Trial Outcomes & Findings for Olfactory Contributions to Sleep-dependent Food Craving (NCT NCT04179838)
NCT ID: NCT04179838
Last Updated: 2020-03-25
Results Overview
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.
COMPLETED
NA
29 participants
A single time point, in the evening (~19 h) after both the night of the "Sleep-Deprived" and the "Non-Deprived" intervention.
2020-03-25
Participant Flow
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
First Intervention (1 Day)
STARTED
|
13
|
16
|
|
First Intervention (1 Day)
COMPLETED
|
13
|
13
|
|
First Intervention (1 Day)
NOT COMPLETED
|
0
|
3
|
|
Washout (4 Weeks)
STARTED
|
13
|
13
|
|
Washout (4 Weeks)
COMPLETED
|
13
|
13
|
|
Washout (4 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (1 Day)
STARTED
|
13
|
13
|
|
Second Intervention (1 Day)
COMPLETED
|
13
|
12
|
|
Second Intervention (1 Day)
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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).
|
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).
|
|---|---|---|
|
First Intervention (1 Day)
Withdrawal by Subject
|
0
|
3
|
|
Second Intervention (1 Day)
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Olfactory Contributions to Sleep-dependent Food Craving
Baseline characteristics by cohort
| Measure |
Sleep-Deprived First, Then Non-Sleep Deprived
n=13 Participants
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).
|
Non-Sleep Deprived First, Then Sleep-deprived
n=12 Participants
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).
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.3 years
STANDARD_DEVIATION 4.46 • n=5 Participants
|
27 years
STANDARD_DEVIATION 5.54 • n=7 Participants
|
26.64 years
STANDARD_DEVIATION 4.91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: A 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.
Outcome measures
| Measure |
Sleep-Deprived
n=25 Participants
Participants who were sleep-deprived in either the first or the second phase of the study.
|
Non-Sleep Deprived
n=25 Participants
Participants who were non-sleep deprived in either the first or the second phase of the study.
|
|---|---|---|
|
Functional Magnetic Resonance Imaging (fMRI)-Based Decoding Accuracy of Food vs Non-food Odors in Piriform Cortex
|
54.38 Percentage correctly classified
Standard Error 0.81
|
49.65 Percentage correctly classified
Standard Error 0.68
|
SECONDARY outcome
Timeframe: A 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.
Outcome measures
| Measure |
Sleep-Deprived
n=25 Participants
Participants who were sleep-deprived in either the first or the second phase of the study.
|
Non-Sleep Deprived
n=25 Participants
Participants who were non-sleep deprived in either the first or the second phase of the study.
|
|---|---|---|
|
Energy-density of Consumed Food
|
3.88 kcal/g
Standard Error 0.12
|
3.68 kcal/g
Standard Error 0.11
|
SECONDARY outcome
Timeframe: A 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.
Outcome measures
| Measure |
Sleep-Deprived
n=25 Participants
Participants who were sleep-deprived in either the first or the second phase of the study.
|
Non-Sleep Deprived
n=25 Participants
Participants who were non-sleep deprived in either the first or the second phase of the study.
|
|---|---|---|
|
Ghrelin
|
584.33 ng/mL
Standard Error 42.78
|
573.47 ng/mL
Standard Error 38.23
|
SECONDARY outcome
Timeframe: A 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.
Outcome measures
| Measure |
Sleep-Deprived
n=25 Participants
Participants who were sleep-deprived in either the first or the second phase of the study.
|
Non-Sleep Deprived
n=25 Participants
Participants who were non-sleep deprived in either the first or the second phase of the study.
|
|---|---|---|
|
Leptin
|
10.19 ng/mL
Standard Error 1.58
|
9.68 ng/mL
Standard Error 1.53
|
SECONDARY outcome
Timeframe: A 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.
Outcome measures
| Measure |
Sleep-Deprived
n=25 Participants
Participants who were sleep-deprived in either the first or the second phase of the study.
|
Non-Sleep Deprived
n=25 Participants
Participants who were non-sleep deprived in either the first or the second phase of the study.
|
|---|---|---|
|
Total Calories of Consumed Food
|
932.86 kcal
Standard Error 72.55
|
946.49 kcal
Standard Error 87.64
|
SECONDARY outcome
Timeframe: A 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.
Outcome measures
| Measure |
Sleep-Deprived
n=25 Participants
Participants who were sleep-deprived in either the first or the second phase of the study.
|
Non-Sleep Deprived
n=25 Participants
Participants who were non-sleep deprived in either the first or the second phase of the study.
|
|---|---|---|
|
Insulin
|
42.53 uU/mL
Standard Error 5.04
|
48.56 uU/mL
Standard Error 5.15
|
SECONDARY outcome
Timeframe: A 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.
Outcome measures
| Measure |
Sleep-Deprived
n=25 Participants
Participants who were sleep-deprived in either the first or the second phase of the study.
|
Non-Sleep Deprived
n=25 Participants
Participants who were non-sleep deprived in either the first or the second phase of the study.
|
|---|---|---|
|
Cortisol
|
6.08 ug/dl
Standard Error 0.73
|
7.50 ug/dl
Standard Error 1.17
|
Adverse Events
Sleep-Deprived
Non-Sleep Deprived
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place