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

October 4, 2021 updated by: Toshia Myers, TrueNorth Health Foundation

A Pilot Study on the Effects of Water-only Fasting and Refeeding on Body Composition and Insulin Resistance

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Rosa, California, United States, 95404
        • Toshia Myers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Overweight and obese, non-diabetic participants chosen from voluntary patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean changes in visceral adipose tissue from baseline
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean changes in total fat and lean mass and bone mineral content (BMC) from baseline
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean changes in lipid profile from baseline
Time Frame: 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
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
Mean changes in weight from baseline
Time Frame: 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)
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
Mean changes in insulin resistance from baseline
Time Frame: 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]
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
Mean changes in abdominal circumference from baseline
Time Frame: 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)
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
Mean changes in high sensitivity C-reactive protein (hs-CRP) from baseline
Time Frame: 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
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
Mean changes in Gamma-Glutamyl-Transferase (GGT) from baseline
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TrueNorth Health Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2020

Primary Completion (Actual)

October 1, 2021

Study Completion (Actual)

October 1, 2021

Study Registration Dates

First Submitted

August 12, 2020

First Submitted That Met QC Criteria

August 12, 2020

First Posted (Actual)

August 14, 2020

Study Record Updates

Last Update Posted (Actual)

October 6, 2021

Last Update Submitted That Met QC Criteria

October 4, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNHF2020-2VAT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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