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Olfactory Contributions to Sleep-dependent Food Craving

Olfactory Contributions to Sleep-dependent Food Craving and Calorie Intake

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04179838
Acronym
SDFC
Enrollment
29
Registered
2019-11-27
Start date
2016-09-19
Completion date
2017-08-15
Last updated
2020-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Deprivation

Brief summary

This within-subject experiment uses one night of acute sleep restriction (4h) vs normal sleep (8h) to study state-dependent changes in olfactory processing. Odor-evoked blood oxygen level dependent (BOLD) responses will be measured in olfactory brain regions using functional magnetic resonance imaging (fMRI). Food intake will be measured at a buffet.

Detailed description

This randomized within-subject sleep-deprivation protocol is designed to examine the effects of reduced sleep on neural processing of food odors in olfactory brain areas. Subjects will be healthy, normal-weight subjects (N=30) with comparable regular sleep patterns. They will be pseudorandomly assigned to first participate in either the sleep deprived (SD) or the non-deprived (ND) session, and then undergo a 7-day sleep stabilization phase during which subjects will maintain a regular sleep schedule of 8 h (within pre-determined range of 10:30 pm to 7:30 am). After sleep stabilization, subjects will either sleep normally (ND, 8h between 11pm and 7am), or sleep for only for 4h (SD, between 1am and 5am), at home. During the sleep stabilization phase and the night of sleep deprivation, sleep duration, as well as sleep and wakeup time will be recorded using actigraphy (ActiGraph, LLC, Pensacola, Florida). All subjects will participate in both sessions (SD and ND) with the two sessions being separated by 4 weeks. In the evening of the next day, olfactory fMRI will be conducted after dinner. Isocaloric meals will be provided during the 24h before fMRI and no beverages other than water will be permitted. After fMRI, subjects will have ad libitum access to high-caloric snacks in the form of an all-you-can-eat buffet. During initial screening, subjects will rate the pleasantness of six food odors, including three high-caloric sweet odors (caramel, yellow cake, ginger bread) and three high-caloric savory odors (potato chips, pot roast, garlic butter). Based on each participant's ratings, two sweet and two savory odors that are matched in pleasantness will be selected. In addition, two non-food control odors (fir needle and celery seed) will be used. On the evening after the sleep manipulation, subjects will arrive at the imaging center at 5:15pm, and will consume an isocaloric dinner at 6pm before entering the scanner at 7pm. Neuroimaging will be performed on a Siemens PRISMA system with a 64 channel head/neck coil, using imaging sequences optimized for signal recovery in olfactory and orbitofrontal cortices. Subjects will participate in 4 runs of olfactory stimulation inside the scanner and BOLD responses will be acquired with high spatial (2 mm isotopic) and temporal resolution (2000 ms). On each trial, subjects will be visually cued to sniff, and an odor (food or non-food) or non-odorized air will be delivered. Subsequently, subjects will rate the pleasantness or the intensity of the odor (pseudo-randomized). Sniffing will be measured using an fMRI-compatible breathing belt and spirometer. A high-resolution anatomical image will be acquired for the purpose of spatial normalization and anatomical localization of the fMRI responses. Upon arrival at the imaging center, a study study nurse will insert an intravenous sterile heparin-lock catheter in the left forearm vein and initiate blood sampling. Blood will be drawn every 30 min after arrival, resulting in 5 samples: before dinner, after dinner, before fMRI, during fMRI, and after fMRI. At the completion of fMRI, participants will be provided with a buffet where they have ad libitum access to high-caloric food items (sweet \[mini muffins, cinnamon buns, chocolate chip cookies, and doughnut holes\] and savory high-calorie snacks \[pizza bites, potato chips, hash browns, garlic bread\]). Subjects will be instructed to consume as much food as they like. All food items will be weighed pre- and post-consumption, and the consumed calories will be calculated.

Interventions

BEHAVIORALSleep-Deprived

Sleep for 4 hours at home.

BEHAVIORALNon-Sleep Deprived

Sleep for 8 hours at home.

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* age between 18 and 40 years old * regular sleep schedule (average sleep duration of ≥7 h/night, habitual mid-sleep time 3-5 am \[deviation ≤2 h in daily mid-sleep time\], time in bed ≤9 h) * right-handed * fluent English speakers

Exclusion criteria

* history of significant cerebrovascular disease including (but not limited to) epilepsy, stroke, multiple sclerosis, meningitis * body mass index (BMI) below 18.5 (underweight) or above 24.9 (overweight or obese) * history of sleep disorder * job with night shifts * history of major head trauma with sustained loss of consciousness * history of neurosurgery, ear-nose-throat (ENT) surgery, or cardiac surgery * history of cardiac pacemaker or neurostimulator implantation * history of significant medical illness including cardiovascular disease, diabetes, cancer, chronic obstructive pulmonary disease, severe asthma requiring hospitalization for treatment, renal insufficiency requiring dialysis, etc. * history of major psychiatric disorder including major affective disorder, obsessive-compulsive disorder, schizophrenia * claustrophobia * history of significant food or non-food allergy, including latex, detergents, soaps * presence of known smell, taste or ENT disorder * history of sinusitis or allergic rhinitis * history of alcoholism or consistent drug use * current smoking * current use of medications that affect alertness (e.g. barbiturates, benzodiazepines, cannabinoids, chloral hydrate, haloperidol, lithium, carbamazepine, phenytoin, etc.) * current pregnancy (or possible pregnancy) * history of metal working, or injury with shrapnel or metal slivers

Design outcomes

Primary

MeasureTime frameDescription
Functional Magnetic Resonance Imaging (fMRI)-Based Decoding Accuracy of Food vs Non-food Odors in Piriform CortexA single time point, in the evening (~19 h) after both the night of the Sleep-Deprived and the Non-Deprived intervention.In the evening after the night of the Sleep-Deprived and the Non-Sleep Deprived intervention, odor-evoked brain responses were collected using fMRI. fMRI data was analyzed using searchlight-based support vector machines and leave-one-run-out cross-validation to decode information about food vs. non-food odors. For each participant, this resulted in two maps of decoding accuracy (% data points correctly classified as food or non-food odors), one map per intervention. The measure of interest was decoding accuracy extracted from the piriform cortex.

Secondary

MeasureTime frameDescription
GhrelinA single time point, in the evening (~19.5 h) after both the night of the Sleep-Deprived and the Non-Deprived intervention.Ghrelin levels in blood samples (ng/mL) collected in the evening after the night of the Sleep-Deprived and the Non-Sleep Deprived intervention.
LeptinA single time point, in the evening (~19.5 h) after both the night of the Sleep-Deprived and the Non-Deprived intervention.Leptin levels in blood samples (ng/mL) collected in the evening after the night of the Sleep-Deprived and the Non-Sleep Deprived intervention.
Energy-density of Consumed FoodA single time point, in the evening (~20 h) after both the night of the Sleep-Deprived and the Non-Deprived intervention.Energy-density (kcal/g) of the food items consumed at the buffet provided after fMRI scanning in the evening after the night of the Sleep-Deprived and the Non-Sleep Deprived intervention.
InsulinA single time point, in the evening (~19.5 h) after both the night of the Sleep-Deprived and the Non-Deprived intervention.Insulin levels in blood samples (uU/mL) collected in the evening after the night of the Sleep-Deprived and the Non-Sleep Deprived intervention.
CortisolA single time point, in the evening (~19.5 h) after both the night of the Sleep-Deprived and the Non-Deprived intervention.Cortisol levels in blood samples (ug/dl) collected in the evening after the night of the Sleep-Deprived and the Non-Sleep Deprived intervention.
Total Calories of Consumed FoodA single time point, in the evening (~20 h) after both the night of the Sleep-Deprived and the Non-Deprived intervention.Total calories (kcal) of the food items consumed at the buffet provided after fMRI scanning in the evening after the night of the Sleep-Deprived and the Non-Sleep Deprived intervention.

Participant flow

Participants by arm

ArmCount
Sleep-Deprived First, Then Non-Sleep Deprived
Participants will first be tested after 1 night with partial sleep deprivation (sleep-deprived, 4 h sleep). After a washout period of 4 weeks, they will be tested again after 1 night with normal sleep (non-sleep deprived, 8 h sleep).
13
Non-Sleep Deprived First, Then Sleep-deprived
Participants will first be tested after 1 night with normal sleep (non-sleep deprived, 8 h sleep). After a washout period of 4 weeks, they will be tested again after 1 night with partial sleep deprivation (sleep-deprived, 4 h sleep).
12
Total25

Withdrawals & dropouts

PeriodReasonFG000FG001
First Intervention (1 Day)Withdrawal by Subject03
Second Intervention (1 Day)Protocol Violation01

Baseline characteristics

CharacteristicSleep-Deprived First, Then Non-Sleep DeprivedTotalNon-Sleep Deprived First, Then Sleep-deprived
Age, Continuous26.3 years
STANDARD_DEVIATION 4.46
26.64 years
STANDARD_DEVIATION 4.91
27 years
STANDARD_DEVIATION 5.54
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants2 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
12 Participants23 Participants11 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
4 Participants6 Participants2 Participants
Race (NIH/OMB)
Black or African American
1 Participants2 Participants1 Participants
Race (NIH/OMB)
More than one race
1 Participants3 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
7 Participants14 Participants7 Participants
Region of Enrollment
United States
13 participants25 participants12 participants
Sex: Female, Male
Female
10 Participants15 Participants5 Participants
Sex: Female, Male
Male
3 Participants10 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 290 / 29
other
Total, other adverse events
0 / 290 / 29
serious
Total, serious adverse events
0 / 290 / 29

Outcome results

Primary

Functional Magnetic Resonance Imaging (fMRI)-Based Decoding Accuracy of Food vs Non-food Odors in Piriform Cortex

In the evening after the night of the Sleep-Deprived and the Non-Sleep Deprived intervention, odor-evoked brain responses were collected using fMRI. fMRI data was analyzed using searchlight-based support vector machines and leave-one-run-out cross-validation to decode information about food vs. non-food odors. For each participant, this resulted in two maps of decoding accuracy (% data points correctly classified as food or non-food odors), one map per intervention. The measure of interest was decoding accuracy extracted from the piriform cortex.

Time frame: A single time point, in the evening (~19 h) after both the night of the Sleep-Deprived and the Non-Deprived intervention.

ArmMeasureValue (MEAN)Dispersion
Sleep-DeprivedFunctional Magnetic Resonance Imaging (fMRI)-Based Decoding Accuracy of Food vs Non-food Odors in Piriform Cortex54.38 Percentage correctly classifiedStandard Error 0.81
Non-Sleep DeprivedFunctional Magnetic Resonance Imaging (fMRI)-Based Decoding Accuracy of Food vs Non-food Odors in Piriform Cortex49.65 Percentage correctly classifiedStandard Error 0.68
Comparison: Null hypothesis is that there was no difference in decoding accuracy between sleep-deprived and non-sleep deprived interventions. Paired t-test on decoding accuracy from both phases (sleep-deprived minus non-sleep deprived) against the null hypothesis of no difference.p-value: 0.001t-test, 1 sided
Secondary

Cortisol

Cortisol levels in blood samples (ug/dl) collected in the evening after the night of the Sleep-Deprived and the Non-Sleep Deprived intervention.

Time frame: A single time point, in the evening (~19.5 h) after both the night of the Sleep-Deprived and the Non-Deprived intervention.

ArmMeasureValue (MEAN)Dispersion
Sleep-DeprivedCortisol6.08 ug/dlStandard Error 0.73
Non-Sleep DeprivedCortisol7.50 ug/dlStandard Error 1.17
Comparison: Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.p-value: 0.58t-test, 2 sided
Secondary

Energy-density of Consumed Food

Energy-density (kcal/g) of the food items consumed at the buffet provided after fMRI scanning in the evening after the night of the Sleep-Deprived and the Non-Sleep Deprived intervention.

Time frame: A single time point, in the evening (~20 h) after both the night of the Sleep-Deprived and the Non-Deprived intervention.

ArmMeasureValue (MEAN)Dispersion
Sleep-DeprivedEnergy-density of Consumed Food3.88 kcal/gStandard Error 0.12
Non-Sleep DeprivedEnergy-density of Consumed Food3.68 kcal/gStandard Error 0.11
Comparison: Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.p-value: 0.021t-test, 1 sided
Secondary

Ghrelin

Ghrelin levels in blood samples (ng/mL) collected in the evening after the night of the Sleep-Deprived and the Non-Sleep Deprived intervention.

Time frame: A single time point, in the evening (~19.5 h) after both the night of the Sleep-Deprived and the Non-Deprived intervention.

ArmMeasureValue (MEAN)Dispersion
Sleep-DeprivedGhrelin584.33 ng/mLStandard Error 42.78
Non-Sleep DeprivedGhrelin573.47 ng/mLStandard Error 38.23
Comparison: Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.p-value: 0.63t-test, 2 sided
Secondary

Insulin

Insulin levels in blood samples (uU/mL) collected in the evening after the night of the Sleep-Deprived and the Non-Sleep Deprived intervention.

Time frame: A single time point, in the evening (~19.5 h) after both the night of the Sleep-Deprived and the Non-Deprived intervention.

ArmMeasureValue (MEAN)Dispersion
Sleep-DeprivedInsulin42.53 uU/mLStandard Error 5.04
Non-Sleep DeprivedInsulin48.56 uU/mLStandard Error 5.15
Comparison: Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.p-value: 0.5t-test, 2 sided
Secondary

Leptin

Leptin levels in blood samples (ng/mL) collected in the evening after the night of the Sleep-Deprived and the Non-Sleep Deprived intervention.

Time frame: A single time point, in the evening (~19.5 h) after both the night of the Sleep-Deprived and the Non-Deprived intervention.

ArmMeasureValue (MEAN)Dispersion
Sleep-DeprivedLeptin10.19 ng/mLStandard Error 1.58
Non-Sleep DeprivedLeptin9.68 ng/mLStandard Error 1.53
Comparison: Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.p-value: 0.08t-test, 2 sided
Secondary

Total Calories of Consumed Food

Total calories (kcal) of the food items consumed at the buffet provided after fMRI scanning in the evening after the night of the Sleep-Deprived and the Non-Sleep Deprived intervention.

Time frame: A single time point, in the evening (~20 h) after both the night of the Sleep-Deprived and the Non-Deprived intervention.

ArmMeasureValue (MEAN)Dispersion
Sleep-DeprivedTotal Calories of Consumed Food932.86 kcalStandard Error 72.55
Non-Sleep DeprivedTotal Calories of Consumed Food946.49 kcalStandard Error 87.64
Comparison: Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.p-value: 0.28t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026