Fasting for Brain and Heart Health (FBHH)

TrueNorth Health Foundation

Status: Completed

Conditions: Insulin Resistance

Treatments: Other: Water-only Fasting

Study type: Observational

Funder types: Other

Identifiers

NCT04507516

TNHF2018-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

48 participants in 1 patient group

Water-only Fasting Cohort

Description:

Obese/overweight, non-diabetic patients undergoing elective water-only fasting treatment.

Treatment:

Other: Water-only Fasting