The University of Chicago
Chicago, Illinois, 60637, United States
NCT Number: NCT04090840
BACKGROUND AND RATIONALE
Two out of three Americans are overweight and obesity is associated with hypertension, sleep apnea, atrial fibrillation. Metabolic syndrome with centripetal obesity is also a precursor to insulin resistance and the development of Type II diabetes mellitus. While multiple strategies for weight reduction are often recommended in physician visits, calculating calories and energy expenditure is often inconvenient and does not promote compliance. Intermittent fasting, or time-restricted eating, is a methods to limit caloric intake by fasting for 16 hours to promote ketosis and suppress insulin secretion. Weight loss and reduction in body fat has been observed with brief periods of intervention as time-restricted eating results in reduction in overall caloric intake. Prospective feasibility studies and randomized comparative trials with intermittent fasting are lacking.
The investigators recommend caloric restriction in all of our patients that suffer from arrhythmias and BMI >30. However, they have not systematically measured compliance and the efficacy of lifestyle interventions. Lifestyle counseling and weight loss has been shown to decrease the progression and burden of symptomatic atrial fibrillation. Intermittent fasting can result in consistent reductions in body fat and weight without specific lifestyle counseling. The aim of the present observation cohort study is to assess the feasibility of recommending intermittent fasting in an arrhythmia clinic with regard to compliance and efficacy.
The investigators hypothesize that compliance and adherence to a 16/8 intermittent fasting regimen will be >25% and result in weight loss, compared to the 6 month trend prior to the intervention. This pilot study will serve as the basis to power the first randomized trial comparing intermittent fasting with other types of dietary counseling for arrhythmia outcomes.
OBJECTIVES
To prospectively assess compliance to prescribed intermittent fasting, measured by adherence and change in weight at 6 months.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Chicago, Illinois, 60637, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time restricted eating for 8 hours per day, with 16 hour fast. During the daily fast, patients are encouraged to drink water, black coffee, or green tea without sugar, cream, milk, or sweeteners.
Time frame: 6 months
Patients will be weighed weekly for the first month and than have weight checks in clinic monthly
Time frame: Monthly until 6 months
calculated from height and weight measured in clinic
Time frame: Monthly until 6 months
measured by research specialist at umbilicus
Time frame: Monthly until 6 months
measured in clinic by nursing staff
Time frame: 6 months
SF36 Questionnaire to be filled out by patient
Time frame: 6 months
Blood test in patients with diabetes mellitus
University of Chicago
Other
Acronym: LIFE AS IF
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