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

NCT04090840 | Completed

• 1 other identifier: IRB19-0879
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Morbid Obesity; Diabetes Mellitus, Type 2; Atrial Fibrillation

Keywords

obesity; fasting; diet

Outcome Measures

Primary Outcomes (1)

• Weight loss

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

  6 months

Secondary Outcomes (5)

• Body Mass Index

  Monthly until 6 months

• Waist Circumference

  Monthly until 6 months

• Blood Pressure

  Monthly until 6 months

• Quality of Life Assessment

  6 months

• Hemoglobin a1c

  6 months

Study Arms (1)

Intermittent Fasting

EXPERIMENTAL

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

Interventions

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.

Intermittent Fasting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (10)

• 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.

  PMID: 24993615 BACKGROUND

• 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.

  PMID: 27737674 BACKGROUND

• 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.

  PMID: 26135345 BACKGROUND

• 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.

  PMID: 24240932 BACKGROUND

• 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.

  PMID: 30887044 BACKGROUND

• 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.

  PMID: 30571593 BACKGROUND

• 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.

  PMID: 30813495 BACKGROUND

• 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.

  PMID: 28715993 BACKGROUND

• 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.

  PMID: 24097021 BACKGROUND

• 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.

  PMID: 21781980 BACKGROUND

MeSH Terms

Conditions

Obesity; Obesity, Morbid; Diabetes Mellitus, Type 2; Atrial Fibrillation; Fasting

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Feeding Behavior; Behavior

Study Officials

• Roderick Tung, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective observation study of lifestyle intervention with intermittent fasting (time-restricted eating) of 16 hours every day.

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 16, 2019
• Study Start: August 1, 2019
• Primary Completion: January 30, 2021
• Study Completion: January 30, 2021
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)