NCT05713370

Brief Summary

Sleep restriction increases overnight and early morning non-esterified fatty acids (NEFA) levels, which are correlated with whole-body decreases in insulin sensitivity, consistent with the observed impairment of intracellular insulin signaling. Adipose tissue biopsies from sleep restricted subjects that are insulin stimulated have reduced phosphorylation of protein kinase B (pAKT). This protein is involved in suppression of intracellular lipolysis and NEFA release. Aerobic exercise has beneficial effects on postprandial lipemia and insulinemia in normal-weight and obese individuals. Acute moderate-intensity aerobic exercise (30-90 min) performed 12-18 h before an oral fat tolerance test or mixed meal test reduces postprandial triglycerides (TG) and insulin concentrations. This response is largely dependent upon the exercise-induced energy deficit as the response is abolished when the calories expended during exercise are replaced. However, it is not known if sleep restriction will interfere with the beneficial effects of prior exercise on postprandial lipemia. The aim of this project is to investigate if sleep restriction negates the positive effect that exercise has on postprandial lipemia. It is hypothesized that sleep restriction will negate the beneficial effects of prior exercise on postprandial lipemia. Additionally sleep restriction will result in a worsening of the lipid profile compared to no exercise. For the proposed study, the investigators will use a repeated measures analysis of variance (ANOVA) (4 study conditions (no exercise+ sleep restriction, no exercise+normal sleep, exercise+normal sleep, exercise+sleep restriction) x time will be used to analyze changes in NEFA and TG concentrations while a one way ANOVA will be used to analyze area under the curve of the NEFA and TG concentrations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

July 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

1.4 years

First QC Date

January 13, 2023

Last Update Submit

January 29, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • area under the curve of fatty acids concentrations

    blood samples for free fatty acid concentrations will be taken every 30 minutes for 4 hours

    4 hour

  • area under the curve of triglycerides concentrations

    blood samples for triglyceride concentrations will be taken every 30 minutes for 4 hours

    4 hour

Secondary Outcomes (1)

  • area under the curve of glucose concentrations

    4 hour

Study Arms (4)

no exercise, no SR

PLACEBO COMPARATOR

75 g of glucose will be given at the beginning of the study day (the evening prior there will be no exercise the night before the study day, normal sleep (8 h))

Dietary Supplement: high fat meal

no exercise, SR

EXPERIMENTAL

75 g of glucose will be given at the beginning of the study day (the evening prior there will be no exercise the night before the study day, 4 h of sleep the previous night)

Dietary Supplement: high fat meal

Exercise, no SR

EXPERIMENTAL

75 g of glucose will be given at the beginning of the study day (the evening prior there will be 45 min of exercise the night before the study day, normal sleep (8 h))

Dietary Supplement: high fat meal

Exercise, SR

EXPERIMENTAL

75 g of glucose will be given at the beginning of the study day (the evening prior there will be 45 min of exercise the night before the study day, 4 h of sleep the previous night)

Dietary Supplement: high fat meal

Interventions

high fat mealDIETARY_SUPPLEMENT

A high fat meal (milkshake) will be administered on the morning after the intervention of no exercise and no SR the night before.

Exercise, SRExercise, no SRno exercise, SRno exercise, no SR

Eligibility Criteria

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

You may qualify if:

  • Overweight and obese men and women
  • years of age
  • BMI of 25-35 kg/m2
  • Normal sleeping habits of 7-9 hours per night

You may not qualify if:

  • type 2 diabetic
  • diagnosed with cardiovascular disease
  • hypertensive
  • smokers
  • pregnant
  • taking lipid-lowering medications
  • sleep apnea
  • fragmented sleep
  • have any recent changes in hormonal birth control
  • night shift workers or take regular daytime naps
  • any medications known to impact metabolism, appetite, or sleep
  • any allergies to milk, ice cream, peanut butter and soy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Misouri

Columbia, Missouri, 65211, United States

Location

University of Missouri

Columbia, Missouri, 65211, United States

Location

Related Publications (1)

  • Maloney A, McDonald M, Petroski G, Kanaley JA. Effect of sleep restriction, with or without prior evening exercise, on morning postprandial lipemia. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-10. doi: 10.1139/apnm-2024-0535.

MeSH Terms

Conditions

Sleep DeprivationObesity

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Study Officials

  • Jill Kanaley, PhD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Subjects will complete all arms of the study in a counterbalanced design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 13, 2023

First Posted

February 6, 2023

Study Start

July 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

January 31, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

We will share deidentifiable data that is collected

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The data will not be shared until at least 2 years after data collection is completed. Data will be available for another 3 years

Locations