Fastomics: Metabolic and Therapeutic Effects of Prolonged Fasting

University of Minnesota (UMN)

Status: Enrolling

Conditions: Insulin Resistance; Fasting

Treatments: Other: Fasting

Study type: Observational

Funder types: Other

Identifiers

NCT07216989

MED-2025-33589

Details and patient eligibility

About

This is an observational study investigating how the metabolic and cell marker changes in Prolonged Fasting in the serum may be used against a cell-based model of disease for therapeutic purposes.

Full description

There is potential benefit to prolonged water fasting, fasting with ad libitum water intake and consciously eating little to no food or caloric beverages, with regards to reducing weight, fat mass, insulin resistance and oxidative stress while improving glycemic control. Multiple studies have shown that prolonged water-only Fasting for 5-20 days has been safe in humans. A minimum of 2-3 liters of water intake daily is recommended by previous studies in which longer periods of up to 8 days fasting were observed. Prolonged fasting (36 hours) in humans upregulated multiple bioactive metabolites in the serum; exposure to this serum extended the lifespan of yeast (Caenorhabditis elegans) by 96%. In patients receiving chemotherapy, extended fasting periods of up to 60 hours (36 hours before and 24 hours after chemotherapy) are well-tolerated and reduce chemotherapy-related side effects, similar to shorter fasting durations of 28-48 hours. Herein, we propose an in-depth evaluation of Prolonged Fasting on serum metabolite measures and the effects of these serum metabolites on different cell-based models of disease (i.e. cancer, metabolic syndrome, diabetes). We hypothesize that Prolonged Fasting will alter serum metabolites to favorably improve cell-based models of disease. The significance of this study is to understand the extent of immune system activation and metabolic changes resulting from Prolonged Fasting. This sets the stage for developing tailored interventions to capture the fasting phenotype without the process of actually fasting.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Ages of 18-65 years old
• Not pregnant
• No comorbid conditions
• BMI of 18.5-29.9.
• Has a smartphone

Exclusion criteria

• Concern for active eating disorder per screening questionnaire
• Self-reported eating disorder or history of eating disorder
• History of hypoglycemia or contraindication for Prolonged Fasting
• Weight <120lbs
• History of blood donation within the last 3 months.

Trial design

15 participants in 1 patient group

60 Hour Fasting

Description:

healthy participants who agree to fast with water for up to 60 hours while wearing continuous glucose monitors

Treatment:

Other: Fasting