The Impact of Sleep Restriction on Gastric Emptying, Appetite and Energy Intake

NCT05953285 | Unknown DMC

• 1 other identifier: NorthumbiaU
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Sleep restriction; Gastrointestinal function; Appetite regulation; Gut hormones; Hedonic appetite

Outcome Measures

Primary Outcomes (5)

• Fasting blood markers: Dopamine, Endocannabinoids, Ghrelin, Leptin, Orexin, and Peptide tyrosine tyrosine

  A fasting blood sample will be collected in EDTA and Heparin vacutainers in order to assess blood markers of appetite, gastrointestinal function and motivation to feed.

  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

• Difference in postprandial blood markers: Dopamine, Endocannabinoids, Ghrelin, Leptin, Orexin, and Peptide tyrosine tyrosine for a breakfast meal

  8 blood sample will be collected in EDTA and Heparin vacutainers in order to assess blood markers of appetite, gastrointestinal function and motivation to feed. Comparisons will be made between sleep restricted vs control conditions for the area under curve (AUC) for the 3 hour postprandial period.

  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.

• Difference in postprandial blood markers: Dopamine, Endocannabinoids, Ghrelin, Leptin, Orexin, and Peptide tyrosine tyrosine for a lunch-time meal

  8 blood sample will be collected in EDTA and Heparin vacutainers in order to assess blood markers of appetite, gastrointestinal function and motivation to feed. Comparisons will be made between sleep restricted vs control conditions for the area under curve (AUC) for the 3 hour postprandial period.

  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.

• Difference in postprandial blood markers: Dopamine, Endocannabinoids, Ghrelin, Leptin, Orexin, and Peptide tyrosine tyrosine for an evening meal

  8 blood sample will be collected in EDTA and Heparin vacutainers in order to assess blood markers of appetite, gastrointestinal function and motivation to feed. Comparisons will be made between sleep restricted vs control conditions for the area under curve (AUC) for the 3 hour postprandial period.

  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.

• Difference in diurnal blood markers: Dopamine, Endocannabinoids, Ghrelin, Leptin, Orexin, and Peptide tyrosine tyrosine

  27 blood samples will be collected in EDTA and Heparin vacutainers throughout the day, in order to assess blood markers of appetite, gastrointestinal function and motivation to feed. Comparisons will be made between the area under curve (AUC) for the entire diurnal period (11.45 hours), for the sleep restricted vs control conditions.

  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 (16)

• Difference in gastric emptying of an evening meal

  Every 15 mins for 2 hours following test meal. Comparisons will be made between sleep restricted and control conditions.

• Difference in subjective feelings of appetite in a fasted state

  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.

• Difference in subjective feelings of appetite following a breakfast meal

  Every 30 minutes up until 3 hours postprandially, following the ingestion of the test meal at 08:15.

• Difference in subjective feelings of appetite following a lunch time meal

  Every 30 minutes up until 3 hours postprandially, following the ingestion of the test meal at 12:30.

• Difference in subjective feelings of appetite following an evening meal

  Every 30 minutes up until 3 hours postprandially, following the ingestion of the test meal at 16:45

Study Arms (2)

Restricted sleep on blood markers and subjective markers of homeostatic, and hedonic appetite

EXPERIMENTAL

The proposed study will take the form of a within-subjects, randomized 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).

Other: Sleep restriction

Restricted sleep on gastric emptying

EXPERIMENTAL

The proposed study will take the form of a within-subjects, randomized 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).

Other: Sleep restriction

Interventions

Sleep restriction OTHER

The proposed study will take the form of a within-subjects, randomized crossover experimental design. The data will be quantitative.

Restricted sleep on blood markers and subjective markers of homeostatic, and hedonic appetite; Restricted sleep on gastric emptying

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Participants will also be excluded from participation if they are pregnant.
• Current smokers
• Excessive alcohol (\>2 drinks per day)
• Excessive caffeine (\>300mg per day)
• Musculoskeletal injury.
• Shift work during the past 4 weeks
• Travel across more than one time zones during the past 4 weeks.
• An indication of having a depressed mood (As assessed by a score on the Centre for Epidemiologic Studies of Depression scale above 16).
• Moderately or highly physically active, as determined by the International Physical Activity Questionnaire (IPAQ) short form.
• Excessive daytime sleepiness as measured by the Epworth Sleepiness Scale (Score \> 10) (ESS) (Hart et al., 2015).
• 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).
• 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).

Sponsors & Collaborators

• Northumbria University: lead

Study Sites (1)

Northumbria university

Newcastle upon Tyne, Tyne and Wear, NE3 1YF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Victoria McIver, PhD

CONTACT

+44 (0)191 227 3910; victoria.mciver@northumbria.ac.uk

Ian Walshe, PhD

CONTACT

+44 (0)191 227 3517; ian2.walshe@northumbria.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a within-subjects, randomized crossover experimental design.

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: July 20, 2023
• Study Start: July 15, 2023
• Primary Completion: January 17, 2024
• Study Completion: January 17, 2024
• Last Updated: December 15, 2023

Record last verified: 2023-12

Locations

GB (1)