The Effects of Water-only Fasting and Refeeding on Body Composition

Study Overview
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Brief Summary
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This observational pilot study will assess the effects of water-only fasting on body composition and insulin resistance

Detailed Description
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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.

Official Title
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A Pilot Study on the Effects of Water-only Fasting and Refeeding on Body Composition and Insulin Resistance

Conditions
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Visceral Obesity, Insulin Resistance

Intervention / Treatment
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* Other: Water-only fasting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Water-only Fasting Group<br>Overweight and obese, non-diabetic participants undergoing elective water-only fasting treatment | Other: Water-only fasting<br>* In-patient water-only fasting for at least 10 days followed by at least 5 days of refeeding<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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water-only fasting, HOMA-IR, insulin resistance, visceral adipose tissue