The Impact of Glycemic Index on Sleep and Memory Consolidation

Cognitive Function Clinical Trial

Official title:

The Impact of Glycemic Index on Sleep and Memory Consolidation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05591573
• Other study ID #: SSSU
• Status: Completed
• Phase: N/A
• Start date: December 31, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: March 2024
• Source: Swansea University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Male (given that the menstrual cycle may influence sleep polysomnography)
• Good health
• Not taking any medication known to effect sleep or metabolism
• Normal sleep duration (i.e. between 6.5 - 9 hours of sleep per night)
• A sleep efficiency score above 80% (Pittsburg Sleep Quality Index)
• Normal sleep schedule (i.e. fall asleep between 10pm and 12pm)
• No difficulty sleeping in new places

Exclusion Criteria:

• Diagnosis of any physical or mental disorder e.g. diabetes, cardiovascular disorders, gastrointestinal disorders, sleep problems, epilepsy, or mood disorders
• Unhealthy weight (BMI over 30)
• Drink more than 300mg of caffeine per day (3 - 4 standard sized 8-oz cups)
• Work nights or shifts
• Smoke/vape
• Regularly drink alcohol (>3 glasses per day)
• Used recreational drugs within the last 6 months
• Take part in >3 hours of vigorous exercise per week
• Any known food allergies or intolerances
• Nocturnal eating or regular consumption of alcohol before bed (assessed by the Meal Pattern Questionnaire)

Related Conditions & MeSH terms

• Cognitive Function
• Glucose Metabolism
• Mood
• Sleep Architecture

Intervention

Dietary Supplement:
• Low glycemic index drink
Fruit flavoured drink with low glycemic index sugar (300 ml)
• High glycemic index drink
Fruit flavoured drink with high glycemic index sugar (300 ml)

Locations

Country	Name	City	State
United Kingdom	Swansea University	Swansea	West Glamorgan

Sponsors (1)

Lead Sponsor	Collaborator
Swansea University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep onset latency (polysomnography)	Onset of sleep from the time the lights are turned off.	Bedtime (approx. 11.00pm) to wake time (approx 7.30am)
Primary	Total sleep time (polysomnography)	The total number of hours of sleep.	Bedtime (approx. 11.00pm) to wake time (approx 7.30am)
Primary	Wake after sleep onset (polysomnography)	Hours of wake time after three epochs of sleep have occurred.	Bedtime (approx. 11.00pm) to wake time (approx 7.30am)
Primary	Sleep efficiency (polysomnography)	Total sleep time divided by the time from lights out until awakening in the morning.	Bedtime (approx. 11.00pm) to wake time (approx 7.30am)
Primary	Sleep stages (polysomnography)	Time spent in each sleep stage.	Bedtime (approx. 11.00pm) to wake time (approx 7.30am)
Primary	Arousal index (polysomnography)	Number of arousals throughout the night.	Bedtime (approx. 11.00pm) to wake time (approx 7.30am)
Primary	Leeds Sleep Evaluation Questionnaire	Subjective assessment of sleep quality. Scores range from 0 to 30. Higher scores indicate poorer sleep quality.	Administered 10 - 20 minutes after waking up in the morning,
Secondary	Glucose response (continuous glucose monitor)	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.	25 hours during night 2 and night 3 (weeks 2 and 3)
Secondary	Finger tapping task (procedural memory)	The change in performance from the learning phase to the recall phase.	Completed at 10pm, and between 6.30 - 8am the following morning, on night 2 and night 3 (week 2 and 3).
Secondary	Story recall task (declarative memory)	The number of content words (nouns, adjectives, and verbs) correctly recalled.	Completed at 10pm, and between 6.30 - 8am the following morning, on night 2 and night 3 (week 2 and 3).
Secondary	Epworth Sleepiness Scale	Subjective assessment of daytime sleepiness. Scores range from 0 - 24. Higher scores indicate more daytime sleepiness.	Administered at 8pm on the evening after night 2 and night 3 (week 2 and 3).
Secondary	Mood and hunger	Scores range from 0 - 100. Higher scores indicate stronger feelings.	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). .
Secondary	Mood	Pro-diary watch	Prompted from 9.30am - 5.30pm after night 2 and night 3 (week 2 and 3).
Secondary	Actigraphy	Time spent in each sleep stage.	Night 2 and night 3 (week 2 and 3).