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Completed

NCT Number: NCT04514146

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

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

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Key information

Conditions

Visceral Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Toshia Myers

Santa Rosa, California, 95404, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Water-only Fasting

Other

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

TrueNorth Health Foundation

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 14, 2020
Registry last updated
Oct 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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