The Impact of Glycemic Index on Sleep and Memory Consolidation
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2022
CompletedFirst Posted
Study publicly available on registry
October 24, 2022
CompletedStudy Start
First participant enrolled
December 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedMarch 12, 2024
March 1, 2024
4 months
July 15, 2022
March 8, 2024
Conditions
Outcome Measures
Primary Outcomes (7)
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)
Total sleep time (polysomnography)
The total number of hours of sleep.
Bedtime (approx. 11.00pm) to wake time (approx 7.30am)
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)
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)
Sleep stages (polysomnography)
Time spent in each sleep stage.
Bedtime (approx. 11.00pm) to wake time (approx 7.30am)
Arousal index (polysomnography)
Number of arousals throughout the night.
Bedtime (approx. 11.00pm) to wake time (approx 7.30am)
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 Outcomes (7)
Glucose response (continuous glucose monitor)
25 hours during night 2 and night 3 (weeks 2 and 3)
Finger tapping task (procedural memory)
Completed at 10pm, and between 6.30 - 8am the following morning, on night 2 and night 3 (week 2 and 3).
Story recall task (declarative memory)
Completed at 10pm, and between 6.30 - 8am the following morning, on night 2 and night 3 (week 2 and 3).
Epworth Sleepiness Scale
Administered at 8pm on the evening after night 2 and night 3 (week 2 and 3).
Mood and hunger
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). .
- +2 more secondary outcomes
Study Arms (2)
Low glycemic index drink
EXPERIMENTALFruit drink containing low glycemic index sugar.
High glycemic index drink
EXPERIMENTALFruit drink containing high glycemic index sugar.
Interventions
Fruit flavoured drink with low glycemic index sugar (300 ml)
Fruit flavoured drink with high glycemic index sugar (300 ml)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Swansea University
Swansea, West Glamorgan, SA2 8PP, United Kingdom
Related Publications (1)
Gaylor CM, Brennan A, Blagrove M, Tulip C, Bloxham A, Williams S, Tucker R, Benton D, Young HA. Low and high glycemic index drinks differentially affect sleep polysomnography and memory consolidation: A randomized controlled trial. Nutr Res. 2025 Feb;134:49-59. doi: 10.1016/j.nutres.2024.11.012. Epub 2024 Dec 4.
PMID: 39854800DERIVED
Study Officials
- STUDY DIRECTOR
Hayley Young
Swansea University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- To ensure blinding of participants and researchers, a randomisation list will be produced using Statistical Package for the Social Sciences (SPSS) software by an employee of Swansea University, who is not actively involved in the study. Blinding will be maintained by the use of encoded beverages to ensure participants, researchers, and the data analysers are unaware of the intervention. The blind will be broken only after statistical analysis of the data is complete.
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 15, 2022
First Posted
October 24, 2022
Study Start
December 31, 2022
Primary Completion
April 30, 2023
Study Completion
April 30, 2023
Last Updated
March 12, 2024
Record last verified: 2024-03