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

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