Fastomics: Metabolic and Therapeutic Effects of Prolonged Fasting
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversity of Minnesota
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Ages of 18-65 years old
Not pregnant
No comorbid conditions
BMI of 18.5-29.9.
Disqualifiers
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
Trial population
Self-reportedly healthy subjects
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Fasting
Other interventionfast with water for up to 60 hours while wearing continuous glucose monitors
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: 60 Hour Fasting1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of doing prolonged fasting in this population
measured by % participants completing all the visits
Time frame
Day 4Secondary 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
Baseline2
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 fastingSponsors and contacts
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Source ClinicalTrials.gov