Expression of Longevity Genes in Response to Extended Fasting

NCT01059760 | Completed Results

• 1 other identifier: 154-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiovascular Disease

Keywords

Fasting; Short-term starvation; Diet; Coronary artery disease

Outcome Measures

Primary Outcomes (34)

• 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

  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

Study Arms (2)

Fasting Day First

OTHER

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

Behavioral: Fasting First

Fed Day First

OTHER

28± 4 hours fed followed by 28± 4 hours of fasting

Behavioral: Fed First

Interventions

Fasting First BEHAVIORAL

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

Fasting Day First

Fed First BEHAVIORAL

28± 4 hours fed followed by 28± 4 hours of fasting

Fed Day First

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84107-5701, United States

Location

Related Publications (4)

• 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.

  PMID: 18805103 BACKGROUND

• 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.

  PMID: 39991046 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.

  PMID: 33512717 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.

  PMID: 23220077 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Fasting; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Benjamin D. Horne
• Organization: Intermountain Heart Institute

benjamin.horne@imail.org

8015074708

Study Officials

• Benjamin D Horne, PhD

  Intermountain Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2010
• First Posted: February 1, 2010
• Study Start: January 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: October 1, 2010
• Last Updated: July 17, 2017
• Results First Posted: July 17, 2017

Record last verified: 2011-03

Locations

US (1)