- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05713370
Sleep Restriction and Postprandial Lipemia
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In the postprandial period, adipocytes respond to the increased insulin levels by suppressing intracellular triglycerides (TG) lipolysis and by increasing extracellular lipolysis by transporting lipoprotein lipase from intracellular vesicles to the surface of the endothelium. This results in decreased free fatty acids (FFA) release into the plasma and increased absorption of lipoprotein TGs, particularly those in chylomicrons and VLDLs.
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. Sleep restriction can also alter whole body substrate metabolism such that there is a trend for increased lipid oxidation. Additionally, research examining the effects of short-term sleep restriction on circulating lipids have had mixed results. A number of studies have found decreases in fasting TG while other studies found no change in plasma TGs with sleep restriction.
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 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 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 triglyceride (TG) concentrations while a one way ANOVA will be used to analyze area under the curve of the NEFA and TG concentrations.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
Columbia, Missouri, United States, 65211
- University of Missouri
-
Columbia, Missouri, United States, 65211
- University of Misouri
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Overweight and obese men and women
- 21-45 years of age
- BMI of 25-35 kg/m2
- Normal sleeping habits of 7-9 hours per night
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: no exercise, no SR
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))
|
A high fat meal (milkshake) will be administered on the morning after the intervention of no exercise and no SR the night before.
|
|
Experimental: no exercise, SR
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)
|
A high fat meal (milkshake) will be administered on the morning after the intervention of no exercise and no SR the night before.
|
|
Experimental: Exercise, no SR
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))
|
A high fat meal (milkshake) will be administered on the morning after the intervention of no exercise and no SR the night before.
|
|
Experimental: Exercise, SR
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)
|
A high fat meal (milkshake) will be administered on the morning after the intervention of no exercise and no SR the night before.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
area under the curve of fatty acids concentrations
Time Frame: 4 hour
|
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
Time Frame: 4 hour
|
blood samples for triglyceride concentrations will be taken every 30 minutes for 4 hours
|
4 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
area under the curve of glucose concentrations
Time Frame: 4 hour
|
blood samples for glucose concentrations will be taken every 30 minutes for 4 hours
|
4 hour
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jill Kanaley, PhD, University of Missouri-Columbia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2090503
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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