Clinical trial NCT04507516: Fasting for Brain and Heart Health (FBHH)
Official title: A Pilot Study on the Effects of Medically Supervised, Water-Only Fasting and Refeeding on Cardiometabolic Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insulin Resistance
Lead sponsor: TrueNorth Health Foundation
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Overweight and obese, non-diabetic participants recruited from voluntary patients.

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.

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.

Eligibility 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

Primary outcomes:
measure: Changes in insulin resistance from baseline
timeFrame: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
Secondary outcomes:
measure: Changes in lipid profile from baseline
timeFrame: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
measure: Changes in weight from baseline
timeFrame: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
measure: Changes in resting systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline
timeFrame: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
measure: Changes in abdominal circumference from baseline
timeFrame: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
measure: Changes in high sensitivity C-reactive protein (hsCRP) from baseline
timeFrame: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
Other outcomes:
Locations:
city: Santa Rosa
country: United States
facility: TrueNorth Health Center
state: California
Study officials:
affiliation: Director
name: Toshia R Myers, PhD
role: PRINCIPAL_INVESTIGATOR
References: