Lifestyle Intervention Feasibility for Arrhythmia and Symptoms With Intermittent Fasting (LIFE AS IF) (LIFE AS IF)
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|ClinicalTrials.gov Identifier: NCT04090840|
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : September 20, 2019
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.
To prospectively assess compliance to prescribed intermittent fasting, measured by adherence and change in weight at 6 months.
|Condition or disease||Intervention/treatment||Phase|
|Obesity Morbid Obesity Diabetes Mellitus, Type 2 Atrial Fibrillation||Behavioral: Intermittent Fasting||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective observation study of lifestyle intervention with intermittent fasting (time-restricted eating) of 16 hours every day.|
|Masking:||None (Open Label)|
|Official Title:||Lifestyle Intervention Feasibility for Arrhythmia and Symptoms With Intermittent Fasting (LIFE AS IF)|
|Actual Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2021|
Experimental: Intermittent Fasting
Patients will follow intermittent fasting for 16 hours with time restricted eating during an 8 hour window. The subjects are also advised to minimize sugar intake to <15g per serving.
Behavioral: Intermittent Fasting
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.
- Weight loss [ Time Frame: 6 months ]Patients will be weighed weekly for the first month and than have weight checks in clinic monthly
- Body Mass Index [ Time Frame: Monthly until 6 months ]calculated from height and weight measured in clinic
- Waist Circumference [ Time Frame: Monthly until 6 months ]measured by research specialist at umbilicus
- Blood Pressure [ Time Frame: Monthly until 6 months ]measured in clinic by nursing staff
- Quality of Life Assessment [ Time Frame: 6 months ]SF36 Questionnaire to be filled out by patient
- Hemoglobin a1c [ Time Frame: 6 months ]Blood test in patients with diabetes mellitus
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): NCT04090840
|Contact: Tiffany Hartfirstname.lastname@example.org|
|Principal Investigator:||Roderick Tung, MD||University of Chicago|