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Sleep Restriction and Postprandial Lipemia

Primary Purpose

Sleep Deprivation, Obesity

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
high fat meal
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sleep Deprivation

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Misouri
  • University of Missouri

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

no exercise, no SR

no exercise, SR

Exercise, no SR

Exercise, SR

Arm Description

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))

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)

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))

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)

Outcomes

Primary Outcome Measures

area under the curve of fatty acids concentrations
blood samples for free fatty acid concentrations will be taken every 30 minutes for 4 hours
area under the curve of triglycerides concentrations
blood samples for triglyceride concentrations will be taken every 30 minutes for 4 hours

Secondary Outcome Measures

area under the curve of glucose concentrations
blood samples for glucose concentrations will be taken every 30 minutes for 4 hours

Full Information

First Posted
January 13, 2023
Last Updated
July 18, 2023
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT05713370
Brief Title
Sleep Restriction and Postprandial Lipemia
Official Title
Sleep Restriction and Postprandial Lipemia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Subjects will complete all arms of the study in a counterbalanced design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
no exercise, no SR
Arm Type
Placebo Comparator
Arm Description
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))
Arm Title
no exercise, SR
Arm Type
Experimental
Arm Description
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)
Arm Title
Exercise, no SR
Arm Type
Experimental
Arm Description
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))
Arm Title
Exercise, SR
Arm Type
Experimental
Arm Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
high fat meal
Intervention Description
A high fat meal (milkshake) will be administered on the morning after the intervention of no exercise and no SR the night before.
Primary Outcome Measure Information:
Title
area under the curve of fatty acids concentrations
Description
blood samples for free fatty acid concentrations will be taken every 30 minutes for 4 hours
Time Frame
4 hour
Title
area under the curve of triglycerides concentrations
Description
blood samples for triglyceride concentrations will be taken every 30 minutes for 4 hours
Time Frame
4 hour
Secondary Outcome Measure Information:
Title
area under the curve of glucose concentrations
Description
blood samples for glucose concentrations will be taken every 30 minutes for 4 hours
Time Frame
4 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Kanaley, PhD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Misouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We will share deidentifiable data that is collected
IPD Sharing 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

Learn more about this trial

Sleep Restriction and Postprandial Lipemia

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