Trial Outcomes & Findings for The Effects of Smell on Mood and Physical Responses (NCT NCT00097253)
NCT ID: NCT00097253
Last Updated: 2010-02-18
Results Overview
Cortisol, norepinephrine, epinephrine measured before and after physical (cold pressor) stressor, which occurred at 11:00.
COMPLETED
PHASE1
56 participants
3 Visits with at least 2 weeks between each. Average time to complete all visits was 64.46 days (SD 48.4). Cortisol: 9:05, 10:05, 10:55, 11:45, 12:15, 13:00. Nor/Epi: 9:05, 10:05, 10:55, 11:05, 11:45, 12:15
2010-02-18
Participant Flow
Participants were recruited through ads posted in the Columbus, Ohio area.
We excluded individuals taking cardiovascular medications or medications with obvious immunological or endocrinological consequences. Additional exclusion criteria included perfume allergies, smoking, problems with smell/taste, respiratory problems, asthma, excessive alcohol/caffeine use.
Participant milestones
| Measure |
Lavender Oil / Lemon Oil / Water Control
A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
|
|---|---|
|
Lavender
STARTED
|
56
|
|
Lavender
COMPLETED
|
56
|
|
Lavender
NOT COMPLETED
|
0
|
|
Lemon
STARTED
|
56
|
|
Lemon
COMPLETED
|
56
|
|
Lemon
NOT COMPLETED
|
0
|
|
Water (Control)
STARTED
|
56
|
|
Water (Control)
COMPLETED
|
56
|
|
Water (Control)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effects of Smell on Mood and Physical Responses
Baseline characteristics by cohort
| Measure |
Lavender Oil / Lemon Oil / Water Control
n=56 Participants
A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
56 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
24.41 years
STANDARD_DEVIATION 6.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 Visits with at least 2 weeks between each. Average time to complete all visits was 64.46 days (SD 48.4). Cortisol: 9:05, 10:05, 10:55, 11:45, 12:15, 13:00. Nor/Epi: 9:05, 10:05, 10:55, 11:05, 11:45, 12:15Cortisol, norepinephrine, epinephrine measured before and after physical (cold pressor) stressor, which occurred at 11:00.
Outcome measures
| Measure |
Lavender
n=56 Participants
A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
|
Water Control
n=56 Participants
A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
|
Lemon
n=56 Participants
A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
|
|---|---|---|---|
|
Cortisol and Catecholamine Production
Cortisol (post stress)
|
0.107 pg/ml (log 10)
Standard Deviation 0.056
|
0.119 pg/ml (log 10)
Standard Deviation 0.071
|
0.107 pg/ml (log 10)
Standard Deviation 0.056
|
|
Cortisol and Catecholamine Production
Epinephrine (post stress)
|
43.5 pg/ml (log 10)
Standard Deviation 32.7
|
44.3 pg/ml (log 10)
Standard Deviation 24.2
|
38.3 pg/ml (log 10)
Standard Deviation 17.9
|
|
Cortisol and Catecholamine Production
Norepinephrine (Change pre to post stress)
|
0.03 pg/ml (log 10)
Standard Deviation 0.02
|
0.03 pg/ml (log 10)
Standard Deviation 0.01
|
0.073 pg/ml (log 10)
Standard Deviation 0.024
|
PRIMARY outcome
Timeframe: 3 Visits with at least 2 weeks between each. Average time to complete all visits was 64.46 days (SD 48.4). 9:05, 10:05, 11:45Stimulated Cytokine Production (Interleukin-6 (IL-6), Interleukin-10 (IL-10)) measured before and after cold pressor stressor, which occurred at 11:00.
Outcome measures
| Measure |
Lavender
n=56 Participants
A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
|
Water Control
n=56 Participants
A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
|
Lemon
n=56 Participants
A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
|
|---|---|---|---|
|
Immune Function
IL-6
|
3.706 pg/ml
Standard Deviation 0.814
|
3.622 pg/ml
Standard Deviation 0.857
|
3.623 pg/ml
Standard Deviation 0.904
|
|
Immune Function
IL-10
|
1.777 pg/ml
Standard Deviation 0.480
|
1.734 pg/ml
Standard Deviation 0.463
|
1.787 pg/ml
Standard Deviation 0.458
|
PRIMARY outcome
Timeframe: 3 Visits with at least 2 weeks between each. Average time to complete all visits was 64.46 days (SD 48.4).10:05, 11:45, 13:15TEWL (Transepidermal Water Loss, via tape stripping procedure)measured before and after cold pressor stressor (11:00). After obtaining baseline measurements on volar forearm, cellophane tape(3M Scotch-type; St. Paul, MN) was applied repeatedly (6-50 times) to remove superficial layer of cornified skin cells. Tape stripping stopped when TEWL was elevated from the basal level of 5-7 g/h/m2 to at least 20 g/h/m2. The number of strips required to reach TEWL X20 g/m2/h was the measure of barrier. TEWL was measured with a computerized evaporimetry instrument, the DermaLabs (CyberDERM, Media, PA).
Outcome measures
| Measure |
Lavender
n=56 Participants
A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
|
Water Control
n=56 Participants
A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
|
Lemon
n=56 Participants
A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
|
|---|---|---|---|
|
Skin Barrier Repair
Time 1 Pre-Stress
|
23.21 number tape strips
Standard Deviation 11.52
|
24.33 number tape strips
Standard Deviation 10.61
|
22.11 number tape strips
Standard Deviation 10.47
|
|
Skin Barrier Repair
Time 2 Post-Stress
|
15.64 number tape strips
Standard Deviation 4.76
|
17.78 number tape strips
Standard Deviation 7.30
|
16.82 number tape strips
Standard Deviation 6.10
|
PRIMARY outcome
Timeframe: Day 1 11:45, Day 2 (24h) 11:45, Day 3 (48h) 11:45, Day 4 (72h) 11:45.DTH memory responses to a common infectious agent provided a measure of T-cell immunity. Nurses inoculated subject's arm with 0.1ml Candida (stock solution diluted 1:20 in saline, Greer Labs, NC) intradermally, after the cold pressor stressor. The wheal diameter (2 dimensions) was self-assessed at 24, 48, and 72 hours by participants given detailed instructions and templates for measurement.
Outcome measures
| Measure |
Lavender
n=56 Participants
A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
|
Water Control
n=56 Participants
A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
|
Lemon
n=56 Participants
A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
|
|---|---|---|---|
|
Immune Function: Delayed Hypersensitivity to Candida(DTH)
|
10.84 mm^2
Standard Deviation 10.01
|
17.39 mm^2
Standard Deviation 15.08
|
12.40 mm^2
Standard Deviation 10.12
|
Adverse Events
Lavender Oil / Lemon Oil / Water Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Janice K. Kiecolt-Glaser, PhD
The Ohio State University, Department of Psychiatry
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place