Obesity Clinical Trial
— LIFE AS IFOfficial title:
Lifestyle Intervention Feasibility for Arrhythmia and Symptoms With Intermittent Fasting (LIFE AS IF)
Verified date | May 2024 |
Source | University of Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 51 |
Est. completion date | January 30, 2021 |
Est. primary completion date | January 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | The University of Chicago | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Chicago |
United States,
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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. — View 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. — View Citation
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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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight loss | Patients will be weighed weekly for the first month and than have weight checks in clinic monthly | 6 months | |
Secondary | Body Mass Index | calculated from height and weight measured in clinic | Monthly until 6 months | |
Secondary | Waist Circumference | measured by research specialist at umbilicus | Monthly until 6 months | |
Secondary | Blood Pressure | measured in clinic by nursing staff | Monthly until 6 months | |
Secondary | Quality of Life Assessment | SF36 Questionnaire to be filled out by patient | 6 months | |
Secondary | Hemoglobin a1c | Blood test in patients with diabetes mellitus | 6 months |
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