NCT07216989

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 5, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 15, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2026

Completed
Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

8 months

First QC Date

September 22, 2025

Last Update Submit

July 13, 2026

Conditions

FastingInsulin Resistance

Outcome Measures

Primary Outcomes (1)

  • Feasibility of doing prolonged fasting in this population

    measured by % participants completing all the visits

    Day 4

Secondary Outcomes (2)

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

    Baseline

  • 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

Study Arms (1)

60 Hour Fasting

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

Other: Fasting

Interventions

FastingOTHER

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

60 Hour Fasting

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Self-reportedly healthy subjects

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples will be stored, with participant consent, deidentified in freezers under the care of the PI indefinitely

MeSH Terms

Conditions

Insulin ResistanceFasting

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesFeeding BehaviorBehavior

Study Officials

  • Lisa Chow, MD, MS

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2025

First Posted

October 15, 2025

Study Start

August 5, 2025

Primary Completion

March 19, 2026

Study Completion

March 19, 2026

Last Updated

July 14, 2026

Record last verified: 2026-07

Locations

US(1)