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OpenTrials
Completed

NCT Number: NCT04090840

Lifestyle Intervention Feasibility for Arrhythmia and Symptoms With Intermittent Fasting (LIFE AS IF)

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18
  • BMI≥ 30
  • Ongoing evaluation and management of cardiac arrhythmias

Exclusion criteria

  • Pregnant or nursing
  • Eating disorder or history of eating disorders (self-report)
  • Diabetic mellitus type 1 or insulin requiring type 2 diabetes

Treatment and study plan

Intermittent fasting

Behavioral

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.

Primary outcomes

  1. Weight loss

    Time frame: 6 months

    Patients will be weighed weekly for the first month and than have weight checks in clinic monthly

Secondary outcomes

  1. Body Mass Index

    Time frame: Monthly until 6 months

    calculated from height and weight measured in clinic

  2. Waist Circumference

    Time frame: Monthly until 6 months

    measured by research specialist at umbilicus

  3. Blood Pressure

    Time frame: Monthly until 6 months

    measured in clinic by nursing staff

  4. Quality of Life Assessment

    Time frame: 6 months

    SF36 Questionnaire to be filled out by patient

  5. Hemoglobin a1c

    Time frame: 6 months

    Blood test in patients with diabetes mellitus

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Acronym: LIFE AS IF

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 16, 2019
Registry last updated
May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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