Clinical trial NCT05953285: The Impact of Sleep Restriction on Gastric Emptying, Appetite and Energy Intake
Official title: The Impact of Sleep Restriction on Gastric Emptying, Appetite and Energy Intake in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Sleep restriction
Gastrointestinal function
Appetite regulation
Gut hormones
Hedonic appetite
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study is a within-subjects, randomized crossover experimental design.
Primary purpose: PREVENTION

Brief summary: This study aims to examine if partial sleep deprivation results in alterations blood markers and subjective markers of homeostatic, and hedonic appetite, as well as provide initial data as to the impact of sleep restriction on gastric emptying.

Detailed description: The proposed study will take the form of a within-subjects, randomised crossover experimental design. The data will be quantitative. The study will take place for total of approximately 5 weeks / 37 days (+ up to 6 weeks depending on their schedule: Minimum duration = 5 weeks (37 days), Maximum duration = Approximately 11 weeks (79 days).

Following a telephone screening, participants will be provided with a pre-paid envelope containing secondary screening questionnaires in the form of paper documents. Either by drop-off or post to at their place of residence or place of work. The secondary screening documents are detailed under Inclusion / Exclusion criteria and Secondary screening sub-headings. Participants will then return the filled-out inclusion / exclusion documentation if they still desire to take part in the study, either through the pre-paid envelope, or to be picked up by the research team. A member of the research team will then analyse the participants responses and inform them of their eligibility to take part, via email. Following this, participants will be invited to the lab.

Upon entering the lab, participants will be provided with an informed consent form to sign. Following this, demographic information will be collected (Approximately 45 minutes to an hour): This is detailed under the preliminary data collection sub-heading. During this visit, the participant will also be provided with an actigraphy device in order to measure habitual sleep times for one week. Following this, participants will continue to be wear the actigraphy device for a subsequent week, with participants maintaining habitual duration of time in bed, although with (Potentially) altered bedtime, with 7am wake times, in order to standardise participants to 7am wake times and eliminate any erratic sleeping behaviours leading up to the first experimental trial. Participants will also be provided with a food intake and activity diary. The following visits will take the form of experimental trials (Habitual vs 50% habitual sleep): In which the variables of interest will be tested. Namely, blood markers of appetite, self-reported appetite scores, food preference and craving, heart rate variability, gastric emptying, and energy intake. Participants will not be compensated for taking part in the study but will be reimbursed the cost of travelling to and from the lab.

Eligibility criteria: Inclusion

1. Healthy (As assessed with medical screening questionnaire)
2. Self-reported habitual bedtimes between 7 to 9 hours (As assessed with the Pittsburgh sleep quality index)
3. Between the ages of 18 to 45

Exclusion

1. Participants will also be excluded from participation if they are pregnant.
2. Current smokers
3. Excessive alcohol (\>2 drinks per day)
4. Excessive caffeine (\>300mg per day)
5. Musculoskeletal injury.
6. Shift work during the past 4 weeks
7. Travel across more than one time zones during the past 4 weeks.
8. An indication of having a depressed mood (As assessed by a score on the Centre for Epidemiologic Studies of Depression scale above 16).
9. Moderately or highly physically active, as determined by the International Physical Activity Questionnaire (IPAQ) short form.
10. Excessive daytime sleepiness as measured by the Epworth Sleepiness Scale (Score \> 10) (ESS) (Hart et al., 2015).
11. Participants will also be considered ineligible if they achieve a score indicative of narcolepsy or chronic insomnia, as assessed through the Pittsburgh Sleep Quality Index \[PSQI\] (Score \> 5) (Hart et al., 2015).
12. Participants must achieve a score \< 50 on the Food Craving Questionnaire-Trait-reduced (FCQ-T-r), which has been shown to discriminated between individuals with and without "food addiction" with high sensitivity (85%) and specificity (93%) (Meule et al., 2014).

Primary outcomes:
measure: Fasting blood markers: Dopamine, Endocannabinoids, Ghrelin, Leptin, Orexin, and Peptide tyrosine tyrosine
timeFrame: Comparisons in fasting blood markers will be made between sleep restricted vs control conditions. A fasted blood sample will be collected during the 5 minute period from 08:10 - 08:15
measure: Difference in postprandial blood markers: Dopamine, Endocannabinoids, Ghrelin, Leptin, Orexin, and Peptide tyrosine tyrosine for a breakfast meal
timeFrame: Following the ingestion of a breakfast meal at 08:15, blood will be drawn every 15 minutes until 1 hour postprandially, then every 30 minutes until 3 hours postprandially.
measure: Difference in postprandial blood markers: Dopamine, Endocannabinoids, Ghrelin, Leptin, Orexin, and Peptide tyrosine tyrosine for a lunch-time meal
timeFrame: Following the ingestion of a lunchtime meal at 12:30, blood will be drawn every 15 minutes until 1 hour postprandially, then every 30 minutes until 3 hours postprandially.
measure: Difference in postprandial blood markers: Dopamine, Endocannabinoids, Ghrelin, Leptin, Orexin, and Peptide tyrosine tyrosine for an evening meal
timeFrame: Following the ingestion of an evening meal meal at 16:45, blood will be drawn every 15 minutes until 1 hour postprandially, then every 30 minutes until 3 hours postprandially.
measure: Difference in diurnal blood markers: Dopamine, Endocannabinoids, Ghrelin, Leptin, Orexin, and Peptide tyrosine tyrosine
timeFrame: Blood samples will be drawn at 08:10, and continue to be drawn at regular intervals of 15, 30 and 60 minutes until 20:00.
Secondary outcomes:
measure: Difference in gastric emptying of an evening meal
timeFrame: Every 15 mins for 2 hours following test meal. Comparisons will be made between sleep restricted and control conditions.
measure: Difference in subjective feelings of appetite in a fasted state
timeFrame: Ratings of fasting subjective appetite will be collected during the 5 minute period elapsed from 08:10 - 08:15. Comparisons will be made between sleep restricted vs control conditions.
measure: Difference in subjective feelings of appetite following a breakfast meal
timeFrame: Every 30 minutes up until 3 hours postprandially, following the ingestion of the test meal at 08:15.
measure: Difference in subjective feelings of appetite following a lunch time meal
timeFrame: Every 30 minutes up until 3 hours postprandially, following the ingestion of the test meal at 12:30.
measure: Difference in subjective feelings of appetite following an evening meal
timeFrame: Every 30 minutes up until 3 hours postprandially, following the ingestion of the test meal at 16:45
measure: Difference in subjective feelings of appetite throughout the diurnal period.
timeFrame: Every 30 mins throughout the 11.45 hour testing period.
measure: Implicit liking and wanting at mid-day: The Leeds food preference questionnaire (LFPQ)
timeFrame: The LFPQ will be given to participants during the 15 minute period elapsed from 12:15 -12:30, immediately prior to being served the lunchtime meal.
measure: Implicit liking and wanting in the evening: The Leeds food preference questionnaire (LFPQ)
timeFrame: The LFPQ will be given to participants during the 15 minute period elapsed from 19:45 - 20:00, immediately prior leaving the lab.
measure: Heart rate variability (HRV)
timeFrame: Heart rate variability (HRV) data will be gathered from 21:00 on day 2 until 20:00 on day 3, using a polar H9 chest strap heart rate monitor. Differences will be examined between control (Habitual sleep) and intervention (50% of hab
measure: Fasting food craving: The Food Cravings Questionnaire-State (FCQ-S)
timeFrame: Scores will be gathered in a fasted state during the 5 minute period elapsed from 08:10 - 08:15. Comparisons will be made between sleep restricted vs control conditions.
measure: Postprandial food craving, breakfast: The Food Cravings Questionnaire-State (FCQ-S)
timeFrame: Scores will be gathered during the 5 minute period elapsed from 08:30 - 08:35 following the breakfast meal. Comparisons will be made between sleep restricted vs control conditions.
measure: Preprandial food craving, lunch: The Food Cravings Questionnaire-State (FCQ-S)
timeFrame: Scores will be gathered during the 5 minute period elapsed from 12:25 - 12:30, prior to the lunchtime meal. Comparisons will be made between sleep restricted vs control conditions.
measure: Postprandial food craving, lunch: The Food Cravings Questionnaire-State (FCQ-S)
timeFrame: Scores will be gathered during the 5 minute period elapsed from 12:45 - 12:50, following the lunchtime meal. Comparisons will be made between sleep restricted vs control conditions.
measure: Preprandial food craving, evening meal: The Food Cravings Questionnaire-State (FCQ-S)
timeFrame: Scores will be gathered during the 5 minute period elapsed from 16:40 - 16:45, prior to the evening meal. Comparisons will be made between sleep restricted vs control conditions.
measure: Postprandial food craving, evening meal: The Food Cravings Questionnaire-State (FCQ-S)
timeFrame: Scores will be gathered during the 5 minute period elapsed from 17:00 - 17:05 following the evening meal. Comparisons will be made between sleep restricted vs control conditions.
measure: Night-time food craving, end of trial: The Food Cravings Questionnaire-State (FCQ-S)
timeFrame: Scores will be gathered during the 5 minute period elapsed from 20:00 - 20:05 immediately prior to leaving the lab. Comparisons will be made between sleep restricted vs control conditions.
Other outcomes:
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Northumbria university
state: Tyne And Wear
Study officials:
References: