Fasting for Brain and Heart Health (FBHH)

Insulin Resistance Clinical Trial

— FBHH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04507516
• Other study ID #: TNHF2018-1
• Status: Completed
• Start date: April 2, 2019
• Est. completion date: February 10, 2020

Study information

• Verified date: August 2020
• Source: TrueNorth Health Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 10, 2020
• Est. primary completion date: February 10, 2020
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Other:
• Water-only Fasting
Water-only fasting for at least 10 days followed by 5 days of refeed.

Locations

Country	Name	City	State
United States	TrueNorth Health Center	Santa Rosa	California

Sponsors (1)

Lead Sponsor	Collaborator
TrueNorth Health Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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