Visceral Obesity, Insulin Resistance
Conditions
Keywords
water-only fasting, HOMA-IR, insulin resistance, visceral adipose tissue
Brief summary
This observational pilot study will assess the effects of water-only fasting on body composition and insulin resistance
Detailed description
This pilot study will explore the effects of water-only fasting followed by an exclusively whole-plant-food diet free of added salt, oil, and sugar on body composition with a particular focus on visceral adipose tissue (VAT). The study will also extend a previous study assessing the effects of fasting and refeeding on Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) values and markers of cardiovascular health and inflammation by following participants for an additional 6 weeks.
Interventions
OTHERWater-only fasting
In-patient water-only fasting for at least 10 days followed by at least 5 days of refeeding
Sponsors
TrueNorth Health Foundation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean changes in visceral adipose tissue from baseline | 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 | Visceral adipose tissue will be estimated using Holigic Horizon dual-energy X-ray absorptiometry (DXA) machine and reported in grams |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean changes in total fat and lean mass and bone mineral content (BMC) from baseline | 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 | Total fat and lean mass and BMC will be estimated using Holigic Horizon dual-energy X-ray absorptiometry (DXA) machine and reported in grams |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean changes in insulin resistance from baseline | 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 | Insulin resistance will be assessed using serum glucose and insulin to calculate homeostatic model of insulin resistance (HOMA-IR) \[fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5\] |
| Mean 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, 6-weeks after end of refeed | Abdominal circumference will be measured on bare skin at the minimal waistline with a tension-sensitive, non-elastic tape and reported in centimeters (cm) |
| Mean 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, 6-weeks after end of refeed | Lipid profile will be assessed using serum to measure cholesterol, triglycerides, high-density lipoprotein (HDL), and lowdensity lipoprotein (LDL) and reported in mg/dL |
| Mean changes in Gamma-Glutamyl-Transferase (GGT) from baseline | 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 | GGT will assessed using serum and reported in U/L |
| Mean changes in high sensitivity C-reactive protein (hs-CRP) from baseline | 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 | hsCRP will assessed using serum and reported in mg/L |
| Mean changes in weight from baseline | 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 | Weight will be measured on a digital scale and reported in kilograms (kg) |
Countries
United States
Outcome results
None listed