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Fasting for Brain and Heart Health (FBHH) (FBHH)

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ClinicalTrials.gov Identifier: NCT04507516
Recruitment Status : Completed
First Posted : August 11, 2020
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
TrueNorth Health Foundation

Brief Summary:
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.

Condition or disease Intervention/treatment
Insulin Resistance Other: Water-only Fasting

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study on the Effects of Medically Supervised, Water-Only Fasting and Refeeding on Cardiometabolic Risk
Actual Study Start Date : April 2, 2019
Actual Primary Completion Date : February 10, 2020
Actual Study Completion Date : February 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Group/Cohort Intervention/treatment
Water-only Fasting Cohort
Obese/overweight, non-diabetic patients undergoing elective water-only fasting treatment.
Other: Water-only Fasting
Water-only fasting for at least 10 days followed by 5 days of refeed.




Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
plasma, sera


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 recruited from voluntary patients.
Criteria

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

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): NCT04507516


Locations
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United States, California
TrueNorth Health Center
Santa Rosa, California, United States, 95404
Sponsors and Collaborators
TrueNorth Health Foundation
Investigators
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Principal Investigator: Toshia R Myers, PhD Director
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Responsible Party: TrueNorth Health Foundation
ClinicalTrials.gov Identifier: NCT04507516    
Other Study ID Numbers: TNHF2018-1
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 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
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases