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

Primary Purpose

Obesity, Morbid Obesity, Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intermittent Fasting
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, fasting, diet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of ChicagoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intermittent Fasting

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Body Mass Index
calculated from height and weight measured in clinic
Waist Circumference
measured by research specialist at umbilicus
Blood Pressure
measured in clinic by nursing staff
Quality of Life Assessment
SF36 Questionnaire to be filled out by patient
Hemoglobin a1c
Blood test in patients with diabetes mellitus

Full Information

First Posted
September 11, 2019
Last Updated
September 18, 2019
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT04090840
Brief Title
Lifestyle Intervention Feasibility for Arrhythmia and Symptoms With Intermittent Fasting (LIFE AS IF)
Acronym
LIFE AS IF
Official Title
Lifestyle Intervention Feasibility for Arrhythmia and Symptoms With Intermittent Fasting (LIFE AS IF)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid Obesity, Diabetes Mellitus, Type 2, Atrial Fibrillation
Keywords
obesity, fasting, diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective observation study of lifestyle intervention with intermittent fasting (time-restricted eating) of 16 hours every day.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intermittent Fasting
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intermittent Fasting
Intervention Description
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 Outcome Measure Information:
Title
Weight loss
Description
Patients will be weighed weekly for the first month and than have weight checks in clinic monthly
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Body Mass Index
Description
calculated from height and weight measured in clinic
Time Frame
Monthly until 6 months
Title
Waist Circumference
Description
measured by research specialist at umbilicus
Time Frame
Monthly until 6 months
Title
Blood Pressure
Description
measured in clinic by nursing staff
Time Frame
Monthly until 6 months
Title
Quality of Life Assessment
Description
SF36 Questionnaire to be filled out by patient
Time Frame
6 months
Title
Hemoglobin a1c
Description
Blood test in patients with diabetes mellitus
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tiffany Hart
Phone
7737020535
Email
thart@medicine.bsd.uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roderick Tung, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiffany Hart
Phone
773-702-0535
Email
thart@medicine.bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Roderick Tung, MD
Phone
773-834-0455
Email
rtung1@medicine.bsd.uchicago.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24993615
Citation
Barnosky AR, Hoddy KK, Unterman TG, Varady KA. Intermittent fasting vs daily calorie restriction for type 2 diabetes prevention: a review of human findings. Transl Res. 2014 Oct;164(4):302-11. doi: 10.1016/j.trsl.2014.05.013. Epub 2014 Jun 12.
Results Reference
background
PubMed Identifier
27737674
Citation
Moro T, Tinsley G, Bianco A, Marcolin G, Pacelli QF, Battaglia G, Palma A, Gentil P, Neri M, Paoli A. Effects of eight weeks of time-restricted feeding (16/8) on basal metabolism, maximal strength, body composition, inflammation, and cardiovascular risk factors in resistance-trained males. J Transl Med. 2016 Oct 13;14(1):290. doi: 10.1186/s12967-016-1044-0.
Results Reference
background
PubMed Identifier
26135345
Citation
Horne BD, Muhlestein JB, Anderson JL. Health effects of intermittent fasting: hormesis or harm? A systematic review. Am J Clin Nutr. 2015 Aug;102(2):464-70. doi: 10.3945/ajcn.115.109553. Epub 2015 Jul 1.
Results Reference
background
PubMed Identifier
24240932
Citation
Abed HS, Wittert GA, Leong DP, Shirazi MG, Bahrami B, Middeldorp ME, Lorimer MF, Lau DH, Antic NA, Brooks AG, Abhayaratna WP, Kalman JM, Sanders P. Effect of weight reduction and cardiometabolic risk factor management on symptom burden and severity in patients with atrial fibrillation: a randomized clinical trial. JAMA. 2013 Nov 20;310(19):2050-60. doi: 10.1001/jama.2013.280521.
Results Reference
background
PubMed Identifier
30887044
Citation
Middeldorp ME, Pathak RK, Lau DH, Sanders P. PREVEntion and regReSsive Effect of weight-loss and risk factor modification on Atrial Fibrillation: the REVERSE-AF study-Authors' reply. Europace. 2019 Jun 1;21(6):990-991. doi: 10.1093/europace/euz050. No abstract available.
Results Reference
background
PubMed Identifier
30571593
Citation
Yaeger A, Cash NR, Parham T, Frankel DS, Deo R, Schaller RD, Santangeli P, Nazarian S, Supple GE, Arkles J, Riley MP, Garcia FC, Lin D, Epstein AE, Callans DJ, Marchlinski FE, Kolansky DM, Mora JI, Amaro A, Schwab R, Pack A, Dixit S. A Nurse-Led Limited Risk Factor Modification Program to Address Obesity and Obstructive Sleep Apnea in Atrial Fibrillation Patients. J Am Heart Assoc. 2018 Dec 4;7(23):e010414. doi: 10.1161/JAHA.118.010414.
Results Reference
background
PubMed Identifier
30813495
Citation
Fernando HA, Zibellini J, Harris RA, Seimon RV, Sainsbury A. Effect of Ramadan Fasting on Weight and Body Composition in Healthy Non-Athlete Adults: A Systematic Review and Meta-Analysis. Nutrients. 2019 Feb 24;11(2):478. doi: 10.3390/nu11020478.
Results Reference
background
PubMed Identifier
28715993
Citation
Patterson RE, Sears DD. Metabolic Effects of Intermittent Fasting. Annu Rev Nutr. 2017 Aug 21;37:371-393. doi: 10.1146/annurev-nutr-071816-064634. Epub 2017 Jul 17.
Results Reference
background
PubMed Identifier
24097021
Citation
Hussin NM, Shahar S, Teng NI, Ngah WZ, Das SK. Efficacy of fasting and calorie restriction (FCR) on mood and depression among ageing men. J Nutr Health Aging. 2013;17(8):674-80. doi: 10.1007/s12603-013-0344-9.
Results Reference
background
PubMed Identifier
21781980
Citation
Teng NI, Shahar S, Manaf ZA, Das SK, Taha CS, Ngah WZ. Efficacy of fasting calorie restriction on quality of life among aging men. Physiol Behav. 2011 Oct 24;104(5):1059-64. doi: 10.1016/j.physbeh.2011.07.007. Epub 2011 Jul 18.
Results Reference
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Lifestyle Intervention Feasibility for Arrhythmia and Symptoms With Intermittent Fasting (LIFE AS IF)

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