The Effects of Water-only Fasting and Refeeding on Body Composition
Study Details
Study Description
Brief Summary
This observational pilot study will assess the effects of water-only fasting on body composition and insulin resistance
Condition or Disease | Intervention/Treatment | Phase |
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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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Water-only Fasting Group Overweight and obese, non-diabetic participants undergoing elective water-only fasting treatment |
Other: Water-only fasting
In-patient water-only fasting for at least 10 days followed by at least 5 days of refeeding
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Outcome Measures
- 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 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)
- 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 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 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Any gender
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40-70 years old
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Fasting plasma glucose <126mg/dL and/or hemoglobin A1c <7%
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BMI between 25 and 40 kg/m2
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Elect and qualify for a water-only fast of at least 10 consecutive days
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Provide informed consent
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Internet and computer access
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Able to return for 6-week follow-up visit
Exclusion Criteria:
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Active malignancy
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Active inflammatory disorder including classic autoimmune connective tissue (Lupus, Sjogrens, ANCA), multiple sclerosis, and inflammatory bowel disorders (Ulcerative colitis, Crohn's)
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Stroke or heart attack within the last 12 months
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Break water-only fast before 10 days with juice or food.
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Break water-only fast after 10 days with juice or food before end-of-fast blood draw occurs.
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Leave center before completing at least 5 days of refeeding
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Unable to lay still on the back for at least 10 min
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Abdominal metal implants
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Toshia Myers | Santa Rosa | California | United States | 95404 |
Sponsors and Collaborators
- TrueNorth Health Foundation
Investigators
- Principal Investigator: Toshia R Myers, PhD, Director
Study Documents (Full-Text)
None provided.More Information
Publications
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- de Mutsert R, Gast K, Widya R, de Koning E, Jazet I, Lamb H, le Cessie S, de Roos A, Smit J, Rosendaal F, den Heijer M. Associations of Abdominal Subcutaneous and Visceral Fat with Insulin Resistance and Secretion Differ Between Men and Women: The Netherlands Epidemiology of Obesity Study. Metab Syndr Relat Disord. 2018 Feb;16(1):54-63. doi: 10.1089/met.2017.0128. Epub 2018 Jan 17.
- Finnell JS, Saul BC, Goldhamer AC, Myers TR. Is fasting safe? A chart review of adverse events during medically supervised, water-only fasting. BMC Complement Altern Med. 2018 Feb 20;18(1):67. doi: 10.1186/s12906-018-2136-6.
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- TNHF2020-2VAT