Fastomics: Metabolic and Therapeutic Effects of Prolonged Fasting

NCT ID: NCT07216989

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-05
• Study Completion Date: 2026-10-01

Brief Summary

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.

Detailed 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.

Conditions

Insulin Resistance; Fasting

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

60 Hour Fasting

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

Fasting

Intervention Type: OTHER

fast with water for up to 60 hours while wearing continuous glucose monitors

Interventions

Fasting

fast with water for up to 60 hours while wearing continuous glucose monitors

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Chow, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lesia Lysne

Role: CONTACT

endores@umn.edu

612-523-5844

Facility Contacts

Lesia Lysne

Role: primary

endores@umn.edu

612-523-5844

Other Identifiers

MED-2025-33589

Identifier Type: -

Identifier Source: org_study_id