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Completed

NCT Number: NCT04507516

Fasting for Brain and Heart Health (FBHH)

This pilot study is designed to investigate the effect of water-only fasting and refeeding on the homeostatic model of insulin resistance (HOMA-IR), a measure of insulin resistance.

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Key information

Conditions

Insulin Resistance Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

TrueNorth Health Center

Santa Rosa, California, 95404, United States

About this study

Ischemic stroke is a leading cause of death and a major public health burden. Data suggests that insulin resistance is a potential risk factor for cardiovascular disease, including ischemic stroke, and that dietary and lifestyle intervention can reduce insulin resistance as well as these disease risks. Nonetheless, current intervention strategies have done little to reduce overall stroke incidence. Therefore, an intervention, such as prolonged medically supervised water-only fasting, might be an effective strategy to both reduce insulin resistance and encourage dietary and lifestyle changes that reduce incidence of stroke.

This pilot study is designed to investigate the effect of water-only fasting and refeeding on the homeostatic model of insulin resistance (HOMA-IR), a measure of insulin resistance. Additionally, the study will assess if markers of cardiovascular health and inflammation change before and after water-only fasting. Water-only fasting participants will be recruited from patients who voluntarily elect to water-only fast for 10 or more consecutive days. Clinical variables and blood will be collected at baseline, every 7th day during fasting and refeeding, and the final day of fasting and refeeding.

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 <12 6mg/dL and/or hemoglobin A1c <7%
  • Body Mass Index (BMI) >25 kg/m2
  • Elect and qualify for a water-only fast of at least 10 consecutive days
  • Provide informed consent

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 90 days

Treatment and study plan

Water-only Fasting

Other

Water-only fasting for at least 10 days followed by 5 days of refeed.

Primary outcomes

  1. 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

    Insulin resistance 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]

Secondary outcomes

  1. 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

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

  2. 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

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

  3. Changes in resting systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline

    Time frame: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast

    SBP and DBP measured using digital blood pressure device and reported in mmHg

  4. 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

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

  5. Changes in high sensitivity C-reactive protein (hsCRP) from baseline

    Time frame: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast

    hsCRP assessed using serum and reported in mg/L

Sponsors and collaborators

Lead sponsor

TrueNorth Health Foundation

Other

Registry information

Official study title

A Pilot Study on the Effects of Medically Supervised, Water-Only Fasting and Refeeding on Cardiometabolic Risk

Acronym: FBHH

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 11, 2020
Registry last updated
Aug 11, 2020

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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