Healthy
Conditions
Brief summary
The purpose of this study is to look at how a two-week use of a medication called Olanzapine might change appetite, physical activity, resting metabolic rate, body composition, and weight in healthy men.
Interventions
DRUGOlanzapine
Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
DRUGPlacebo
Placebo capsule administered orally at bedtime for 14 days
Sponsors
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Volunteer * Male * Aged 18-35 years * Body Mass Index (BMI): \<30 kg/m2
Exclusion criteria
* Presence of any medical disorder that may confound the assessment of relevant biological measures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Weight | Assessed at baseline and 2 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Body Composition | baseline and 2 weeks of treatment (olanzapine or placebo) | lean body mass (kg) and fat mass (kg) at baseline and after 2 weeks of treatment with olanzapine or placebo |
| Change From Baseline in 24-Hour Dietary Recall | Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo) | 24-hour dietary intake recall at baseline and after 2 weeks of treatment with olanzapine or placebo |
| Change From Baseline in Resting Metabolic Rate | baseline and 2weeks of treatment | Resting metabolic rate at baseline and after 2 weeks of treatment |
| Change From Baseline Triglycerides | Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo) | Triglycerides (mg/dl) at baseline and after 2 weeks of treatment with olanzapine or placebo |
| Change From Baseline in Glucose | Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo) | Glucose (mg/dl) at baseline and after 2 weeks of treatment with olanzapine or placebo |
| Change From Baseline in Insulin | Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo) | Insulin (µIU/ml) at baseline and after 2 weeks of treatment with olanzapine or placebo |
| Change From Baseline Total Cholesterol | baseline and 2 weeks treatment | Total cholesterol at baseline and after 2 weeks treatment with olanzapine or placebo |
| LDL | baseline and 2 weeks treatment | Low-density lipoprotein at baseline and after 2 weeks of treatment with olanzapine or placebo |
| HDL | baseline and 2 weeks treatment | High-density lipoprotein at baseline and after 2 weeks of treatment with olanzapine or placebo |
| Physical Activity as Measured Using a Physical Activity Monitor | baseline and 2 week treatment | Change from baseline in physical activity. Physical activity was measured using an activity monitor that subjects wore around their waist throughout baseline and treatment days. Subjects were instructed to remove the monitor when sleeping or engaging in water-based activities, and to report on a daily log the times that they were wearing and removing the device. Physical activity was monitored during weekdays and weekend days. Physical activity data were collected in 60-second epochs. The results are reported as average counts per day of physical activity for weekdays and weekend days at baseline and 2 week treatment. |
| Change From Baseline in Leptin | Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo) | Leptin (ng/ml) at baseline and after 2 weeks of treatment with olanzapine or placebo |
Other
| Measure | Time frame | Description |
|---|---|---|
| Laboratory Breakfast Intake | baseline and 2 week treatment | Total kcal intake at breakfast in a laboratory setting at baseline and after 2 week of treatment with olanzapine or placebo |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo: Placebo capsule administered orally at bedtime for 14 days | 6 |
| Olanzapine Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days. | 13 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 3 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Olanzapine | Total |
|---|---|---|---|
| Age, Continuous | 24.8 years STANDARD_DEVIATION 2.5 | 23.1 years STANDARD_DEVIATION 5.1 | 23.6 years STANDARD_DEVIATION 4.4 |
| Region of Enrollment United States | 6 participants | 13 participants | 19 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 13 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 13 |
| serious Total, serious adverse events | 0 / 6 | 0 / 13 |
Outcome results
Primary
Change From Baseline in Weight
Time frame: Assessed at baseline and 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Weight | 0.2 Kg | Standard Deviation 0.5 |
| Olanzapine | Change From Baseline in Weight | 1.7 Kg | Standard Deviation 1.1 |
Secondary
Change From Baseline in 24-Hour Dietary Recall
24-hour dietary intake recall at baseline and after 2 weeks of treatment with olanzapine or placebo
Time frame: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in 24-Hour Dietary Recall | baseline | 1748 kcal/day | Standard Deviation 567 |
| Placebo | Change From Baseline in 24-Hour Dietary Recall | 2 weeks of treatment | 1785 kcal/day | Standard Deviation 562 |
| Olanzapine | Change From Baseline in 24-Hour Dietary Recall | baseline | 2410 kcal/day | Standard Deviation 1591 |
| Olanzapine | Change From Baseline in 24-Hour Dietary Recall | 2 weeks of treatment | 2374 kcal/day | Standard Deviation 1073 |
Secondary
Change From Baseline in Body Composition
lean body mass (kg) and fat mass (kg) at baseline and after 2 weeks of treatment with olanzapine or placebo
Time frame: baseline and 2 weeks of treatment (olanzapine or placebo)
Population: The Body Composition assessment was not implemented at the start of the study but once the study already started. Therefore, not all study participants who completed the study got the Body Composition assessment done. Only 3 participants in the Placebo Group and 6 participants in the Olanzapine Group got the Body Composition assessment done.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Body Composition | fat mass at 2 weeks of treatment | 18.5 kg | Standard Deviation 10 |
| Placebo | Change From Baseline in Body Composition | lean body mass at 2 weeks of treatment | 60.1 kg | Standard Deviation 1.7 |
| Placebo | Change From Baseline in Body Composition | lean body mass at baseline | 60.1 kg | Standard Deviation 0.7 |
| Placebo | Change From Baseline in Body Composition | fat mass at baseline | 17.9 kg | Standard Deviation 11.7 |
| Olanzapine | Change From Baseline in Body Composition | fat mass at baseline | 16.5 kg | Standard Deviation 9.4 |
| Olanzapine | Change From Baseline in Body Composition | lean body mass at 2 weeks of treatment | 67.0 kg | Standard Deviation 11.7 |
| Olanzapine | Change From Baseline in Body Composition | fat mass at 2 weeks of treatment | 17.4 kg | Standard Deviation 8.6 |
| Olanzapine | Change From Baseline in Body Composition | lean body mass at baseline | 65.8 kg | Standard Deviation 11.3 |
Secondary
Change From Baseline in Glucose
Glucose (mg/dl) at baseline and after 2 weeks of treatment with olanzapine or placebo
Time frame: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)
Population: Note regarding the difference between the Overall Number of Participants Analyzed and the Participant Flow: Blood sample could not be collected from 1 participant from the Placebo Group and 2 participants from the Olanzapine Group. Therefore, the number of participants analyzed for the Placebo Group is 5 and for the Olanzapine Group is 11.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Glucose | baseline | 82.4 mg/dl | Standard Deviation 7.4 |
| Placebo | Change From Baseline in Glucose | 2 weeks of treatment | 85.0 mg/dl | Standard Deviation 4.2 |
| Olanzapine | Change From Baseline in Glucose | baseline | 78.6 mg/dl | Standard Deviation 8.1 |
| Olanzapine | Change From Baseline in Glucose | 2 weeks of treatment | 82.2 mg/dl | Standard Deviation 5.3 |
Secondary
Change From Baseline in Insulin
Insulin (µIU/ml) at baseline and after 2 weeks of treatment with olanzapine or placebo
Time frame: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)
Population: Note regarding the difference between the Overall Number of Participants Analyzed and the Participant Flow: Blood sample could not be collected from 1 participant from the Placebo Group and 2 participants from the Olanzapine Group. Therefore, the number of participants analyzed for the Placebo Group is 5 and for the Olanzapine Group is 11.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Insulin | baseline | 5.0 µIU/ml | Standard Deviation 3.5 |
| Placebo | Change From Baseline in Insulin | 2 weeks of treatment | 5.8 µIU/ml | Standard Deviation 2.7 |
| Olanzapine | Change From Baseline in Insulin | baseline | 6.2 µIU/ml | Standard Deviation 4 |
| Olanzapine | Change From Baseline in Insulin | 2 weeks of treatment | 10.1 µIU/ml | Standard Deviation 7.5 |
Secondary
Change From Baseline in Leptin
Leptin (ng/ml) at baseline and after 2 weeks of treatment with olanzapine or placebo
Time frame: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)
Population: Note regarding the difference between the Overall Number of Participants Analyzed and the Participant Flow: Blood sample could not be collected from 1 participant from the Placebo Group and 2 participants from the Olanzapine Group. Therefore, the number of participants analyzed for the Placebo Group is 5 and for the Olanzapine Group is 11.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Leptin | 2 weeks treatment | 4.8 ng/ml | Standard Deviation 3 |
| Placebo | Change From Baseline in Leptin | baseline | 3.8 ng/ml | Standard Deviation 3.3 |
| Olanzapine | Change From Baseline in Leptin | 2 weeks treatment | 5.7 ng/ml | Standard Deviation 4.3 |
| Olanzapine | Change From Baseline in Leptin | baseline | 3.8 ng/ml | Standard Deviation 2.7 |
Secondary
Change From Baseline in Resting Metabolic Rate
Resting metabolic rate at baseline and after 2 weeks of treatment
Time frame: baseline and 2weeks of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Resting Metabolic Rate | baseline | 1702 kcal/24 hours | Standard Deviation 217 |
| Placebo | Change From Baseline in Resting Metabolic Rate | 2 weeks treatment | 1689 kcal/24 hours | Standard Deviation 309 |
| Olanzapine | Change From Baseline in Resting Metabolic Rate | baseline | 1855 kcal/24 hours | Standard Deviation 351 |
| Olanzapine | Change From Baseline in Resting Metabolic Rate | 2 weeks treatment | 1858 kcal/24 hours | Standard Deviation 342 |
Secondary
Change From Baseline Total Cholesterol
Total cholesterol at baseline and after 2 weeks treatment with olanzapine or placebo
Time frame: baseline and 2 weeks treatment
Population: Note regarding the difference between the Overall Number of Participants Analyzed and the Participant Flow: Blood sample could not be collected from 1 participant from the Placebo Group and 1 participant from the Olanzapine Group. Therefore, the number of participants analyzed for the Placebo Group is 5 and for the Olanzapine Group is 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline Total Cholesterol | baseline | 153.2 mg/dl | Standard Deviation 23.7 |
| Placebo | Change From Baseline Total Cholesterol | 2 weeks treatment | 147.4 mg/dl | Standard Deviation 21.1 |
| Olanzapine | Change From Baseline Total Cholesterol | baseline | 156.8 mg/dl | Standard Deviation 32.2 |
| Olanzapine | Change From Baseline Total Cholesterol | 2 weeks treatment | 167.0 mg/dl | Standard Deviation 42 |
Secondary
Change From Baseline Triglycerides
Triglycerides (mg/dl) at baseline and after 2 weeks of treatment with olanzapine or placebo
Time frame: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)
Population: Note regarding the difference between the Overall Number of Participants Analyzed and the Participant Flow: Blood sample could not be collected from 1 participant from the Placebo Group and 1 participant from the Olanzapine Group. Therefore, the number of participants analyzed for the Placebo Group is 5 and for the Olanzapine Group is 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline Triglycerides | 2 weeks of treatment | 52.8 mg/dl | Standard Deviation 22.1 |
| Placebo | Change From Baseline Triglycerides | baseline | 48.4 mg/dl | Standard Deviation 13.6 |
| Olanzapine | Change From Baseline Triglycerides | baseline | 93.0 mg/dl | Standard Deviation 38.1 |
| Olanzapine | Change From Baseline Triglycerides | 2 weeks of treatment | 136.6 mg/dl | Standard Deviation 80.2 |
Secondary
HDL
High-density lipoprotein at baseline and after 2 weeks of treatment with olanzapine or placebo
Time frame: baseline and 2 weeks treatment
Population: Note regarding the difference between the Overall Number of Participants Analyzed and the Participant Flow: Blood sample could not be collected from 1 participant from the Placebo Group and 1 participant from the Olanzapine Group. Therefore, the number of participants analyzed for the Placebo Group is 5 and for the Olanzapine Group is 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | HDL | baseline | 54.6 mg/dl | Standard Deviation 10.2 |
| Placebo | HDL | 2 weeks treatment | 55.0 mg/dl | Standard Deviation 6.8 |
| Olanzapine | HDL | baseline | 51.3 mg/dl | Standard Deviation 15.7 |
| Olanzapine | HDL | 2 weeks treatment | 46.1 mg/dl | Standard Deviation 11.2 |
Secondary
LDL
Low-density lipoprotein at baseline and after 2 weeks of treatment with olanzapine or placebo
Time frame: baseline and 2 weeks treatment
Population: Note regarding the difference between the Overall Number of Participants Analyzed and the Participant Flow: Blood sample could not be collected from 1 participant from the Placebo Group and 1 participant from the Olanzapine Group. Therefore, the number of participants analyzed for the Placebo Group is 5 and for the Olanzapine Group is 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | LDL | baseline | 88.8 mg/dl | Standard Deviation 25.2 |
| Placebo | LDL | 2 weeks treatment | 82.0 mg/dl | Standard Deviation 12.5 |
| Olanzapine | LDL | baseline | 86.9 mg/dl | Standard Deviation 29.2 |
| Olanzapine | LDL | 2 weeks treatment | 93.7 mg/dl | Standard Deviation 34.4 |
Secondary
Physical Activity as Measured Using a Physical Activity Monitor
Change from baseline in physical activity. Physical activity was measured using an activity monitor that subjects wore around their waist throughout baseline and treatment days. Subjects were instructed to remove the monitor when sleeping or engaging in water-based activities, and to report on a daily log the times that they were wearing and removing the device. Physical activity was monitored during weekdays and weekend days. Physical activity data were collected in 60-second epochs. The results are reported as average counts per day of physical activity for weekdays and weekend days at baseline and 2 week treatment.
Time frame: baseline and 2 week treatment
Population: Due to poor participant's compliance with the study requirements for physical activity data collection, the data from 4 participants from the olanzapine group could not be used for analysis purpose.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo | Physical Activity as Measured Using a Physical Activity Monitor | baseline - weekend days | 279,149 counts per day |
| Placebo | Physical Activity as Measured Using a Physical Activity Monitor | 2 week treatment - weekend days | 247,036 counts per day |
| Placebo | Physical Activity as Measured Using a Physical Activity Monitor | baseline - weekdays | 410,029 counts per day |
| Placebo | Physical Activity as Measured Using a Physical Activity Monitor | 2 week treatment - weekdays | 279,722 counts per day |
| Olanzapine | Physical Activity as Measured Using a Physical Activity Monitor | 2 week treatment - weekdays | 263,757 counts per day |
| Olanzapine | Physical Activity as Measured Using a Physical Activity Monitor | baseline - weekend days | 277,298 counts per day |
| Olanzapine | Physical Activity as Measured Using a Physical Activity Monitor | baseline - weekdays | 263,720 counts per day |
| Olanzapine | Physical Activity as Measured Using a Physical Activity Monitor | 2 week treatment - weekend days | 198,382 counts per day |
Other Pre-specified
Laboratory Breakfast Intake
Total kcal intake at breakfast in a laboratory setting at baseline and after 2 week of treatment with olanzapine or placebo
Time frame: baseline and 2 week treatment
Population: The Laboratory Breakfast Intake assessment was not performed at the start of the study but was initiated during the course of the study. Only 3 participants from the Placebo group and 6 participants from the Olanzapine group completed the Laboratory Breakfast Intake assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Laboratory Breakfast Intake | Baseline | 1396 kcal | Standard Deviation 160 |
| Placebo | Laboratory Breakfast Intake | 2 week treatment | 1567 kcal | Standard Deviation 478 |
| Olanzapine | Laboratory Breakfast Intake | 2 week treatment | 1058 kcal | Standard Deviation 482 |
| Olanzapine | Laboratory Breakfast Intake | Baseline | 864 kcal | Standard Deviation 269 |