Inflammation
Conditions
Keywords
Immune system, Social psychology, Health psychology
Brief summary
UCLA researchers looking for healthy individuals (age 45-60) to participate in a study investigating whether an anti-inflammatory medication can impact daily life experiences. Everyday for two weeks, participants will take either an anti-inflammatory medication (naproxen) twice daily, or a placebo pill twice daily. Participants will also answer daily questions during the 2-week period. Participants will also fill out questionnaires and complete a few tasks on the computer: once prior to the 2-week period and once immediately after the 2-week period, both during online study sessions.
Detailed description
Participants (ntotal=50) will be men and women, ages 45-60. All interested participants will first complete a structured telephone interview in order to assess eligibility. The study will begin with filling out questionnaires, as well as an online session to complete some tasks. You will then be randomly assigned to take either an anti-inflammatory medication (naproxen) or placebo (inactive substance) to take twice daily everyday for the following two weeks. You will also be contacted by text message to remind you to take your pills, to ask if you have taken your pills, and to send you a link to fill out questionnaires once daily. After the two weeks are over, you will again complete questionnaires and the online study session with tasks. Finally, two weeks after the second session, you will receive an email to fill out questionnaires online.
Interventions
DRUGNaproxen
Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)
DRUGPlacebos
Half of the participants will be randomly assigned to receive a placebo pill twice daily
Sponsors
National Institute on Aging (NIA)
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy adults 45-60
Exclusion criteria
Following a structured telephone interview, participants with the following conditions will not be able to participate: * certain active, uncontrolled medical disorders * use of certain medications (e.g., hypnotic and psychotropic medication, steroid use, opioid use) * psychiatric disorders (e.g., current major depression, bipolar disorder) Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Loneliness | T1: Baseline, T2: post-intervention (2 weeks later) | Changes in self-report measures of loneliness (University of California, Los Angeles (UCLA) Loneliness Scale) Scale ranges from 20-80 (though participants were included based on higher levels of loneliness, \> 41). Higher values represent higher levels of loneliness. |
| Negative Picture Viewing Task | T1: Baseline, T2: post-intervention (2 weeks later) | Changes in ratings of negative pictures To what extent is this picture positive or negative: from -5 (very negative) to +5 (very positive) Lower scores indicate more negativity |
| Social Reward Task | T1: Baseline, T2: post-intervention (2 weeks later) | Changes in reaction time to close others vs. control image (measures in seconds) Faster reaction times indicate greater sensitivity; so lower scores (fewer seconds) indicate greater sensitivity to close others vs. control images |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Gene Expression | T1: Baseline, T2: post-intervention (2 weeks later) | Changes in inflammatory gene expression Values are the logged transformed values of a pre-specified composite of 19 representative proinflammatory genes (e.g., IL1B, IL6, COX2/PTGS2,TNF). Composite is in counts per million. Final scale is the logged value of this counts per million (logCPM). Higher numbers indicate greater inflammatory gene expression |
| Loneliness at Follow-up (2 Weeks Post-intervention) | T3: 2 weeks after the end of the intervention (4 weeks after the start of the intervention) | Changes in self-report measures of loneliness (University of California, Los Angeles (UCLA) Loneliness Scale) at follow-up, 2 weeks after the end of the intervention Scale ranges from 20-80 (though participants were included based on higher levels of loneliness, \> 41). Higher values represent higher levels of loneliness. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Naproxen Naproxen: Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day) | 41 |
| Placebo Placebos: Half of the participants will be randomly assigned to receive a placebo pill twice daily | 43 |
| Total | 84 |
Baseline characteristics
| Characteristic | Naproxen | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants | 43 Participants | 84 Participants |
| Age, Continuous | 51.9 years STANDARD_DEVIATION 4.94 | 51.9 years STANDARD_DEVIATION 5.11 | 51.9 years STANDARD_DEVIATION 5 |
| Race/Ethnicity, Customized Ethnicity/Race Asian | 4 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Ethnicity/Race Black | 7 Participants | 5 Participants | 12 Participants |
| Race/Ethnicity, Customized Ethnicity/Race Hispanic/Latino | 11 Participants | 5 Participants | 16 Participants |
| Race/Ethnicity, Customized Ethnicity/Race Middle Eastern | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Ethnicity/Race White | 19 Participants | 28 Participants | 47 Participants |
| Region of Enrollment United States | 41 participants | 43 participants | 84 participants |
| Sex: Female, Male Female | 29 Participants | 31 Participants | 60 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 43 |
| other Total, other adverse events | 0 / 41 | 0 / 43 |
| serious Total, serious adverse events | 0 / 41 | 0 / 43 |
Outcome results
Primary
Loneliness
Changes in self-report measures of loneliness (University of California, Los Angeles (UCLA) Loneliness Scale) Scale ranges from 20-80 (though participants were included based on higher levels of loneliness, \> 41). Higher values represent higher levels of loneliness.
Time frame: T1: Baseline, T2: post-intervention (2 weeks later)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naproxen | Loneliness | T1 Loneliness | 47.9 score on a scale | Standard Deviation 10 |
| Naproxen | Loneliness | T2 Loneliness | 46.8 score on a scale | Standard Deviation 9.43 |
| Placebo | Loneliness | T1 Loneliness | 46.9 score on a scale | Standard Deviation 10.5 |
| Placebo | Loneliness | T2 Loneliness | 44.6 score on a scale | Standard Deviation 10.5 |
Primary
Negative Picture Viewing Task
Changes in ratings of negative pictures To what extent is this picture positive or negative: from -5 (very negative) to +5 (very positive) Lower scores indicate more negativity
Time frame: T1: Baseline, T2: post-intervention (2 weeks later)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naproxen | Negative Picture Viewing Task | T1 Ratings of Pictures | -2.83 score on a scale | Standard Deviation 1.58 |
| Naproxen | Negative Picture Viewing Task | T2 Ratings of Pictures | -2.90 score on a scale | Standard Deviation 1.61 |
| Placebo | Negative Picture Viewing Task | T1 Ratings of Pictures | -2.60 score on a scale | Standard Deviation 1.59 |
| Placebo | Negative Picture Viewing Task | T2 Ratings of Pictures | -2.66 score on a scale | Standard Deviation 1.51 |
Primary
Social Reward Task
Changes in reaction time to close others vs. control image (measures in seconds) Faster reaction times indicate greater sensitivity; so lower scores (fewer seconds) indicate greater sensitivity to close others vs. control images
Time frame: T1: Baseline, T2: post-intervention (2 weeks later)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naproxen | Social Reward Task | T2 RT to close other vs. control | -.020 seconds | Standard Deviation 0.112 |
| Naproxen | Social Reward Task | T1 RT to close other vs. control | -0.012 seconds | Standard Deviation 0.056 |
| Placebo | Social Reward Task | T1 RT to close other vs. control | -.003 seconds | Standard Deviation 0.025 |
| Placebo | Social Reward Task | T2 RT to close other vs. control | .002 seconds | Standard Deviation 0.054 |
Secondary
Inflammatory Gene Expression
Changes in inflammatory gene expression Values are the logged transformed values of a pre-specified composite of 19 representative proinflammatory genes (e.g., IL1B, IL6, COX2/PTGS2,TNF). Composite is in counts per million. Final scale is the logged value of this counts per million (logCPM). Higher numbers indicate greater inflammatory gene expression
Time frame: T1: Baseline, T2: post-intervention (2 weeks later)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naproxen | Inflammatory Gene Expression | T1 Inflammatory Composite | .070 logCPM | Standard Deviation 0.352 |
| Naproxen | Inflammatory Gene Expression | T2 Inflammatory Composite | .042 logCPM | Standard Deviation 0.292 |
| Placebo | Inflammatory Gene Expression | T1 Inflammatory Composite | .057 logCPM | Standard Deviation 0.357 |
| Placebo | Inflammatory Gene Expression | T2 Inflammatory Composite | .001 logCPM | Standard Deviation 0.345 |
Secondary
Loneliness at Follow-up (2 Weeks Post-intervention)
Changes in self-report measures of loneliness (University of California, Los Angeles (UCLA) Loneliness Scale) at follow-up, 2 weeks after the end of the intervention Scale ranges from 20-80 (though participants were included based on higher levels of loneliness, \> 41). Higher values represent higher levels of loneliness.
Time frame: T3: 2 weeks after the end of the intervention (4 weeks after the start of the intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Naproxen | Loneliness at Follow-up (2 Weeks Post-intervention) | 45.1 score on a scale | Standard Deviation 10.7 |
| Placebo | Loneliness at Follow-up (2 Weeks Post-intervention) | 43.5 score on a scale | Standard Deviation 10.8 |