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

Sponsor
TrueNorth Health Foundation (Other)
Overall Status
Completed
CT.gov ID
NCT04514146
Collaborator
(none)
48
1
13.5
3.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Water-only fasting

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 Design

Study Type:
Observational
Actual Enrollment :
48 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Pilot Study on the Effects of Water-only Fasting and Refeeding on Body Composition and Insulin Resistance
Actual Study Start Date :
Aug 15, 2020
Actual Primary Completion Date :
Oct 1, 2021
Actual Study Completion Date :
Oct 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Water-only Fasting Group

Overweight and obese, non-diabetic participants undergoing elective water-only fasting treatment

Other: Water-only fasting
In-patient water-only fasting for at least 10 days followed by at least 5 days of refeeding

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Other Outcome Measures

  1. Mean changes in lipid profile 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]

    Lipid profile will be assessed using serum to measure cholesterol, triglycerides, high-density lipoprotein (HDL), and lowdensity lipoprotein (LDL) and reported in mg/dL

  2. Mean changes in weight 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]

    Weight will be measured on a digital scale and reported in kilograms (kg)

  3. Mean changes in insulin resistance 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]

    Insulin resistance will be assessed using serum glucose and insulin to calculate homeostatic model of insulin resistance (HOMA-IR) [fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5]

  4. Mean changes in abdominal circumference 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]

    Abdominal circumference will be measured on bare skin at the minimal waistline with a tension-sensitive, non-elastic tape and reported in centimeters (cm)

  5. Mean changes in high sensitivity C-reactive protein (hs-CRP) 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]

    hsCRP will assessed using serum and reported in mg/L

  6. Mean changes in Gamma-Glutamyl-Transferase (GGT) 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]

    GGT will assessed using serum and reported in U/L

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 70 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Toshia Myers Santa Rosa California United States 95404

Sponsors and Collaborators

  • TrueNorth Health Foundation

Investigators

  • Principal Investigator: Toshia R Myers, PhD, Director

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Toshia Myers, Director, TrueNorth Health Foundation
ClinicalTrials.gov Identifier:
NCT04514146
Other Study ID Numbers:
  • TNHF2020-2VAT
First Posted:
Aug 14, 2020
Last Update Posted:
Oct 6, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Toshia Myers, Director, TrueNorth Health Foundation
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2021