Sleep DeprivationNCT05713370
Sleep Restriction and Postprandial Lipemia
A study testing high fat meal in people with Sleep Deprivation and Obesity, run by University of Missouri-Columbia at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Obesity
- What is being tested?
- high fat meal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2022to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- type 2 diabetic
- diagnosed with cardiovascular disease
- hypertensive
- smokers
- pregnant
- taking lipid-lowering medications
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Misouri
Columbia, Missouri, 65211
University of Missouri
Columbia, Missouri, 65211
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Sleep Deprivation, Obesity
- Being tested
- high fat meal
- Medical subject headings
- Sleep Deprivation, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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)) Receives: 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) Receives: 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)) Receives: 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) Receives: Dietary Supplement: high fat meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
area under the curve of fatty acids concentrations
blood samples for free fatty acid concentrations will be taken every 30 minutes for 4 hours
Measured: 4 hour
area under the curve of triglycerides concentrations
blood samples for triglyceride concentrations will be taken every 30 minutes for 4 hours
Measured: 4 hour
Secondary outcomes (1)
area under the curve of glucose concentrations
blood samples for glucose concentrations will be taken every 30 minutes for 4 hours
Measured: 4 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start1 Jul 2022
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects will complete all arms of the study in a counterbalanced design
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jill Kanaley, University of Missouri-Columbia
- Investigators
- Jill Kanaley, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713370
- Sponsor's protocol ID
- 2090503
- Status last verified
- Jan 2024
- First submitted
- 13 Jan 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share deidentifiable data that is collected
Publications
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.
PubMed 40294439
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Restriction and Postprandial Lipemia
- ClinicalTrials.gov ID
- NCT05713370
- Acronym / sponsor ID
- 2090503
- Conditions
- Sleep Deprivation, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Subjects will complete all arms of the study in a counterbalanced design
| Arm | Type | Receives |
|---|---|---|
| no exercise, no SR | Placebo comparator | Dietary Supplement: high fat meal75 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 | Experimental | Dietary Supplement: high fat meal75 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 | Experimental | Dietary Supplement: high fat meal75 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 | Experimental | Dietary Supplement: high fat meal75 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) |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- type 2 diabetic
- diagnosed with cardiovascular disease
- hypertensive
- smokers
- pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high fat mealA high fat meal (milkshake) will be administered on the morning after the intervention of no exercise and no SR the night before. | Dietary supplement | Exercise, SR, Exercise, no SR, no exercise, SR, no exercise, no SR |
Primary outcome
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
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
1 secondary outcome
area under the curve of glucose concentrations
Time frame: 4 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Derived from this study: PubMed 40294439Maloney 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.
- Individual participant dataSharing planned: Yes. We will share deidentifiable data that is collected
Related trials for Sleep Deprivation
Not yet recruiting
Study on the Mechanism of Central Obesity Induced by Sleep Restriction and the Therapeutic Effect of n-3 Polyunsaturated Fatty Acid: a Randomized, Double-blind, Placebo-controlled Trial (COSPA Study)
Sleep Deprivation
Recruiting
Sleep and Circadian Rhythm Intervention in ICU
ICU Hospitalization, Circadian Rhythm
Recruiting
Effect of Sleep Extension in Prevention to Sleep Deprivation
Healthy
Not yet recruiting
Evolution of Sleep in Intensive Care Unit Patients
ICU, Sleep Deprivation
Active, not recruiting
The Effect of Sleep Deprivation and Recovery Sleep on Emotional Memory and Affective Reactivity
Sleep Deprivation, Sleep
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill Kanaley, PhD principal investigator
University of Missouri-Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high fat meal in people with Sleep Deprivation and Obesity, run by University of Missouri-Columbia at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
area under the curve of fatty acids concentrations (time frame: 4 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05713370, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024; AzTrials last refreshed its copy on 28 Oct 2026.