Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
48 participants
OBSERVATIONAL
2019-04-02
2020-02-10
Brief Summary
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Detailed Description
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This pilot study is designed to investigate the effect of water-only fasting and refeeding on the homeostatic model of insulin resistance (HOMA-IR), a measure of insulin resistance. Additionally, the study will assess if markers of cardiovascular health and inflammation change before and after water-only fasting. Water-only fasting participants will be recruited from patients who voluntarily elect to water-only fast for 10 or more consecutive days. Clinical variables and blood will be collected at baseline, every 7th day during fasting and refeeding, and the final day of fasting and refeeding.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Water-only Fasting Cohort
Obese/overweight, non-diabetic patients undergoing elective water-only fasting treatment.
Water-only Fasting
Water-only fasting for at least 10 days followed by 5 days of refeed.
Interventions
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Water-only Fasting
Water-only fasting for at least 10 days followed by 5 days of refeed.
Eligibility Criteria
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Inclusion Criteria
* 40-70 years old
* Fasting plasma glucose \<12 6mg/dL and/or hemoglobin A1c \<7%
* Body Mass Index (BMI) \>25 kg/m2
* Elect and qualify for a water-only fast of at least 10 consecutive days
* Provide informed consent
Exclusion Criteria
* Active inflammatory disorder including classic autoimmune connective tissue (Lupus, Sjogrens, ANCA), multiple sclerosis, and inflammatory bowel disorders (Ulcerative colitis, Crohn's)
* Stroke or heart attack within the last 90 days
40 Years
70 Years
ALL
No
Sponsors
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TrueNorth Health Foundation
OTHER
Responsible Party
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Principal Investigators
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Toshia R Myers, PhD
Role: PRINCIPAL_INVESTIGATOR
Director
Locations
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TrueNorth Health Center
Santa Rosa, California, United States
Countries
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Other Identifiers
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TNHF2018-1
Identifier Type: -
Identifier Source: org_study_id
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