Fastomics: Metabolic and Therapeutic Effects of Prolonged Fasting

Recruiting

• Conditions: Insulin Resistance; Fasting

• Registration Number: NCT07216989
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study Start: 2025-08-05
• Study First Submitted: 2025-09-22
• Status Verified: 2025-10
• Study First Submitted QC: 2025-10-13
• Last Update Submitted: 2025-10-13
• Study First Posted: 2025-10-15
• Last Update Posted: 2025-10-15
• Primary Completion: 2026-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of doing prolonged fasting in this population	Day 4	measured by % participants completing all the visits

Secondary Outcome Measures

Name	Time	Method
Exposure of plasma on in vitro breast cancer cell models with regards to cell viability, signaling, function, plasma metabolites, and inflammatory markers	After 60 hours of fasting	Exposure of cancer cell lines in combination with various doses of chemotherapy agents (e.g., doxorubicin). potential example measures include the following: Serum samples will be analyzed with a Meso Scale Discovery V-PLEX Proinflammatory Panel, which measures the following markers of inflammation: IFN-γ, IL-1β, IL- 2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13,TNF-α.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States