Stress-related Changes in InflammationPhase 2NCT00519779
Academic Stress and Proinflammatory Cytokines: Omega-3 Intervention
A Phase 2 study testing omega-3 supplementation in people with Stress-related Changes in Inflammation, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
This study is designed to examine the effects of fish oil on immune function and mood in medical students. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress-related Changes in Inflammation
- What is being tested?
- omega-3 supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Dec 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- OSU preclinical medical or dental student, or graduate nursing student
- male or female
Who cannot join
- taking certain medications with immune or endocrine effects
- chronic health conditions
- smoking
- excessive use of alcohol or caffeine
- significant digestive problems
- routine use of fish oil or flaxseed supplements or high fish intake
- fish allergy
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University College of Medicine
Columbus, Ohio, 43210
About this study
This study is designed to examine the effects of fish oil on immune function and mood in medical students.
Read the detailed description
This study will examine how supplementation with omega-3 polyunsaturated fatty acids (key fish oil components) affects immune and mood responses to examination stress. This study will examine these outcomes in medical students during academic examination periods as well as less stressful non-exam periods. Participants will take fish oil supplements or placebo pills for approximately 3 months during which time relevant mood, endocrine, and immune measures will be assessed.
For detailed information about the study, please visit our website at http://www.stressandhealth.org
- Conditions
- Stress-related Changes in Inflammation
- Being tested
- omega-3 supplementation, Oral omega-3 fish oil placebo
- Keywords
- affect, inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3 supplementationDietary supplement
2.5 g/day omega-3
Oral omega-3 fish oil placeboDietary supplement
to match experimental dosage
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | Placebo oral Omega-3 fish oil supplementation Receives: Dietary Supplement: Oral omega-3 fish oil placebo |
| 1 | Experimental | oral Omega-3 fish oil supplementation Receives: Dietary Supplement: omega-3 supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum ln(IL-6)
log-transformed serum Interleukin-6 (IL-6)
Serum cytokine levels provide an assessment of systemic inflammation, the cytokine level circulating throughout the body. Higher levels are typically interrupted as worse unless an individual is acutely ill.
Stimulated cytokine production reflects the inflammatory cytokine production capacity of monocytes.
Measured: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
Serum ln(TNF-a)
log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha)
All cytokine measurements (e.g., IL-6 and TNF-a, serum and stimulated) were analyzed across time; however, no stress effects were found. Therefore, all assessments post-supplementation were averaged (time points 3-6) and analyzed to determine whether fish oil supplementation had an effect. Pooling these 4 assessments provides a better estimate of an individual's cytokine levels because single time point measurements can be affected by changes in exercise, alcohol consumption, or sleep in the preceding 24-48 hours.
Measured: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
Stimulated ln(IL-6)
log-transformed stimulated IL-6
Serum cytokine levels provide an assessment of systemic inflammation, the cytokine level circulating throughout the body. Higher levels are typically interrupted as worse unless an individual is acutely ill.
Stimulated cytokine production reflects the inflammatory cytokine production capacity of monocytes.
Measured: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
Stimulated ln(TNF-alpha)
log-transformed stimulated TNF-alpha
Measured: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
Secondary outcomes (2)
ln(Beck Anxiety Score)
log-transformed Beck anxiety score, min-max values - 0-4.1: higher means greater anxiety
Measured: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
ln(CES-D)
log-transformed Center for Epidemiologic Studies Depression Scale (CES-D) score
The CES-D is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale.
Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms.
Measured: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionDec 2008
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress-related Changes in InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Office of Dietary Supplements (ODS)
- Responsible party
- Principal investigator, Janice Kiecolt-Glaser, National Center for Complementary and Integrative Health (NCCIH)
- Investigators
- Janice K Kiecolt-Glaser, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519779
- Sponsor's protocol ID
- R21AT003912-01A1
- Other IDs
- AT003912
- Status last verified
- Feb 2012
- First submitted
- 21 Aug 2007
- Last updated
- 27 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kiecolt-Glaser JK, Belury MA, Andridge R, Malarkey WB, Glaser R. Omega-3 supplementation lowers inflammation and anxiety in medical students: a randomized controlled trial. Brain Behav Immun. 2011 Nov;25(8):1725-34. doi: 10.1016/j.bbi.2011.07.229. Epub 2011 Jul 19.
PubMed 21784145
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Academic Stress and Proinflammatory Cytokines: Omega-3 Intervention
- ClinicalTrials.gov ID
- NCT00519779
- Acronym / sponsor ID
- R21AT003912-01A1
- Conditions
- Stress-related Changes in Inflammation
- Keywords
- affect, inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Collaborators
- Office of Dietary Supplements (ODS)
- Study start
- Jul 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 23 Aug 2007 (estimated)
- Results
- Posted 22 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to examine the effects of fish oil on immune function and mood in medical students.
Detailed description
This study will examine how supplementation with omega-3 polyunsaturated fatty acids (key fish oil components) affects immune and mood responses to examination stress. This study will examine these outcomes in medical students during academic examination periods as well as less stressful non-exam periods. Participants will take fish oil supplements or placebo pills for approximately 3 months during which time relevant mood, endocrine, and immune measures will be assessed.
For detailed information about the study, please visit our website at http://www.stressandhealth.org
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Dietary Supplement: Oral omega-3 fish oil placeboPlacebo oral Omega-3 fish oil supplementation |
| 1 | Experimental | Dietary Supplement: omega-3 supplementationoral Omega-3 fish oil supplementation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- OSU preclinical medical or dental student, or graduate nursing student
- male or female
Key exclusion criteria (7 listed)
- taking certain medications with immune or endocrine effects
- chronic health conditions
- smoking
- excessive use of alcohol or caffeine
- significant digestive problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omega-3 supplementation2.5 g/day omega-3 | Dietary supplement | 1 |
| Oral omega-3 fish oil placeboto match experimental dosage | Dietary supplement | 2 |
Primary outcome
Serum ln(IL-6)
Time frame: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
log-transformed serum Interleukin-6 (IL-6) Serum cytokine levels provide an assessment of systemic inflammation, the cytokine level circulating throughout the body. Higher levels are typically interrupted as worse unless an individual is acutely ill. Stimulated cytokine production reflects the inflammatory cytokine production capacity of monocytes.
Serum ln(TNF-a)
Time frame: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha) All cytokine measurements (e.g., IL-6 and TNF-a, serum and stimulated) were analyzed across time; however, no stress effects were found. Therefore, all assessments post-supplementation were averaged (time points 3-6) and analyzed to determine whether fish oil supplementation had an effect. Pooling these 4 assessments provides a better estimate of an individual's cytokine levels because single time point measurements can be affected by changes in exercise, alcohol consumption, or sleep in the preceding 24-48 hours.
Stimulated ln(IL-6)
Time frame: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
log-transformed stimulated IL-6 Serum cytokine levels provide an assessment of systemic inflammation, the cytokine level circulating throughout the body. Higher levels are typically interrupted as worse unless an individual is acutely ill. Stimulated cytokine production reflects the inflammatory cytokine production capacity of monocytes.
Stimulated ln(TNF-alpha)
Time frame: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
log-transformed stimulated TNF-alpha
2 secondary outcomes
ln(Beck Anxiety Score)
Time frame: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
ln(CES-D)
Time frame: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21784145Kiecolt-Glaser JK, Belury MA, Andridge R, Malarkey WB, Glaser R. Omega-3 supplementation lowers inflammation and anxiety in medical students: a randomized controlled trial. Brain Behav Immun. 2011 Nov;25(8):1725-34. doi: 10.1016/j.bbi.2011.07.229. Epub 2011 Jul 19.
- Please click here to visit our website if you would like to read more about the study or apply to participate.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice K Kiecolt-Glaser, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing omega-3 supplementation in people with Stress-related Changes in Inflammation, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum ln(IL-6) (time frame: every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00519779, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2012.