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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04507516
Other study ID # TNHF2018-1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2, 2019
Est. completion date February 10, 2020

Study information

Verified date August 2020
Source TrueNorth Health Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date February 10, 2020
Est. primary completion date February 10, 2020
Accepts healthy volunteers
Gender All
Age group 40 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States TrueNorth Health Center Santa Rosa California

Sponsors (1)

Lead Sponsor Collaborator
TrueNorth Health Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in insulin resistance from baseline 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] Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
Secondary Changes in lipid profile from baseline Lipid profile assessed using serum to measure cholesterol, triglycerides, high-density lipoprotein (HDL), and low-density 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
Secondary Changes in weight from baseline Weight 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
Secondary Changes in resting systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline SBP and DBP measured using digital blood pressure device and reported in mmHg Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
Secondary Changes in abdominal circumference from baseline Abdominal circumference 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
Secondary Changes in high sensitivity C-reactive protein (hsCRP) from baseline hsCRP 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
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