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Completed

NCT Number: NCT01059760

Expression of Longevity Genes in Response to Extended Fasting

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

Completed

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Key information

Conditions

Cardiovascular Disease Arterial Occlusive Diseases Arteriosclerosis Behavior Cardiovascular Diseases Coronary Artery Disease Coronary Disease Fasting Feeding Behavior Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intermountain Medical Center

Murray, Utah, 84107-5701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Fasting First

Behavioral

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

Fed First

Behavioral

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

Primary outcomes

  1. Change From Baseline in Participant Glucose When Fasting and Fed

    Time frame: Baseline and 3 days

  2. Change From Baseline in Participant Human Growth Hormone (HGH) When Fasting and Fed

    Time frame: Baseline and 3 days

  3. Change From Baseline in Participant Insulin When Fasting and Fed

    Time frame: Baseline and 3 days

  4. 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

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

    Time frame: Baseline and 3 days

  6. Change From Baseline in Participant Adiponectin When Fasting and Fed

    Time frame: Baseline and 3 days

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

    Time frame: Baseline and 3 days

  8. Change From Baseline in Participant White Blood Cell Count (WBC) When Fasting and Fed

    Time frame: Baseline and 3 days

  9. Change From Baseline in Participant Hemoglobin When Fasting and Fed

    Time frame: Baseline and 3 days

  10. Change From Baseline in Participant Red Blood Cell Count (RBC) When Fasting and Fed

    Time frame: Baseline and 3 days

  11. Change From Baseline in Participant Hematocrit When Fasting and Fed

    Time frame: Baseline and 3 days

  12. Change From Baseline in Participant Platelet Count When Fasting and Fed

    Time frame: Baseline and 3 days

  13. Change From Baseline in Participant Mean Corpuscular Volume (MCV) When Fasting and Fed

    Time frame: Baseline and 3 days

  14. Change From Baseline in Participant Mean Corpuscular Hemoglobin (MCH) When Fasting and Fed

    Time frame: Baseline and 3 days

  15. Change From Baseline in Participant Mean Corpuscular Hemoglobin Concentration (MCHC) When Fasting and Fed

    Time frame: Baseline and 3 days

  16. Change From Baseline in Participant Red Cell Distribution Width (RDW) When Fasting and Fed

    Time frame: Baseline and 3 days

  17. Change From Baseline in Participant Mean Platelet Volume (MPV) When Fasting and Fed

    Time frame: Baseline and 3 days

  18. Change From Baseline in Participant Bicarbonate When Fasting and Fed

    Time frame: Baseline and 3 days

  19. Change From Baseline in Participant Sodium When Fasting and Fed

    Time frame: Baseline and 3 days

  20. Change From Baseline in Participant Chloride When Fasting and Fed

    Time frame: Baseline and 3 days

  21. Change From Baseline in Participant Blood Urea Nitrogen (BUN) When Fasting and Fed

    Time frame: Baseline and 3 days

  22. Change From Baseline in Participant Calcium When Fasting and Fed

    Time frame: Baseline and 3 days

  23. Change From Baseline in Participant Potassium When Fasting and Fed

    Time frame: Baseline and 3 days

  24. Change From Baseline in Participant Creatinine When Fasting and Fed

    Time frame: Baseline and 3 days

  25. Change From Baseline in Participant Total Cholesterol (TC) When Fasting and Fed

    Time frame: Baseline and 3 days

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

    Time frame: Baseline and 3 days

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

    Time frame: Baseline and 3 days

  28. Change From Baseline in Participant Triglycerides When Fasting and Fed

    Time frame: Baseline and 3 days

  29. Change From Baseline in Participant TC/HDL Ratio When Fasting and Fed

    Time frame: Baseline and 3 days

  30. Change From Baseline in Participant Weight When Fasting and Fed

    Time frame: Baseline and 3 days

  31. Change From Baseline in Participant Waist Circumference When Fasting and Fed

    Time frame: Baseline and 3 days

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

    Time frame: Baseline and 3 days

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

    Time frame: Baseline and 3 days

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

    Time frame: Baseline and 3 days

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Registry information

Acronym: FEELGOOD

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 1, 2010
Registry last updated
Jul 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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