Sleep Restriction and Postprandial Lipemia
1 other identifier
interventional
10
1 country
2
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2022
2 active sites
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
July 1, 2022
CompletedFirst Submitted
Initial submission to the registry
January 13, 2023
CompletedFirst Posted
Study publicly available on registry
February 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedJanuary 31, 2024
January 1, 2024
1.4 years
January 13, 2023
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 COMPARATOR75 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))
no exercise, SR
EXPERIMENTAL75 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)
Exercise, no SR
EXPERIMENTAL75 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))
Exercise, SR
EXPERIMENTAL75 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)
Interventions
A high fat meal (milkshake) will be administered on the morning after the intervention of no exercise and no SR the night before.
Eligibility Criteria
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
University of Missouri
Columbia, Missouri, 65211, United States
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.
PMID: 40294439DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jill Kanaley, PhD
University of Missouri-Columbia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- 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
- 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
We will share deidentifiable data that is collected