Fasting for Brain and Heart Health (FBHH)
FBHH
A Pilot Study on the Effects of Medically Supervised, Water-Only Fasting and Refeeding on Cardiometabolic Risk
1 other identifier
observational
48
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2020
CompletedFirst Submitted
Initial submission to the registry
August 6, 2020
CompletedFirst Posted
Study publicly available on registry
August 11, 2020
CompletedAugust 11, 2020
August 1, 2020
10 months
August 6, 2020
August 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in insulin resistance from baseline
Insulin resistance assessed using serum glucose and insulin to calculate homeostatic model of insulin resistance (HOMA-IR) \[fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5\]
Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
Secondary Outcomes (5)
Changes in lipid profile from baseline
Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
Changes in weight from baseline
Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
Changes in resting systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline
Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
Changes in abdominal circumference from baseline
Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
Changes in high sensitivity C-reactive protein (hsCRP) from baseline
Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
Study Arms (1)
Water-only Fasting Cohort
Obese/overweight, non-diabetic patients undergoing elective water-only fasting treatment.
Interventions
Water-only fasting for at least 10 days followed by 5 days of refeed.
Eligibility Criteria
Overweight and obese, non-diabetic participants recruited from voluntary patients.
You may qualify if:
- Any gender
- 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
You may not qualify if:
- Active malignancy
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
TrueNorth Health Center
Santa Rosa, California, 95404, United States
Biospecimen
plasma, sera
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Toshia R Myers, PhD
Director
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2020
First Posted
August 11, 2020
Study Start
April 2, 2019
Primary Completion
February 10, 2020
Study Completion
February 10, 2020
Last Updated
August 11, 2020
Record last verified: 2020-08