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.
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.
Study Type
OBSERVATIONAL
Enrollment
48
Water-only fasting for at least 10 days followed by 5 days of refeed.
TrueNorth Health Center
Santa Rosa, California, United States
Changes in insulin resistance from baseline
Insulin resistance assessed using serum glucose and insulin to calculate homeostatic model of insulin resistance (HOMA-IR) \[fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5\]
Time frame: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
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