Insulin Resistance Clinical Trial
Official title:
A Pilot Study on the Effects of Water-only Fasting and Refeeding on Body Composition and Insulin Resistance
Verified date | October 2021 |
Source | TrueNorth Health Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This observational pilot study will assess the effects of water-only fasting on body composition and insulin resistance
Status | Completed |
Enrollment | 48 |
Est. completion date | October 1, 2021 |
Est. primary completion date | October 1, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility | Inclusion Criteria: - Any gender - 40-70 years old - Fasting plasma glucose <126mg/dL and/or hemoglobin A1c <7% - BMI between 25 and 40 kg/m2 - Elect and qualify for a water-only fast of at least 10 consecutive days - Provide informed consent - Internet and computer access - Able to return for 6-week follow-up visit Exclusion Criteria: - 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 12 months - Break water-only fast before 10 days with juice or food. - Break water-only fast after 10 days with juice or food before end-of-fast blood draw occurs. - Leave center before completing at least 5 days of refeeding - Unable to lay still on the back for at least 10 min - Abdominal metal implants |
Country | Name | City | State |
---|---|---|---|
United States | Toshia Myers | Santa Rosa | California |
Lead Sponsor | Collaborator |
---|---|
TrueNorth Health Foundation |
United States,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Mean changes in lipid profile from baseline | Lipid profile will be assessed using serum to measure cholesterol, triglycerides, high-density lipoprotein (HDL), and lowdensity lipoprotein (LDL) and reported in mg/dL | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast, 6-weeks after end of refeed | |
Other | Mean changes in weight from baseline | Weight will be measured on a digital scale and reported in kilograms (kg) | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast, 6-weeks after end of refeed | |
Other | Mean changes in insulin resistance from baseline | Insulin resistance will be 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, 6-weeks after end of refeed | |
Other | Mean changes in abdominal circumference from baseline | Abdominal circumference will be measured on bare skin at the minimal waistline with a tension-sensitive, non-elastic tape and reported in centimeters (cm) | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast, 6-weeks after end of refeed | |
Other | Mean changes in high sensitivity C-reactive protein (hs-CRP) from baseline | hsCRP will assessed using serum and reported in mg/L | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast, 6-weeks after end of refeed | |
Other | Mean changes in Gamma-Glutamyl-Transferase (GGT) from baseline | GGT will assessed using serum and reported in U/L | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast, 6-weeks after end of refeed | |
Primary | Mean changes in visceral adipose tissue from baseline | Visceral adipose tissue will be estimated using Holigic Horizon dual-energy X-ray absorptiometry (DXA) machine and reported in grams | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast, 6-weeks after end of refeed | |
Secondary | Mean changes in total fat and lean mass and bone mineral content (BMC) from baseline | Total fat and lean mass and BMC will be estimated using Holigic Horizon dual-energy X-ray absorptiometry (DXA) machine and reported in grams | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast, 6-weeks after end of refeed |
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