Clinical trial NCT04514146: The Effects of Water-only Fasting and Refeeding on Body Composition
Official title: A Pilot Study on the Effects of Water-only Fasting and Refeeding on Body Composition and Insulin Resistance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Visceral Obesity
Insulin Resistance
Keywords: water-only fasting
HOMA-IR
insulin resistance
visceral adipose tissue
Lead sponsor: TrueNorth Health Foundation
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Overweight and obese, non-diabetic participants chosen from voluntary patients

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean changes in visceral adipose tissue from baseline
timeFrame: 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 outcomes:
measure: Mean changes in total fat and lean mass and bone mineral content (BMC) from baseline
timeFrame: 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 outcomes:
measure: Mean changes in lipid profile from baseline
timeFrame: 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
measure: Mean changes in weight from baseline
timeFrame: 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
measure: Mean changes in insulin resistance from baseline
timeFrame: 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
measure: Mean changes in abdominal circumference from baseline
timeFrame: 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
measure: Mean changes in high sensitivity C-reactive protein (hs-CRP) from baseline
timeFrame: 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
measure: Mean changes in Gamma-Glutamyl-Transferase (GGT) from baseline
timeFrame: 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
Locations:
city: Santa Rosa
country: United States
facility: Toshia Myers
state: California
Study officials:
affiliation: Director
name: Toshia R Myers, PhD
role: PRINCIPAL_INVESTIGATOR
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