Fasting for Brain and Heart Health (FBHH) (FBHH)

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

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.

Study Overview

• Status: Completed
• Conditions: Insulin Resistance
• Intervention / Treatment: Other: Water-only Fasting

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.

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Rosa, California, United States, 95404
      • TrueNorth Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Overweight and obese, non-diabetic participants recruited from voluntary patients.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: TrueNorth Health Foundation

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2019
• Primary Completion (Actual): February 10, 2020
• Study Completion (Actual): February 10, 2020

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: August 7, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Actual): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 7, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: TNHF2018-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No