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Completed

NCT Number: NCT07216989

Fastomics: Metabolic and Therapeutic Effects of Prolonged Fasting

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fasting

Other

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

Primary outcomes

  1. Feasibility of doing prolonged fasting in this population

    Time frame: Day 4

    measured by % participants completing all the visits

Secondary outcomes

  1. Exposure of plasma on in vitro breast cancer cell models with regards to cell viability, signaling, function, plasma metabolites, and inflammatory markers

    Time frame: Baseline

    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.

  2. Exposure of plasma on in vitro breast cancer cell models with regards to cell viability, signaling, function, plasma metabolites, and inflammatory markers

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 15, 2025
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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