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

T

TrueNorth Health Foundation

Status

Completed

Conditions

Visceral Obesity
Insulin Resistance

Treatments

Other: Water-only fasting

Study type

Observational

Funder types

Other

Identifiers

NCT04514146
TNHF2020-2VAT

Details and patient eligibility

About

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

Full 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.

Enrollment

48 patients

Sex

All

Ages

40 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

48 participants in 1 patient group

Water-only Fasting Group
Description:
Overweight and obese, non-diabetic participants undergoing elective water-only fasting treatment
Treatment:
Other: Water-only fasting

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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