Sleep ArchitectureNCT05591573
The Impact of Glycemic Index on Sleep and Memory Consolidation
A study testing Low glycemic index drink and High glycemic index drink in people with Sleep Architecture and Cognitive Function, run by Swansea University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Architecture, Cognitive Function, Mood
- What is being tested?
- Low glycemic index drink and High glycemic index drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Dec 2022to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Swansea University
Swansea, West Glamorgan, SA2 8PP
About this study
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.
Read the detailed 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.
- Conditions
- Sleep Architecture, Cognitive Function, Mood, Glucose Metabolism
- Being tested
- Low glycemic index drink, High glycemic index drink
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low glycemic index drinkDietary supplement
Fruit flavoured drink with low glycemic index sugar (300 ml)
High glycemic index drinkDietary supplement
Fruit flavoured drink with high glycemic index sugar (300 ml)
| Study group | Role | What they receive |
|---|---|---|
| Low glycemic index drink | Experimental | Fruit drink containing low glycemic index sugar. Receives: Dietary Supplement: Low glycemic index drink |
| High glycemic index drink | Experimental | Fruit drink containing high glycemic index sugar. Receives: Dietary Supplement: High glycemic index drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep onset latency (polysomnography)
Onset of sleep from the time the lights are turned off.
Measured: Bedtime (approx. 11.00pm) to wake time (approx 7.30am)
Total sleep time (polysomnography)
The total number of hours of sleep.
Measured: 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.
Measured: 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.
Measured: Bedtime (approx. 11.00pm) to wake time (approx 7.30am)
Sleep stages (polysomnography)
Time spent in each sleep stage.
Measured: Bedtime (approx. 11.00pm) to wake time (approx 7.30am)
Arousal index (polysomnography)
Number of arousals throughout the night.
Measured: 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.
Measured: Administered 10 - 20 minutes after waking up in the morning,
Secondary outcomes (7)
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.
Measured: 25 hours during night 2 and night 3 (weeks 2 and 3)
Finger tapping task (procedural memory)
The change in performance from the learning phase to the recall phase.
Measured: 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)
The number of content words (nouns, adjectives, and verbs) correctly recalled.
Measured: Completed at 10pm, and between 6.30 - 8am the following morning, on night 2 and night 3 (week 2 and 3).
Epworth Sleepiness Scale
Subjective assessment of daytime sleepiness. Scores range from 0 - 24. Higher scores indicate more daytime sleepiness.
Measured: Administered at 8pm on the evening after night 2 and night 3 (week 2 and 3).
Mood and hunger
Scores range from 0 - 100. Higher scores indicate stronger feelings.
Measured: 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). .
Mood
Pro-diary watch
Measured: Prompted from 9.30am - 5.30pm after night 2 and night 3 (week 2 and 3).
Actigraphy
Time spent in each sleep stage.
Measured: Night 2 and night 3 (week 2 and 3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start31 Dec 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep ArchitectureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In a randomized, double-blind, and counterbalanced order (AB/BA), participants will receive either a high glycemic index or low glycemic index pre-bed drink. After a 1-week washout period, participants will consume the alternate drink.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swansea University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Hayley Young, Swansea University
- Investigators
- Hayley Young, Study director, Swansea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591573
- Sponsor's protocol ID
- SSSU
- Status last verified
- Mar 2024
- First submitted
- 15 Jul 2022
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39854800
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Glycemic Index on Sleep and Memory Consolidation
- ClinicalTrials.gov ID
- NCT05591573
- Acronym / sponsor ID
- SSSU
- Conditions
- Sleep Architecture, Cognitive Function, Mood, Glucose Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Swansea UniversityUniversity, hospital or other
- Study start
- 31 Dec 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In a randomized, double-blind, and counterbalanced order (AB/BA), participants will receive either a high glycemic index or low glycemic index pre-bed drink. After a 1-week washout period, participants will consume the alternate drink.
| Arm | Type | Receives |
|---|---|---|
| Low glycemic index drink | Experimental | Dietary Supplement: Low glycemic index drinkFruit drink containing low glycemic index sugar. |
| High glycemic index drink | Experimental | Dietary Supplement: High glycemic index drinkFruit drink containing high glycemic index sugar. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low glycemic index drinkFruit flavoured drink with low glycemic index sugar (300 ml) | Dietary supplement | Low glycemic index drink |
| High glycemic index drinkFruit flavoured drink with high glycemic index sugar (300 ml) | Dietary supplement | High glycemic index drink |
Primary outcome
Sleep onset latency (polysomnography)
Time frame: Bedtime (approx. 11.00pm) to wake time (approx 7.30am)
Onset of sleep from the time the lights are turned off.
Total sleep time (polysomnography)
Time frame: Bedtime (approx. 11.00pm) to wake time (approx 7.30am)
The total number of hours of sleep.
Wake after sleep onset (polysomnography)
Time frame: Bedtime (approx. 11.00pm) to wake time (approx 7.30am)
Hours of wake time after three epochs of sleep have occurred.
Sleep efficiency (polysomnography)
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.
Sleep stages (polysomnography)
Time frame: Bedtime (approx. 11.00pm) to wake time (approx 7.30am)
Time spent in each sleep stage.
Arousal index (polysomnography)
Time frame: Bedtime (approx. 11.00pm) to wake time (approx 7.30am)
Number of arousals throughout the night.
Leeds Sleep Evaluation Questionnaire
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.
7 secondary outcomes
Glucose response (continuous glucose monitor)
Time frame: 25 hours during night 2 and night 3 (weeks 2 and 3)
Finger tapping task (procedural memory)
Time frame: 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)
Time frame: Completed at 10pm, and between 6.30 - 8am the following morning, on night 2 and night 3 (week 2 and 3).
Epworth Sleepiness Scale
Time frame: Administered at 8pm on the evening after night 2 and night 3 (week 2 and 3).
Mood and hunger
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). .
Mood
Time frame: Prompted from 9.30am - 5.30pm after night 2 and night 3 (week 2 and 3).
Actigraphy
Time frame: Night 2 and night 3 (week 2 and 3).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Derived from this study: PubMed 39854800Gaylor 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hayley Young study director
Swansea University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low glycemic index drink and High glycemic index drink in people with Sleep Architecture and Cognitive Function, run by Swansea University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep onset latency (polysomnography) (time frame: Bedtime (approx. 11.00pm) to wake time (approx 7.30am)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05591573, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.