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

Sponsor
University of Chicago (Other)
Overall Status
Unknown status
CT.gov ID
NCT04090840
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Intermittent Fasting
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
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.Prospective observation study of lifestyle intervention with intermittent fasting (time-restricted eating) of 16 hours every day.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Lifestyle Intervention Feasibility for Arrhythmia and Symptoms With Intermittent Fasting (LIFE AS IF)
Actual Study Start Date :
Aug 1, 2019
Anticipated Primary Completion Date :
Aug 1, 2020
Anticipated Study Completion Date :
Aug 1, 2021

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Weight loss [6 months]

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

Secondary Outcome Measures

  1. Body Mass Index [Monthly until 6 months]

    calculated from height and weight measured in clinic

  2. Waist Circumference [Monthly until 6 months]

    measured by research specialist at umbilicus

  3. Blood Pressure [Monthly until 6 months]

    measured in clinic by nursing staff

  4. Quality of Life Assessment [6 months]

    SF36 Questionnaire to be filled out by patient

  5. Hemoglobin a1c [6 months]

    Blood test in patients with diabetes mellitus

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Chicago Chicago Illinois United States 60637

Sponsors and Collaborators

  • University of Chicago

Investigators

  • Principal Investigator: Roderick Tung, MD, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Chicago
ClinicalTrials.gov Identifier:
NCT04090840
Other Study ID Numbers:
  • IRB19-0879
First Posted:
Sep 16, 2019
Last Update Posted:
Sep 20, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Chicago
obesity
fasting
diet
Additional relevant MeSH terms:
Atrial Fibrillation
Obesity
Diabetes Mellitus, Type 2
Obesity, Morbid

Study Results

No Results Posted as of Sep 20, 2019