NCT05096585

Brief Summary

Studies in healthy young adults have shown that abnormal and undesirable physiological changes are a result of chronic sleep curtailment, with implications on inflammatory status, blood glucose regulation, circulating free fatty acids, and insulin sensitivity. Epidemiological studies suggest an increase in energy intake with shortened, sleep and this has been associated with weight gain. Interestingly most studies examining sleep restriction do not consider whether the restricted sleep is due to sleep delay or an advanced wake time. This study will investigate the change in physical activity or food intake during a period of sleep restriction. To date only one study has addressed this question but they only examined one study night and followed their subjects for only 24 hr. The objective of the proposed project is to examine the effects of shortened sleep on potential changes in physical activity and energy intake. The investigators hypothesize that after several nights of short sleep that different strategies are employed to remain awake and these strategies will also vary whether bed time was delayed or wake time was advanced. Aim 1: To examine the effects of sleep timing on energy intake and expenditure during periods of sleep restriction

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Aug 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 27, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

1.3 years

First QC Date

October 14, 2021

Last Update Submit

March 9, 2023

Conditions

Keywords

sleep restrictionphysical activitydietary intakeinsulin resistance

Outcome Measures

Primary Outcomes (4)

  • physical activity

    physical activity (percent time in sedentary, light, moderate and vigorous PA)

    24 hours

  • dietary intake

    macronutrient content (percent carbohydrate, fat and protein intake

    24 hours

  • physical activity

    Step count (steps/day)

    24 hours

  • dietary intake

    energy intake (kcals)

    24 hour

Study Arms (3)

normal sleep

PLACEBO COMPARATOR

Subjects will go to sleep at their normal bedtime and normal sleep duration (7-9 hr)

Behavioral: Delayed bedtime sleep restrictionBehavioral: Early wake sleep restriction

delayed bedtime sleep restriction

EXPERIMENTAL

Subjects will go to sleep at 2 hr later than their normal bedtime

Behavioral: Delayed bedtime sleep restrictionBehavioral: Early wake sleep restriction

early waking sleep restriction

EXPERIMENTAL

Subjects will wake up 2 hr earlier than their normal wake time

Behavioral: Delayed bedtime sleep restrictionBehavioral: Early wake sleep restriction

Interventions

bedtime 2 hr later than their normal bedtime

delayed bedtime sleep restrictionearly waking sleep restrictionnormal sleep

wake time 2 hr earlier than their normal wake time

delayed bedtime sleep restrictionearly waking sleep restrictionnormal sleep

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Overweight and obese men and women 21-45 years of age BMI of \<40 kg/m2 normally active (\>5000 steps per day) sleep: 7-9 hours per night

You may not qualify if:

  • type 1 diabetes cardiovascular disease uncontrolled hypertension smoker pregnant recent changes in hormonal birth control night shift workers take regular daytime naps operate heavy equipment Sleep less than 7 hour/night

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Misouri

Columbia, Missouri, 65211, United States

Location

MeSH Terms

Conditions

ObesityMotor ActivityInsulin Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Jill Kanaley, PhD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: All subjects will complete 3 study conditions with a minimum of one week between each condition.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

October 14, 2021

First Posted

October 27, 2021

Study Start

August 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

March 10, 2023

Record last verified: 2023-03

Locations