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ObesityLIFE AS IFNCT04090840

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

A study testing Intermittent Fasting in people with Obesity and Morbid Obesity, run by University of Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Morbid Obesity, Diabetes Mellitus, Type 2
What is being tested?
Intermittent Fasting
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteUnited States
Study dates
1 Aug 2019to 30 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The University of Chicago

    Chicago, Illinois, 60637

Other trials in United States

About this study

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.

Read more

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.

Being tested
Intermittent Fasting
Keywords
obesity, fasting, diet
Medical subject headings
Obesity, Obesity, Morbid, Diabetes Mellitus, Type 2, Atrial Fibrillation, Fasting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intermittent FastingBehavioural

    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.

Study groups in NCT04090840
Study groupRoleWhat they receive
Intermittent FastingExperimentalPatients 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.
Receives: Behavioral: Intermittent Fasting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight loss

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

    Measured: 6 months

Secondary outcomes (5)

  1. Body Mass Index

    calculated from height and weight measured in clinic

    Measured: Monthly until 6 months

  2. Waist Circumference

    measured by research specialist at umbilicus

    Measured: Monthly until 6 months

  3. Blood Pressure

    measured in clinic by nursing staff

    Measured: Monthly until 6 months

  4. Quality of Life Assessment

    SF36 Questionnaire to be filled out by patient

    Measured: 6 months

  5. Hemoglobin a1c

    Blood test in patients with diabetes mellitus

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2019
  2. Study start1 Aug 2019
  3. Primary completion30 Jan 2021
  4. Study completion30 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective observation study of lifestyle intervention with intermittent fasting (time-restricted eating) of 16 hours every day.
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04090840
Sponsor's protocol ID
IRB19-0879
Acronym
LIFE AS IF
Status last verified
May 2024
First submitted
11 Sep 2019
Last updated
6 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24993615

  • 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.

    PubMed 27737674

  • 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.

    PubMed 26135345

  • 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.

    PubMed 24240932

  • 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.

    PubMed 30887044

  • 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.

    PubMed 30571593

  • 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.

    PubMed 30813495

  • 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.

    PubMed 28715993

  • 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.

    PubMed 24097021

  • 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.

    PubMed 21781980

Questions about this trial

What is this clinical trial studying?

A study testing Intermittent Fasting in people with Obesity and Morbid Obesity, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight loss (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04090840, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.

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