment

Expression of Longevity Genes in Response to Extended Fasting

Cardiovascular Disease

Bottom Line

View on ClinicalTrials.gov: NCT01059760 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2017

Primary outcome: Primary: Change From Baseline in Participant Glucose When Fasting and Fed — 83.3; -8.0; 5.9 mg/dL

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Fasting First (Behavioral); Fed First (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Intermountain Health Care, Inc.
Primary completion: Aug 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Participant Glucose When Fasting and Fed	83.3; -8.0; 5.9	—
PRIMARY Change From Baseline in Participant Human Growth Hormone (HGH) When Fasting and Fed	0.32; 1.54; -1.14	—
PRIMARY Change From Baseline in Participant Insulin When Fasting and Fed	23.6; -19.0; -1.6	—
PRIMARY Change From Baseline in Participant Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) When Fasting and Fed	0.66; -0.35; -.02	—
PRIMARY Change From Baseline in Participant Glycogen-Like Protein-1 (GLP-1) When Fasting and Fed	1.77; -0.27; 0.07	—
PRIMARY Change From Baseline in Participant Adiponectin When Fasting and Fed	0.34; 0.02; -0.07	—
PRIMARY Change From Baseline in Participant Fibroblast Growth Factor-21 (FGF-21) When Fasting and Fed	190.3; -41.7; 9.5	—
PRIMARY Change From Baseline in Participant White Blood Cell Count (WBC) When Fasting and Fed	6.0; 0.32; -0.12	—
PRIMARY Change From Baseline in Participant Hemoglobin When Fasting and Fed	14.3; 0.46; -0.39	—
PRIMARY Change From Baseline in Participant Red Blood Cell Count (RBC) When Fasting and Fed	4.7; 0.15; -0.11	—
PRIMARY Change From Baseline in Participant Hematocrit When Fasting and Fed	41.6; 1.3; -1.1	—
PRIMARY Change From Baseline in Participant Platelet Count When Fasting and Fed	253.5; 2.8; 0.9	—
PRIMARY Change From Baseline in Participant Mean Corpuscular Volume (MCV) When Fasting and Fed	89.11; -0.12; -0.18	—
PRIMARY Change From Baseline in Participant Mean Corpuscular Hemoglobin (MCH) When Fasting and Fed	30.66; -0.01; -0.07	—
PRIMARY Change From Baseline in Participant Mean Corpuscular Hemoglobin Concentration (MCHC) When Fasting and Fed	34.4; 0.02; -0.01	—
PRIMARY Change From Baseline in Participant Red Cell Distribution Width (RDW) When Fasting and Fed	13.6; -0.04; -0.03	—
PRIMARY Change From Baseline in Participant Mean Platelet Volume (MPV) When Fasting and Fed	8.17; 0.02; 0.03	—
PRIMARY Change From Baseline in Participant Bicarbonate When Fasting and Fed	27.0; -1.4; 0.9	—
PRIMARY Change From Baseline in Participant Sodium When Fasting and Fed	139.1; -1.4; 0.7	—
PRIMARY Change From Baseline in Participant Chloride When Fasting and Fed	103.7; -1.3; 0.9	—
PRIMARY Change From Baseline in Participant Blood Urea Nitrogen (BUN) When Fasting and Fed	16.0; -1.2; 1.8	—
PRIMARY Change From Baseline in Participant Calcium When Fasting and Fed	9.4; 0.18; -0.12	—
PRIMARY Change From Baseline in Participant Potassium When Fasting and Fed	4.29; -0.02; 0.02	—
PRIMARY Change From Baseline in Participant Creatinine When Fasting and Fed	0.848; 0.005; 0.002	—
PRIMARY Change From Baseline in Participant Total Cholesterol (TC) When Fasting and Fed	190.7; 9.5; -4.8	—
PRIMARY Change From Baseline in Participant Low-Density Lipoprotein Cholesterol (LDL-C) When Fasting and Fed	103.8; 23.1; -10.3	—
PRIMARY Change From Baseline in Participant High-Density Lipoprotein Cholesterol (HDL-C) When Fasting and Fed	55.9; 3.7; -1.0	—
PRIMARY Change From Baseline in Participant Triglycerides When Fasting and Fed	134.2; -52.4; 11.2	—
PRIMARY Change From Baseline in Participant TC/HDL Ratio When Fasting and Fed	3.63; -3.3; 0.0	—
PRIMARY Change From Baseline in Participant Weight When Fasting and Fed	81.3; -1.5; 0.5	—
PRIMARY Change From Baseline in Participant Waist Circumference When Fasting and Fed	86.7; -0.57; 0.54	—
PRIMARY Change From Baseline in Participant Systolic Blood Pressure (SBP), Supine When Fasting and Fed	114.0; -3.1; 1.0	—
PRIMARY Change From Baseline in Participant Diastolic Blood Pressure (DBP), Supine When Fasting and Fed	67.2; 1.7; -1.2	—
PRIMARY Change From Baseline in Participant High Sensitivity C-Reactive Protein (hsCRP) When Fasting and Fed	1.35; 0.00; -0.10	—

Summary

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

Eligibility Criteria

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 12 hours at a time) for at least a year, and does not deliberately skip meals as a routine dietary practice.

Exclusion Criteria

Body mass index 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01059760). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.