NCT04507516

Fasting for Brain and Heart Health (FBHH)

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 48 (actual)
• Sponsor: TrueNorth Health Foundation · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: —

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.

Conditions

• Insulin Resistance

Interventions

Type	Name	Description
OTHER	Water-only Fasting	Water-only fasting for at least 10 days followed by 5 days of refeed.

Timeline

• Start date: 2019-04-02
• Primary completion: 2020-02-10
• Completion: 2020-02-10
• First posted: 2020-08-11
• Last updated: 2020-08-11

Locations

1 site across 1 country: United States