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Trials / Recruiting

RecruitingNCT07216989

Fastomics: Metabolic and Therapeutic Effects of Prolonged Fasting

Status
Recruiting
Phase
Study type
Observational
Enrollment
15 (estimated)
Sponsor
University of Minnesota · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

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

Interventions

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

Timeline

Start date
2025-08-05
Primary completion
2026-10-01
Completion
2026-10-01
First posted
2025-10-15
Last updated
2025-10-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07216989. Inclusion in this directory is not an endorsement.