The primary objective of this study is to investigate the effect of either the consumption of 1 or 3 small meals compared to no meal during the night shift on alertness levels. Secondary objectives of this study are to investigate the effect of…
ID
Source
Brief title
Condition
- Other condition
- Appetite and general nutritional disorders
Synonym
Health condition
cognitief functioneren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters will be objective alertness measured as total number
of lapses and reciprocal reaction time.
Secondary outcome
Secondary study parameters will be subjective alertness levels,
gastrointestinal complaints and glucose levels.
Background summary
Night shift workers have a 30 percent higher risk of making (medical) errors or
having accidents than day shift workers. This is mainly the result of shift
work-related fatigue which is related to lower alertness levels. Alertness
levels are at lowest between 2:00h and 6:00h in the early morning, and eating a
large meal impairs alertness levels even further. Not eating, or eating one or
more small meals during the night shift could improve alertness levels.
Study objective
The primary objective of this study is to investigate the effect of either the
consumption of 1 or 3 small meals compared to no meal during the night shift on
alertness levels.
Secondary objectives of this study are to investigate the effect of either the
consumption of 1 or 3 small meals compared to no meal during the night shift on
gastrointestinal complaints and glucose levels and to investigate the effect of
low glycaemic loaded meal(s) compared to high glycaemic loaded meal(s) during
the night shift on alertness levels, gastrointestinal complaints and glucose
levels.
Study design
2-armed randomized cross-over intervention study, where each study arm consist
of three intervention periods.
Intervention
During two of the three intervention periods, nurses will receive either 1
small meal or 3 small meals during the night shift. During one of these two
intervention periods the meals consist of carbohydrates high in glycaemic load
and during the other intervention period the meals consist of carbohydrates low
in glycaemic load. During a third intervention period participants both study
arms will receive no meal during the night shift as a control.
Study burden and risks
Participation in the study will not bring any risks. Also patient safety will
not be jeopardized. The burden for participants will be kept as low as
possible. The placement of the continuous glucose monitor (CGM), though quite
non-obtrusive, can be considered as a burden for the participants. The placing
of each piece of equipment will be done by experienced researchers and will be
secured by well-practiced measures to minimize issues the participant may
encounter. The calibration of the CGM may be considered a burden due to the
finger prick that is required four times a day by a glucose meter. Participants
will have to invest approximately 5 hours in the study, therefore time
investment could be a potential burden. Also following the dietary regimen can
be considered as a burden. As a personal benefit, participants get more insight
in their eating patterns, alertness levels and glucose metabolism. The results
of this study will provide information about the effects of meal frequency on
the nurses* alertness levels, gastrointestinal complaints and glucose
metabolism. With the results of this study we want to optimize dietary
guidelines for shift workers in order to improve the fitness and wellbeing of
shift workers and to reduce the risk of making (medical) errors or having
accidents.
Stippeneng 4
Wageningen 6708WE
NL
Stippeneng 4
Wageningen 6708WE
NL
Listed location countries
Age
Inclusion criteria
Female
Working the night shifts for at least 3 months
At least 18 years old and not older than 67 years at time of recruitment
Willingness to adhere to a nutrition protocol
Exclusion criteria
Diagnosed with Diabetes Mellitus type 1 or 2
Diagnosed with hypoglycaemia
Do follow a specific diet (e.g. Atkins, ketogenic diet)
Current participation in other medical research
Reported unexplained weight loss or weight gain of > 5 kg in the month prior to
pre-study screening
Smoking during the night shift
Being lactose-intolerant.
Being fructose-intolerant.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
Other | Nederlands Trial Register |
CCMO | NL72634.081.20 |
OMON | NL-OMON25574 |