NCT05524701

Brief 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 four-week washout period between conditions.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

August 29, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

September 1, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

August 29, 2022

Last Update Submit

August 31, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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'.

    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.

    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'.

    0-4 weeks

Secondary Outcomes (7)

  • Food preference - explicit liking

    0-4 weeks

  • Food preference - explicit wanting

    0-4 weeks

  • Food reward - implicit wanting

    0-4 weeks

  • Control of Eating Questionnaire - Craving control

    0-4 weeks

  • Control of Eating Questionnaire - Craving for sweet

    0-4 weeks

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Sleep Restriction and Normal Sleep

Interventions

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.

Normal Sleep ConditionSleep Restriction Condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and above
  • Self Reported sleep of \>7 hours a night

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Glasgow

Glasgow, G12 8QQ, United Kingdom

RECRUITING

Study Officials

  • Jason Gill, PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: A randomised crossover trial with one group undergoing two conditions- a sleep restriction condition and a normal sleep condition.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 29, 2022

First Posted

September 1, 2022

Study Start

September 1, 2022

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

September 1, 2022

Record last verified: 2022-08

Locations