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Health Sciences › Medicine › Cardiology and Cardiovascular Medicine
Effect of intermittent fasting after ST-elevation myocardial infarction on left ventricular function: study protocol of a pilot randomised controlled trial (INTERFAST-MI)
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Paper Summary
Conflicts of Interest
Identified Weaknesses
Rating Explanation
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Paper Summary
Paperzilla title
Can Intermittent Fasting Mend a Broken Heart? A Tiny First Look
This pilot study will examine the effect of an intermittent fasting regime (8/16 hour fast/feed cycle) on left ventricular ejection fraction in patients who recently had a heart attack. The small sample size (n=48) limits the study's power to detect a statistically significant benefit. The lack of blinding and single center design also weaken the study.
Possible Conflicts of Interest
The study is funded by the German Heart Research Foundation. No other conflicts were identified.
Identified Weaknesses
Unblinded, single center study
The study is being conducted at a single center and is not blinded, which introduces biases from patient and physician expectations. Patient reported outcomes in particular are strongly influenced by placebo effects. Blinding, while not possible for the intervention, is possible for outcome assessment.
Small sample size
With 48 participants total, this study is underpowered to identify a statistically significant effect unless the effect is very large.
Surrogate endpoint
While the study is powered for a larger trial, the primary outcome, change in LV systolic function at 4 weeks, may not be the most relevant outcome. The effect of intermittent fasting on more meaningful clinical outcomes is not examined in this pilot study.
Suboptimal Intermittent Fasting Regimen
The choice of an 8 hour time restricted eating window is based on evidence indicating that longer fasts may be more beneficial. However, the evidence for a benefit of time restricted eating is much stronger. Thus the study may not be evaluating the ideal regimen of intermittent fasting.
Rating Explanation
This is a pilot study with a small sample size and several methodological weaknesses including an unblinded, single center design. The outcome is a surrogate marker of heart health, and the effect of the intervention on clinical outcomes has not been determined. However, the study utilizes a sound methodology, and the limitations are appropriate given its status as a pilot study. The results will inform the design of a larger, more robust trial.
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Topic Hierarchy
File Information
Original Title:
Effect of intermittent fasting after ST-elevation myocardial infarction on left ventricular function: study protocol of a pilot randomised controlled trial (INTERFAST-MI)
File Name:
e050067.full.pdf
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File Size:
0.32 MB
Uploaded:
August 09, 2025 at 02:40 PM
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