Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
61 participants
INTERVENTIONAL
2018-10-29
2019-05-11
Brief Summary
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Detailed Description
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Specific objectives are:
1. To assess the effects of macronutrient composition of the test meals on cognitive performance, self-reported sleepiness and fatigue of resident physicians during night-time duty.
2. To compare to no intervention, the effects of providing meals before 22:00 hours, and only providing chewing gum, tea, coffee and water onwards to on-call residents, on cognitive performance, self-reported sleepiness and fatigue of resident physicians during night-time duty.
Conditions
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Study Design
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NA
SINGLE_GROUP
There are two possible combinations and the order will be randomized using a computer-generated random-number sequence. There will be at least a 24-hour wash-out period between study nights to minimize the carry-over effects of the cross-over design as well as learning effects of the computerized cognitive tests.
A: Control- no intervention, B: intervention 1 arm, C: Intervention 2 The order of the blocks will be randomized. block a: A, B, C block b: A, C, B
OTHER
NONE
Study Groups
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Dietary Modification
On the first night of the study, participants can eat and drink as they normally would (no dietary intervention). On second and third nights participants will be provided meals, snacks and drinks with specific macronutrient composition, encouraged to only eat and drink study meals, snacks and drinks, and to avoid eating after 10:00 hours. The composition of the study foods and drinks on nights 2 and 3 will be different.
Dietary Modification
Participants will be provided with meals, snacks and drinks with specific macronutrient compositions and encouraged to only eat and drink study meals, snacks and drinks and to avoid eating after 10:00 hours.
Interventions
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Dietary Modification
Participants will be provided with meals, snacks and drinks with specific macronutrient compositions and encouraged to only eat and drink study meals, snacks and drinks and to avoid eating after 10:00 hours.
Eligibility Criteria
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Inclusion Criteria
* Must be able to eat plant source foods (e.g. soy, nuts, seeds) and animal source foods (e.g. meat, eggs, dairy products)
Exclusion Criteria
* Prior anaphylactic reaction to food
* Strict dietary restrictions (e.g. vegan, gluten free)
21 Years
ALL
Yes
Sponsors
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American Medical Association
OTHER
Stanford University
OTHER
Responsible Party
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Tait Shanafelt
Professor of Medicine
Principal Investigators
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Tait D Shanafelt, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University
Stanford, California, United States
Countries
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References
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Rimmer A. Urgent action is needed to manage doctors' fatigue, says BMA. BMJ. 2018 Jan 9;360:k127. doi: 10.1136/bmj.k127. No abstract available.
Hamidi MS, Boggild MK, Cheung AM. Running on empty: a review of nutrition and physicians' well-being. Postgrad Med J. 2016 Aug;92(1090):478-81. doi: 10.1136/postgradmedj-2016-134131. Epub 2016 May 23.
Gupta CC, Dorrian J, Grant CL, Pajcin M, Coates AM, Kennaway DJ, Wittert GA, Heilbronn LK, Della Vedova CB, Banks S. It's not just what you eat but when: The impact of eating a meal during simulated shift work on driving performance. Chronobiol Int. 2017;34(1):66-77. doi: 10.1080/07420528.2016.1237520. Epub 2016 Oct 13.
Paech GM, Banks S, Pajcin M, Grant C, Johnson K, Kamimori GH, Vedova CB. Caffeine administration at night during extended wakefulness effectively mitigates performance impairment but not subjective assessments of fatigue and sleepiness. Pharmacol Biochem Behav. 2016 Jun;145:27-32. doi: 10.1016/j.pbb.2016.03.011. Epub 2016 Apr 7.
Grant CL, Dorrian J, Coates AM, Pajcin M, Kennaway DJ, Wittert GA, Heilbronn LK, Vedova CD, Gupta CC, Banks S. The impact of meal timing on performance, sleepiness, gastric upset, and hunger during simulated night shift. Ind Health. 2017 Oct 7;55(5):423-436. doi: 10.2486/indhealth.2017-0047. Epub 2017 Jul 25.
Reyner LA, Wells SJ, Mortlock V, Horne JA. 'Post-lunch' sleepiness during prolonged, monotonous driving - effects of meal size. Physiol Behav. 2012 Feb 28;105(4):1088-91. doi: 10.1016/j.physbeh.2011.11.025. Epub 2011 Dec 6.
Attuquayefio T, Stevenson RJ, Oaten MJ, Francis HM. A four-day Western-style dietary intervention causes reductions in hippocampal-dependent learning and memory and interoceptive sensitivity. PLoS One. 2017 Feb 23;12(2):e0172645. doi: 10.1371/journal.pone.0172645. eCollection 2017.
El-Sharkawy AM, Bragg D, Watson P, Neal K, Sahota O, Maughan RJ, Lobo DN. Hydration amongst nurses and doctors on-call (the HANDS on prospective cohort study). Clin Nutr. 2016 Aug;35(4):935-42. doi: 10.1016/j.clnu.2015.07.007. Epub 2015 Jul 16.
Makowski MS, Trockel MT, Menon NK, Wang H, Katznelson L, Shanafelt TD. Performance Nutrition for Physician Trainees Working Overnight Shifts: A Randomized Controlled Trial. Acad Med. 2022 Mar 1;97(3):426-435. doi: 10.1097/ACM.0000000000004509.
Related Links
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Main manuscript: Performance Nutrition for Physician Trainees Working Overnight Shifts: A Randomized Controlled Trial
Other Identifiers
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45690
Identifier Type: -
Identifier Source: org_study_id
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