Fasting for Brain and Heart Health (FBHH)
- Conditions
- Insulin Resistance
- Interventions
- Other: Water-only Fasting
- Registration Number
- NCT04507516
- Lead Sponsor
- TrueNorth Health Foundation
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Water-only Fasting Cohort Water-only Fasting Obese/overweight, non-diabetic patients undergoing elective water-only fasting treatment.
- Primary Outcome Measures
Name Time Method Changes in insulin resistance from baseline Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast Insulin resistance assessed using serum glucose and insulin to calculate homeostatic model of insulin resistance (HOMA-IR) \[fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5\]
- Secondary Outcome Measures
Name Time Method Changes in weight from baseline Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast Weight measured on a digital scale and reported in kilograms (kg)
Changes in lipid profile from baseline Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast Lipid profile assessed using serum to measure cholesterol, triglycerides, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) and reported in mg/dL
Changes in high sensitivity C-reactive protein (hsCRP) from baseline Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast hsCRP assessed using serum and reported in mg/L
Changes in resting systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast SBP and DBP measured using digital blood pressure device and reported in mmHg
Changes in abdominal circumference from baseline Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast Abdominal circumference measured on bare skin at the minimal waistline with a tension-sensitive, non-elastic tape and reported in centimeters (cm)
Trial Locations
- Locations (1)
TrueNorth Health Center
🇺🇸Santa Rosa, California, United States