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

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ClinicalTrials.gov Identifier: NCT04514146
Recruitment Status : Enrolling by invitation
First Posted : August 14, 2020
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Toshia Myers, TrueNorth Health Foundation

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
Visceral Obesity Insulin Resistance 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.

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Study Type : Observational
Estimated 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 : August 15, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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

  2. 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)

  3. 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]

  4. 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)

  5. 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

  6. 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


Biospecimen Retention:   Samples Without DNA
sera and plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Overweight and obese, non-diabetic participants chosen from voluntary patients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04514146


Locations
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United States, California
Toshia Myers
Santa Rosa, California, United States, 95404
Sponsors and Collaborators
TrueNorth Health Foundation
Investigators
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Principal Investigator: Toshia R Myers, PhD Director
Publications:

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Responsible Party: Toshia Myers, Director, TrueNorth Health Foundation
ClinicalTrials.gov Identifier: NCT04514146    
Other Study ID Numbers: TNHF2020-2VAT
First Posted: August 14, 2020    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Toshia Myers, TrueNorth Health Foundation:
water-only fasting
HOMA-IR
insulin resistance
visceral adipose tissue
Additional relevant MeSH terms:
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Insulin Resistance
Obesity, Abdominal
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Obesity
Overnutrition
Nutrition Disorders