Swansea University
Swansea, West Glamorgan, SA2 8PP, United Kingdom
NCT Number: NCT05591573
The study will test whether the consumption of a low versus a high glycemic index pre-bed drink influences sleep architecture, memory consolidation, nocturnal glucose metabolism, and mood.
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Notify Me18 year–35 year
Male
Interventional
Not applicable
Swansea, West Glamorgan, SA2 8PP, United Kingdom
Few studies have examined the impact of meal composition on sleep. Most research has focused on carbohydrate intake, although reports are sporadic and confounded by the manipulation of other macronutrients. Nonetheless, the pattern of results appears to depend on the nature of the sleep variable under investigation e.g., latency, duration, or efficiency. The study will determine whether manipulating the glycemic index of a pre-bed drink influences sleep architecture, procedural and declarative memory consolidation, nocturnal glucose metabolism, and mood.
Participants will stay in the sleep laboratory for three nights, each night separated by one week (visit 1, 2, and 3). The first night is an acclimatisation night. The same procedure will be followed on all three nights, as described below.
On the morning of each visit, a continuous glucose monitor will be set up and worn until 8pm the following evening. Participants will be asked to return to the sleep laboratory at 7pm, having fasted for five hours, and asked to consume a standardised evening meal. Several mood questionnaires will be completed throughout the evening and a polysomnography will be set up. Two memory tasks will be administered at approximately 10pm. Immediately after this, participants will consume either water (night 1), or a low glycemic index or high glycemic index drink (night 2 or 3). Participants will retire to bed at approximately 11pm and woken up between 6.30am - 8am, depending on personal preference.
In the morning, the memory tasks will be administered again, as well as two mood questionnaires. Participants will be asked to wear a Pro-Diary watch throughout the day, which measures mood and hunger. At 8pm, both the continuous glucose monitor and Pro-diary watch will be collected from the participant.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fruit flavoured drink with low glycemic index sugar (300 ml)
Fruit flavoured drink with high glycemic index sugar (300 ml)
Time frame: Bedtime (approx. 11.00pm) to wake time (approx 7.30am)
Onset of sleep from the time the lights are turned off.
Time frame: Bedtime (approx. 11.00pm) to wake time (approx 7.30am)
The total number of hours of sleep.
Time frame: Bedtime (approx. 11.00pm) to wake time (approx 7.30am)
Hours of wake time after three epochs of sleep have occurred.
Time frame: Bedtime (approx. 11.00pm) to wake time (approx 7.30am)
Total sleep time divided by the time from lights out until awakening in the morning.
Time frame: Bedtime (approx. 11.00pm) to wake time (approx 7.30am)
Time spent in each sleep stage.
Time frame: Bedtime (approx. 11.00pm) to wake time (approx 7.30am)
Number of arousals throughout the night.
Time frame: Administered 10 - 20 minutes after waking up in the morning,
Subjective assessment of sleep quality. Scores range from 0 to 30. Higher scores indicate poorer sleep quality.
Time frame: 25 hours during night 2 and night 3 (weeks 2 and 3)
The 2h and 3h incremental area under the curve (iAUC) will be used to assess glycemic response to the pre-bed drink. The mean amplitude of glycemic excursion (MAGE) will be assessed as an indicator for glycemic variability during the night and for 25 hours.
Time frame: Completed at 10pm, and between 6.30 - 8am the following morning, on night 2 and night 3 (week 2 and 3).
The change in performance from the learning phase to the recall phase.
Time frame: Completed at 10pm, and between 6.30 - 8am the following morning, on night 2 and night 3 (week 2 and 3).
The number of content words (nouns, adjectives, and verbs) correctly recalled.
Time frame: Administered at 8pm on the evening after night 2 and night 3 (week 2 and 3).
Subjective assessment of daytime sleepiness. Scores range from 0 - 24. Higher scores indicate more daytime sleepiness.
Time frame: Completed five times throughout the evening and twice in the morning (immediately after waking up and 20-30 minutes later) on night 2 and night 3 (week 2 and 3). .
Scores range from 0 - 100. Higher scores indicate stronger feelings.
Time frame: Prompted from 9.30am - 5.30pm after night 2 and night 3 (week 2 and 3).
Pro-diary watch
Time frame: Night 2 and night 3 (week 2 and 3).
Time spent in each sleep stage.
Swansea University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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