Fasting for Brain and Heart Health (FBHH)

Study Overview
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Brief Summary
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This pilot study is designed to investigate the effect of water-only fasting and refeeding on the homeostatic model of insulin resistance (HOMA-IR), a measure of insulin resistance.

Detailed Description
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Ischemic stroke is a leading cause of death and a major public health burden. Data suggests that insulin resistance is a potential risk factor for cardiovascular disease, including ischemic stroke, and that dietary and lifestyle intervention can reduce insulin resistance as well as these disease risks. Nonetheless, current intervention strategies have done little to reduce overall stroke incidence. Therefore, an intervention, such as prolonged medically supervised water-only fasting, might be an effective strategy to both reduce insulin resistance and encourage dietary and lifestyle changes that reduce incidence of stroke. This pilot study is designed to investigate the effect of water-only fasting and refeeding on the homeostatic model of insulin resistance (HOMA-IR), a measure of insulin resistance. Additionally, the study will assess if markers of cardiovascular health and inflammation change before and after water-only fasting. Water-only fasting participants will be recruited from patients who voluntarily elect to water-only fast for 10 or more consecutive days. Clinical variables and blood will be collected at baseline, every 7th day during fasting and refeeding, and the final day of fasting and refeeding.

Official Title
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A Pilot Study on the Effects of Medically Supervised, Water-Only Fasting and Refeeding on Cardiometabolic Risk

Conditions
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Insulin Resistance

Intervention / Treatment
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* Other: Water-only Fasting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any gender 40-70 years old Fasting plasma glucose <12 6mg/dL and/or hemoglobin A1c <7% Body Mass Index (BMI) >25 kg/m2 Elect and qualify for a water-only fast of at least 10 consecutive days Provide informed consent Exclusion Criteria: Active malignancy Active inflammatory disorder including classic autoimmune connective tissue (Lupus, Sjogrens, ANCA), multiple sclerosis, and inflammatory bowel disorders (Ulcerative colitis, Crohn's) Stroke or heart attack within the last 90 days

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Water-only Fasting Cohort<br>Obese/overweight, non-diabetic patients undergoing elective water-only fasting treatment. | Other: Water-only Fasting<br>* Water-only fasting for at least 10 days followed by 5 days of refeed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in insulin resistance from baseline | Insulin resistance assessed using serum glucose and insulin to calculate homeostatic model of insulin resistance (HOMA-IR) [fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5] | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in lipid profile from baseline | Lipid profile assessed using serum to measure cholesterol, triglycerides, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) and reported in mg/dL | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast | 
| Changes in weight from baseline | Weight measured on a digital scale and reported in kilograms (kg) | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast | 
| Changes in resting systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline | SBP and DBP measured using digital blood pressure device and reported in mmHg | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast | 
| Changes in abdominal circumference from baseline | Abdominal circumference measured on bare skin at the minimal waistline with a tension-sensitive, non-elastic tape and reported in centimeters (cm) | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast | 
| Changes in high sensitivity C-reactive protein (hsCRP) from baseline | hsCRP assessed using serum and reported in mg/L | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast |