NCT05591573

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

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 24, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

December 31, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

July 15, 2022

Last Update Submit

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

EXPERIMENTAL

Fruit drink containing low glycemic index sugar.

Dietary Supplement: Low glycemic index drink

High glycemic index drink

EXPERIMENTAL

Fruit drink containing high glycemic index sugar.

Dietary Supplement: High glycemic index drink

Interventions

Low glycemic index drinkDIETARY_SUPPLEMENT

Fruit flavoured drink with low glycemic index sugar (300 ml)

Low glycemic index drink
High glycemic index drinkDIETARY_SUPPLEMENT

Fruit flavoured drink with high glycemic index sugar (300 ml)

High glycemic index drink

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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.

Study Officials

  • Hayley Young

    Swansea University

    STUDY DIRECTOR

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
Model Details: 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.
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

Locations