Fasting for Brain and Heart Health (FBHH) (FBHH)
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|ClinicalTrials.gov Identifier: NCT04507516|
Recruitment Status : Completed
First Posted : August 11, 2020
Last Update Posted : August 11, 2020
|Condition or disease||Intervention/treatment|
|Insulin Resistance||Other: Water-only Fasting|
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|
|Actual Enrollment :||48 participants|
|Official Title:||A Pilot Study on the Effects of Medically Supervised, Water-Only Fasting and Refeeding on Cardiometabolic Risk|
|Actual Study Start Date :||April 2, 2019|
|Actual Primary Completion Date :||February 10, 2020|
|Actual Study Completion Date :||February 10, 2020|
Water-only Fasting Cohort
Obese/overweight, non-diabetic patients undergoing elective water-only fasting treatment.
Other: Water-only Fasting
Water-only fasting for at least 10 days followed by 5 days of refeed.
- Changes in insulin resistance from baseline [ Time Frame: 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]
- Changes in lipid profile from baseline [ Time Frame: 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 weight from baseline [ Time Frame: 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 resting systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline [ Time Frame: 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 [ Time Frame: 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)
- Changes in high sensitivity C-reactive protein (hsCRP) from baseline [ Time Frame: 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
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04507516
|United States, California|
|TrueNorth Health Center|
|Santa Rosa, California, United States, 95404|
|Principal Investigator:||Toshia R Myers, PhD||Director|