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

Completed

• Conditions: Visceral Obesity; Insulin Resistance
• Interventions: Other: Water-only fasting

• Registration Number: NCT04514146
• Lead Sponsor: TrueNorth Health Foundation

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.

Study Timeline

• Study First Submitted: 2020-08-12
• Study First Submitted QC: 2020-08-12
• Study First Posted: 2020-08-14
• Study Start: 2020-08-15
• Status Verified: 2021-10
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Toshia Myers; 🇺🇸 Santa Rosa, California, United States