Sleep RestrictionNCT05524701
Short-term Sleep Restriction on Taste Preference and Perception
A study testing Sleep Restriction and Normal Sleep in people with Sleep Restriction and Normal Sleep, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
The study aims is to investigate the effects of sleep restriction on sweet and fat taste perception and preference in both fasted and fed states. This is a randomised crossover trial with sleep restriction (4 hours per night for 2 nights) and normal sleep (at least 8 hours sleep for 2 nights) conditions, with a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Restriction, Normal Sleep
- What is being tested?
- Sleep Restriction and Normal Sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2022to 28 Feb 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and above
- Self Reported sleep of >7 hours a night
Who cannot join
- Dairy allergy
- Presence of any serious medical conditions which might influence sleep i.e cardiovascular diseases, diabetes, cancer, respiratory disease, other than mild asthma)
- History of bariatric surgery
- Taking any kind of medication which might affect regular sleep
- Taking any type of medication which might affect appetite
- Participating in any kind of dietary and/or weight loss programs
Show all 11Show fewer
- Taking antidepressants
- Substance or alcohol abuse
- Shift work
- Currently having to wake up at night to care for another person
- Suffering from and/or receiving treatment for mental health conditions or sleep apnoea.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Glasgow
Glasgow, G12 8QQ
Jason Gill, PhD, 0141 330 ext. 2916, jason.gill@glasgow.ac.uk
Ayan Merchant, MSc, 0141 330 ext. 2671, a.merchant.1@research.gla.ac.uk
About this study
Official title: The Effect of Short-term Sleep Restriction on Sweet and Fat Taste Preference and Perception.
The study aims is to investigate the effects of sleep restriction on sweet and fat taste perception and preference in both fasted and fed states. This is a randomised crossover trial with sleep restriction (4 hours per night for 2 nights) and normal sleep (at least 8 hours sleep for 2 nights) conditions, with a four-week washout period between conditions.
Read the detailed description
Sleep restriction has been found to dysregulate appetite regulation, leading to an increased food intake, particularly of foods high in sugar and fat. It is unclear why sleep restriction leads to increased fat and sugar intake, but emerging evidence suggests that taste preference and perception may be influenced by the lack of sleep.
Sleep restriction leads to increased preference for sucrose. However it is unclear whether sleep restriction also alters perception of sweetness, or whether it affects preference or perception of dietary fat. It is also unclear, whether any changes in sweet and fat preference and perception due to sleep restriction differ between the fasted and fed states.
This study is a randomised crossover trial where each participant will undertake two conditions (sleep restriction and normal sleep) in a randomised order. In the sleep restriction condition, participants will be asked to restrict their sleep duration to a maximum of four hours per night for two nights, and in the normal sleep group they will be asked to sleep for at least eight hours per night for two nights. There will a 4-week wash-out period between conditions. After each condition (2 nights of normal sleep or 2 nights of sleep restriction), particpants asked to arrive in a fasted state for the assessments. They will initially undertake the Control of Eating Questionnaire (COEQ) and the Leeds Food Preference Questionnaire (LFPQ). Participants will then undertake the sweet and fat taste perception and preference tests (described below). Following this, all participants will be provided with a standardized breakfast meal, and 60 minutes later, the LFPQ and taste preference and perception tests will be repeated in fed state.
- Conditions
- Sleep Restriction, Normal Sleep
- Being tested
- Sleep Restriction and Normal Sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Restriction and Normal SleepBehavioural
The intervention will consist of either sleep restriction (4 hours per night, 3 am to 7 am) or normal sleep (8 hours per night 11 pm to 7 am) for a duration of two nights.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Restriction Condition | Experimental | Participants will be asked to restrict their sleep duration to a maximum of four hours per night (3 am to 7 am) for the two nights prior to the measurement day. Receives: Behavioral: Sleep Restriction and Normal Sleep |
| Normal Sleep Condition | Experimental | Participants will be asked to sleep for at least eight hours per night (11 pm to 7 am) for two nights prior to the measurement day. Receives: Behavioral: Sleep Restriction and Normal Sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sweet Taste Preference
Preference for sweetness will be assessed by providing participants with 5ml volumes of 5 sucrose solutions with concentrations 3%, 6%, 12%, 24% and 36% in random order. Preference for sweetness will be assessed by asking participants to rate the pleasantness of the solution on a VAS with anchors of 'not at all pleasant' and 'extremely pleasant'.
To determine the preferred optimal sweetness, participants will be presented with pairs of 5 sucrose solutions and asked which solution they prefer. This will continue until the participants consistently choose a preference for a solution twice a row. A maximum of 10 trials will be conducted to assess preference. This assessment will be done fasted and fed state.
Measured: 0-4 weeks
Sweet Taste Perception
Perception of sweetness will be assessed by providing participants with 5ml volumes of 5 sucrose solutions with concentrations 3%, 6%, 12%, 24% and 36% in random order. The perception of sweetness will be measured via visual analogue scale (VAS) to rate the sweetness of the solution with anchors of 'not at all sweet' and 'extremely sweet'.
Measured: 0-4 weeks
Fat Taste Preference
Preference for fat taste will be assessed by providing participants with 5ml volumes 5 solutions with combinations with concentrations 3%, 6%, 12%, 24% and 36% fat (comprising skimmed milk and double cream mixes of different proportions) in random order. Preference for fat taste will be assessed by asking participants to rate pleasantness of the solution on a VAS with anchors of 'not at all' and 'extremely'.
To determine the preferred optimal fat taste, participants will be presented with 5 pairs of milk and cream mix solutions and asked which solution they prefer. This will continue until the participants consistently choose a preference for one solution twice in a row. A maximum of 10 trials will be conducted to assess preference. This assessment will be done fasted and fed state.
Measured: 0-4 weeks
Fat Taste Perception
Perception and preference for fat will be assessed by providing participants with 5ml volumes 5 solutions with combinations with concentrations 3%, 6%, 12%, 24% and 36% fat (comprising skimmed milk and double cream mixes of different proportions) in random order. The perception of fat will be measured via a visual analogue scale (VAS) to rate the creaminess of solution with anchors of 'not at all' and 'extremely'.
Measured: 0-4 weeks
Secondary outcomes (7)
Food preference - explicit liking
Changes in explicit liking measured by the Leeds Food Preference Questionnaire
This assessment will be conducted in a fasted and post-prandial state.
Scale range:
Changes in explicit liking measured by the Leeds Food Preference Questionnaire.
Scoring:
The minimum score for VAS scale is 0 and maximum is 100. Scores are recorded and converted in to mean scores for high fat, low fat, sweet or savoury food types and different fat-taste combinations.
Measured: 0-4 weeks
Food preference - explicit wanting
Changes in explicit wanting measured by the Leeds Food Preference Questionnaire
This assessment will be conducted in a fasted and post-prandial state.
Scale range:
Changes in explicit wanting measured by the Leeds Food Preference Questionnaire.
Scoring:
The minimum score for VAS scale is 0 and maximum is 100. Scores are recorded and converted in to mean scores for high fat, low fat, sweet or savoury food types and different fat-taste combinations.
Measured: 0-4 weeks
Food reward - implicit wanting
Changes in implicit wanting and food choice measured by the Leeds Food Preference Questionnaire
This assessment will be conducted in a fasted and post-prandial state.
Scale range:
The computerized asessment where participants are presented with two images and they choose which they like.
Scoring:
Reaction time for each answer is recorded and converted in to mean scores for high fat, low fat, sweet or savoury food types and different fat-taste combinations.
Measured: 0-4 weeks
Control of Eating Questionnaire - Craving control
Changes in craving control measured by the Control of Eating Questionnaire
This assessment will be conducted in a fasted and post-prandial state.
Scale range:
The asessment includes a 20 items with a 10 point scale ranging from "not at all" to "extremely" and 1 item with free text answer.
Scoring:
The minimum score for VAS scale is 0 and maximum is 100. The sum of items were calculated and divided by number of items in the subscale.
Measured: 0-4 weeks
Control of Eating Questionnaire - Craving for sweet
Changes in craving for sweet measured by the Control of Eating Questionnaire
This assessment will be conducted in a fasted and post-prandial state.
Scale range:
The asessment includes a 20 items with a 10 point scale ranging from "not at all" to "extremely" and 1 item with free text answer.
Scoring:
The minimum score for VAS scale is 0 and maximum is 100. The sum of items were calculated and divided by number of items in the subscale.
Measured: 0-4 weeks
Control of Eating Questionnaire - Craving for savoury
Changes in craving for savoury measured by the Control of Eating Questionnaire
This assessment will be conducted in a fasted and post-prandial state.
Scale range:
The asessment includes a 20 items with a 10 point scale ranging from "not at all" to "extremely" and 1 item with free text answer.
Scoring:
The minimum score for VAS scale is 0 and maximum is 100. The sum of items were calculated and divided by number of items in the subscale.
Measured: 0-4 weeks
Control of Eating Questionnaire - Positive mood
Changes in positive mood measured by the Control of Eating Questionnaire
This assessment will be conducted in a fasted and post-prandial state.
Scale range:
The asessment includes a 20 items with a 10 point scale ranging from "not at all" to "extremely" and 1 item with free text answer.
Scoring:
The minimum score for VAS scale is 0 and maximum is 100. The sum of items were calculated and divided by number of items in the subscale. Higher the score indicates higher cravings.
Measured: 0-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start1 Sep 2022 (estimated)
- Primary completion28 Feb 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep RestrictionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomised crossover trial with one group undergoing two conditions- a sleep restriction condition and a normal sleep condition.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Jason Gill, University of Glasgow
- Investigators
- Jason Gill, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524701
- Sponsor's protocol ID
- 200210063
- Status last verified
- Aug 2022
- First submitted
- 29 Aug 2022
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Short-term Sleep Restriction on Sweet and Fat Taste Preference and Perception.
- ClinicalTrials.gov ID
- NCT05524701
- Acronym / sponsor ID
- 200210063
- Conditions
- Sleep Restriction, Normal Sleep
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 1 Sep 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 aims is to investigate the effects of sleep restriction on sweet and fat taste perception and preference in both fasted and fed states. This is a randomised crossover trial with sleep restriction (4 hours per night for 2 nights) and normal sleep (at least 8 hours sleep for 2 nights) conditions, with a four-week washout period between conditions.
Detailed description
Sleep restriction has been found to dysregulate appetite regulation, leading to an increased food intake, particularly of foods high in sugar and fat. It is unclear why sleep restriction leads to increased fat and sugar intake, but emerging evidence suggests that taste preference and perception may be influenced by the lack of sleep.
Sleep restriction leads to increased preference for sucrose. However it is unclear whether sleep restriction also alters perception of sweetness, or whether it affects preference or perception of dietary fat. It is also unclear, whether any changes in sweet and fat preference and perception due to sleep restriction differ between the fasted and fed states.
This study is a randomised crossover trial where each participant will undertake two conditions (sleep restriction and normal sleep) in a randomised order. In the sleep restriction condition, participants will be asked to restrict their sleep duration to a maximum of four hours per night for two nights, and in the normal sleep group they will be asked to sleep for at least eight hours per night for two nights. There will a 4-week wash-out period between conditions. After each condition (2 nights of normal sleep or 2 nights of sleep restriction), particpants asked to arrive in a fasted state for the assessments. They will initially undertake the Control of Eating Questionnaire (COEQ) and the Leeds Food Preference Questionnaire (LFPQ). Participants will then undertake the sweet and fat taste perception and preference tests (described below). Following this, all participants will be provided with a standardized breakfast meal, and 60 minutes later, the LFPQ and taste preference and perception tests will be repeated in fed state.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomised crossover trial with one group undergoing two conditions- a sleep restriction condition and a normal sleep condition.
| Arm | Type | Receives |
|---|---|---|
| Sleep Restriction Condition | Experimental | Behavioral: Sleep Restriction and Normal SleepParticipants will be asked to restrict their sleep duration to a maximum of four hours per night (3 am to 7 am) for the two nights prior to the measurement day. |
| Normal Sleep Condition | Experimental | Behavioral: Sleep Restriction and Normal SleepParticipants will be asked to sleep for at least eight hours per night (11 pm to 7 am) for two nights prior to the measurement day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years and above
- Self Reported sleep of >7 hours a night
Key exclusion criteria (11 listed)
- Dairy allergy
- Presence of any serious medical conditions which might influence sleep i.e cardiovascular diseases, diabetes, cancer, respiratory disease, other than mild asthma)
- History of bariatric surgery
- Taking any kind of medication which might affect regular sleep
- Taking any type of medication which might affect appetite
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 |
|---|---|---|
| Sleep Restriction and Normal SleepThe intervention will consist of either sleep restriction (4 hours per night, 3 am to 7 am) or normal sleep (8 hours per night 11 pm to 7 am) for a duration of two nights. | Behavioural | Normal Sleep Condition, Sleep Restriction Condition |
Primary outcome
Sweet Taste Preference
Time frame: 0-4 weeks
Preference for sweetness will be assessed by providing participants with 5ml volumes of 5 sucrose solutions with concentrations 3%, 6%, 12%, 24% and 36% in random order. Preference for sweetness will be assessed by asking participants to rate the pleasantness of the solution on a VAS with anchors of 'not at all pleasant' and 'extremely pleasant'. To determine the preferred optimal sweetness, participants will be presented with pairs of 5 sucrose solutions and asked which solution they prefer. This will continue until the participants consistently choose a preference for a solution twice a row. A maximum of 10 trials will be conducted to assess preference. This assessment will be done fasted and fed state.
Sweet Taste Perception
Time frame: 0-4 weeks
Perception of sweetness will be assessed by providing participants with 5ml volumes of 5 sucrose solutions with concentrations 3%, 6%, 12%, 24% and 36% in random order. The perception of sweetness will be measured via visual analogue scale (VAS) to rate the sweetness of the solution with anchors of 'not at all sweet' and 'extremely sweet'.
Fat Taste Preference
Time frame: 0-4 weeks
Preference for fat taste will be assessed by providing participants with 5ml volumes 5 solutions with combinations with concentrations 3%, 6%, 12%, 24% and 36% fat (comprising skimmed milk and double cream mixes of different proportions) in random order. Preference for fat taste will be assessed by asking participants to rate pleasantness of the solution on a VAS with anchors of 'not at all' and 'extremely'. To determine the preferred optimal fat taste, participants will be presented with 5 pairs of milk and cream mix solutions and asked which solution they prefer. This will continue until the participants consistently choose a preference for one solution twice in a row. A maximum of 10 trials will be conducted to assess preference. This assessment will be done fasted and fed state.
Fat Taste Perception
Time frame: 0-4 weeks
Perception and preference for fat will be assessed by providing participants with 5ml volumes 5 solutions with combinations with concentrations 3%, 6%, 12%, 24% and 36% fat (comprising skimmed milk and double cream mixes of different proportions) in random order. The perception of fat will be measured via a visual analogue scale (VAS) to rate the creaminess of solution with anchors of 'not at all' and 'extremely'.
7 secondary outcomes
Food preference - explicit liking
Time frame: 0-4 weeks
Food preference - explicit wanting
Time frame: 0-4 weeks
Food reward - implicit wanting
Time frame: 0-4 weeks
Control of Eating Questionnaire - Craving control
Time frame: 0-4 weeks
Control of Eating Questionnaire - Craving for sweet
Time frame: 0-4 weeks
Control of Eating Questionnaire - Craving for savoury
Time frame: 0-4 weeks
Control of Eating Questionnaire - Positive mood
Time frame: 0-4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
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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.
Jason Gill, PhD principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Restriction and Normal Sleep in people with Sleep Restriction and Normal Sleep, run by University of Glasgow 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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 1 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jason Gill, PhD (141 330 2916 ext. +44, jason.gill@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sweet Taste Preference (time frame: 0-4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2022.