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NCT04090840 · ClinicalTrials.gov registry record · NA
Lifestyle Intervention Feasibility for Arrhythmia and Symptoms With Intermittent Fasting (LIFE AS IF)
A NA study, sponsored by University of Chicago.
- Completed
- Registry status
- NA
- Development phase
- 51
- Enrollment target
NCT04090840 is a NA study that has completed, run by University of Chicago. The registered enrollment target is 51 participants.
The verdict
NCT04090840, a NA study, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- NA
- Development phase
- 51 participants
- Enrollment target
Study 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, m
Interventions
- BEHAVIORAL Intermittent Fasting
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2019-08-01 |
| Est. Completion | 2021-01-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04090840
The ClinicalTrials.gov registry entry for NCT04090840 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Intermittent Fasting is the first listed.
NCT04090840 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04090840 about?
NCT04090840 is a clinical study titled "Lifestyle Intervention Feasibility for Arrhythmia and Symptoms With Intermittent Fasting (LIFE AS IF)". 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 st...
What is the current status of trial NCT04090840?
This trial is currently completed. It is a NA study. The enrollment target is 51 participants. The study started on 2019-08-01. Estimated completion is 2021-01-30.
What interventions are being tested in trial NCT04090840?
The interventions under investigation include: Intermittent Fasting (BEHAVIORAL).
Who is sponsoring clinical trial NCT04090840?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
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