ClinicalTrials.gg
CompletedNCT07216989Updated Jul 14, 2026

Fastomics: Metabolic and Therapeutic Effects of Prolonged Fasting

An observational study in Insulin Resistance and Fasting, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by University of Minnesota · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
14
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Insulin Resistance
  • Fasting
03

In context

Insulin Resistance

2,969 studies on the registry are indexed under Insulin Resistance; 338 are open to participants now.

This study's enrollment of 14 is below the median of 82 across 478 observational studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.

Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Self-reportedly healthy subjects

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Concern for active eating disorder per screening questionnaire
  • Self-reported eating disorder or history of eating disorder
  • History of hypoglycemia or for Prolonged Fasting
  • Weight \<120lbs
  • History of blood donation within the last 3 months.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
14 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 60 Hour Fasting

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

    Other: Fasting

Interventions

  • OtherFasting

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

06

What researchers measure

Primary outcomes

  1. Feasibility of doing prolonged fasting in this population

    measured by % participants completing all the visits

    Time frame: Day 4

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

    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.

    Time frame: Baseline

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

    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.

    Time frame: After 60 hours of fasting

07

Study locations

1 site
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2025 to primary completion in Mar 2026, 7 months.

Of 130 non-industry observational studies under Insulin Resistance, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 142. This study's 7 months is below that.

Counting every sponsor, half of 133 studies reached it within 53 months; a quarter within 18 and three quarters within 143.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 22, 2025
First posted
Oct 15, 2025
StartActual
Aug 5, 2025
Primary completionActual
Mar 19, 2026
CompletionActual
Mar 19, 2026
Last update
Jul 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07216989
Responsible party
Sponsor
First posted
Oct 15, 2025
Start date
Aug 5, 2025
Primary completion
Mar 19, 2026
Completion
Mar 19, 2026
Last update
Jul 14, 2026

Study contacts

Lisa Chow, MD, MS
principal investigator · University of Minnesota

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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