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A 14-day randomized clinical trial assessing effects of caffeinated coffee consumption in a population of 100 adult patients, CRAVE offers what could be the most definitive insight yet into the effects of coffee consumption on overall health.
Full results of the CRAVE randomized trial could put an end to the debate around the safety of caffeine and coffee intake on cardiovascular health.1
Results of the trial, which randomized 100 patients and fitted each with a continuously recording electrocardiogram device, a wrist-worn accelerometer, and a continuous glucose monitor, suggest consumption of caffeinated coffee was not associated with a statistically significant increase in premature atrial contractions, but was associated with improvements in total daily steps, nightly sleep, and serum glucose levels.1
“Among 100 healthy adults, the consumption of caffeinated coffee did not result in more daily premature atrial contractions than the avoidance of caffeine,” wrote investigators.1 “Our results further suggest that both assignment to daily coffee consumption and greater-than-normal coffee consumption were associated with more recorded daily steps taken, fewer minutes of sleep per night, and potentially more daily premature ventricular contractions among persons who consumed more than one coffee drink per day.”
Clinicians were offered their first glimpse into the CRAVE trial at the American Heart Association 2021 annual scientific sessions by Gregory Marcus, MD, of the University of San Francisco.2 Per trial protocol, patients were randomized to consume or avoid caffeine during 2-days periods, with assignments made by means of daily text messages sent over a 14-day period. Adherence to the assignment was monitored through Zio patch button-presses to timestamp every time coffee was consumed and through daily surveys assessing coffee consumption on the previous day.1
The primary outcome of interest was the number of premature atrial contractions per 24-hour period. Secondary outcomes of interest included were daily number of premature ventricular contractions, daily step counts, daily minutes of sleep, mean daily serum glucose levels, and interactions between each outcome and caffeine-metabolism–related genetic variants.1
The overall patient cohort had a mean age of 39 (SD, 13) years, 51% were female, the median BMI was 24 (IQR, 22-26) kg/m2, 51% identified as non-Hispanic White, and 34% identified as Asian. When examining usual coffee consumption, 11% reported consuming less than 1 cup of coffee per month and 54% reported consuming at least 1 cup per day, with 25% consuming 2 cups or more daily.1
Upon analysis, 58 daily premature atrial contractions among the group consuming caffeinated coffee as compared with 53 such events among the group abstaining from consumption (Rate ratio [RR], 1.09 [95% confidence interval [CI], 0.98 to 1.0]; P=.10). Analysis of secondary outcome of interest revealed consumption of caffeinated coffee was associated with greater daily premature ventricular contractions (154 vs 102; RR, 1.51 [95% CI, 1.18 to 1.94]), increased daily step count (10,646 vs 9665; mean difference, 1058 [95% CI, 441 to 1675]), fewer daily minutes of sleep (397 vs 432; mean difference, 36 [95% CI, 25 to 47]), and lower serum glucose levels (95 mg/dL vs 96 mg/dL; mean difference, -0.41 [95% CI, -5.42 to 4.60]).1
“These findings suggest protean health-related consequences of consuming this common beverage and provide both clinicians and patients with information that may assist in customizing consumption of coffee to appropriately fit with individual health goals,” investigators added.1
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