InflammationPhase 2NCT00385723

Fish Oil (Omega 3), Immune Function, and Mood

A Phase 2 study testing Omega 3 (Fish Oil) Supplementation in people with Inflammation, run by Ohio State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is designed to examine the effects of fish oil on immune function and mood. Read more about this study

Who is it for?: Ages 40 to 88 yearsHealthy volunteers can take part
Conditions the study is for: Inflammation
What is being tested?: Omega 3 (Fish Oil) Supplementation
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 138 participants
Where: 1 siteUnited States
Study dates: Sep 2006to Feb 2011
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 40 to 88 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy men and women
NOT currently taking any sort of fish oil or omega 3 supplement

Who cannot join

Use of blood pressure medicines, cholesterol-lowering drugs, steroids, or antidepressants
Certain lifestyle habits such as smoking or exercising vigorously for 2 or more hours a week may also exclude applicants from participating

Trial locations and contacts

1 site in 1 country.

United States1 site

The Ohio State University
Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Omega-3 Dietary Supplementation, Immune Function, and Mood

This study is designed to examine the effects of fish oil on immune function and mood.

Read the detailed description

The beneficial effects of fish oil (or eating fish more frequently) include reductions in triglycerides, blood pressure, and heart rate, as well as increases in HDL cholesterol, the "good" type of cholesterol. In addition, certain aspects of immune function also appear to show favorable responses to fish oil supplementation, and some studies suggest that fish oil helps to improve mood and decrease depression.

This study is designed to examine how supplementation with omega-3 polyunsaturated fatty acids (key fish oil components) affects aspects of your immune response, and your mood; because some research suggests that people who eat more fish may do better during stressful times, the study will also examine how fish oil affects your immune response to stress, certain stress hormone responses, and your psychological response to stress.

For detailed information about the study, please visit our website at http://www.stressandhealth.org

Conditions: Inflammation
Being tested: Omega 3 (Fish Oil) Supplementation, 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 (Fish Oil) SupplementationDietary supplement
1.25 g or 2.496 g daily for 4 months
PlaceboDietary supplement
matching placebo capsule daily for 4 months

Study groups in NCT00385723
Study group	Role	What they receive
1	Experimental	1.25 g/d Receives: Dietary Supplement: Omega 3 (Fish Oil) Supplementation
2	Experimental	2.496 g/d Receives: Dietary Supplement: Omega 3 (Fish Oil) Supplementation
3	Placebo comparator	Not described Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Serum ln(TNF-a)
log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha)
Measured: Baseline & 4 months
Serum ln(IL-6)
log-transformed serum Interleukin-6 (IL-6)
Measured: Baseline & 4 months
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: Baseline & 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2006Feb 2011

First posted11 Oct 2006 (estimated)
Study startSep 2006
Primary completionFeb 2011
Study completionFeb 2011

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 (4)Papers the sponsor has linked to this study.
Other trials for InflammationStudies of the same condition, open and under way.
More trials run by Ohio State UniversityThe sponsor's other registered studies.
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, Investigator, Outcomes assessor
Enrolment: 138 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00385723
Sponsor's protocol ID: AG0087
Other IDs: 2006H0054, R01AG029562
Status last verified: Nov 2012
First submitted: 10 Oct 2006
Last updated: 20 Nov 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Kiecolt-Glaser JK, Belury MA, Andridge R, Malarkey WB, Hwang BS, Glaser R. Omega-3 supplementation lowers inflammation in healthy middle-aged and older adults: a randomized controlled trial. Brain Behav Immun. 2012 Aug;26(6):988-95. doi: 10.1016/j.bbi.2012.05.011. Epub 2012 May 26.
PubMed 22640930
Kiecolt-Glaser JK, Epel ES, Belury MA, Andridge R, Lin J, Glaser R, Malarkey WB, Hwang BS, Blackburn E. Omega-3 fatty acids, oxidative stress, and leukocyte telomere length: A randomized controlled trial. Brain Behav Immun. 2013 Feb;28:16-24. doi: 10.1016/j.bbi.2012.09.004. Epub 2012 Sep 23.
PubMed 23010452
Madison AA, Belury MA, Andridge R, Renna ME, Rosie Shrout M, Malarkey WB, Lin J, Epel ES, Kiecolt-Glaser JK. Omega-3 supplementation and stress reactivity of cellular aging biomarkers: an ancillary substudy of a randomized, controlled trial in midlife adults. Mol Psychiatry. 2021 Jul;26(7):3034-3042. doi: 10.1038/s41380-021-01077-2. Epub 2021 Apr 20.
PubMed 33875799
Jaremka LM, Derry HM, Bornstein R, Prakash RS, Peng J, Belury MA, Andridge RR, Malarkey WB, Kiecolt-Glaser JK. Omega-3 supplementation and loneliness-related memory problems: secondary analyses of a randomized controlled trial. Psychosom Med. 2014 Oct;76(8):650-8. doi: 10.1097/PSY.0000000000000104.
PubMed 25264972

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Omega-3 Dietary Supplementation, Immune Function, and Mood
ClinicalTrials.gov ID: NCT00385723
Acronym / sponsor ID: AG0087
Conditions: Inflammation
Keywords: affect, inflammation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 138 participants (actual)
Lead sponsor: Ohio State UniversityUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: Sep 2006
Primary completion: Feb 2011 (actual)
Study completion: Feb 2011 (actual)
First posted: 11 Oct 2006 (estimated)
Results: Posted 8 Nov 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.

Detailed description

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, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Dietary Supplement: Omega 3 (Fish Oil) Supplementation1.25 g/d
2	Experimental	Dietary Supplement: Omega 3 (Fish Oil) Supplementation2.496 g/d
3	Placebo comparator	Dietary Supplement: Placebo

Who may qualify

Ages: 40 to 88 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Healthy men and women
NOT currently taking any sort of fish oil or omega 3 supplement

Key exclusion criteria (2 listed)

Use of blood pressure medicines, cholesterol-lowering drugs, steroids, or antidepressants
Certain lifestyle habits such as smoking or exercising vigorously for 2 or more hours a week may also exclude applicants from participating

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 (Fish Oil) Supplementation1.25 g or 2.496 g daily for 4 months	Dietary supplement	1, 2
Placebomatching placebo capsule daily for 4 months	Dietary supplement	3

Primary outcome

Serum ln(TNF-a)
Time frame: Baseline & 4 months
log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha)
Serum ln(IL-6)
Time frame: Baseline & 4 months
log-transformed serum Interleukin-6 (IL-6)
ln(CES-D)
Time frame: Baseline & 4 months
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.

Results and safety

Results posted to the registry on 8 Nov 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	46	44
1.25 g/d n-3	46	45
2.5 g/d n-3	46	44

Primary outcome: Serum ln(TNF-a)

Time frame: Baseline & 4 months. Least squares mean (Standard Error). Unit: pg/ml (raw TNF-a)

Measure	Placebo n = 46	1.25 g/d n-3 n = 46	2.5 g/d n-3 n = 46
Baseline (visit 1)	0.66 (0.25)	0.74 (0.25)	0.71 (0.25)
Change, Visit 1 to 5	0.11 (0.030)	0.002 (0.028)	-0.024 (0.029)

Placebo vs 1.25 g/d n-3: Difference in change from baseline: -0.11 (95% CI -0.19 to -0.028), p = 0.03, Mixed Models Analysis
Placebo vs 2.5 g/d n-3: Difference in change from baseline: -0.13 (95% CI -0.22 to -0.052), p = 0.004, Mixed Models Analysis

Population analysed: intention to treat

Primary outcome: Serum ln(IL-6)

Time frame: Baseline & 4 months. Least squares mean (Standard Error). Unit: pg/ml (raw IL-6)

Measure	Placebo n = 46	1.25 g/d n-3 n = 46	2.5 g/d n-3 n = 46
Baseline (visit 1)	0.91 (0.60)	1.02 (0.60)	0.85 (0.60)
Change, Visit 1 to 5	0.31 (0.077)	-0.106 (0.070)	-0.123 (0.074)

Placebo vs 1.25 g/d n-3: Difference in change from baseline: -0.41 (95% CI -0.62 to -0.21), p = 0.0003, Mixed Models Analysis
Placebo vs 2.5 g/d n-3: Difference in change from baseline: -0.43 (95% CI -0.64 to -0.22), p = 0.0002, Mixed Models Analysis

Population analysed: intention to treat

Primary outcome: ln(CES-D)

Time frame: Baseline & 4 months. Least squares mean (Standard Error). Unit: scores on a scale

Measure	Placebo n = 46	1.25 g/d n-3 n = 46	2.5 g/d n-3 n = 46
Baseline (visit 1)	1.5 (0.17)	1.5 (0.17)	1.6 (0.17)
Change, visit 1 to 5	-0.056 (0.15)	-0.29 (0.15)	-0.26 (0.15)

Placebo vs 1.25 g/d n-3: Difference in change from baseline: -0.23 (95% CI -0.64 to 0.18), p = 0.80, Mixed Models Analysis
Placebo vs 2.5 g/d n-3: Difference in change from baseline: -0.20 (95% CI -0.61 to 0.21), p = 1.0, Mixed Models Analysis

Population analysed: intention to treat

Adverse events

Time frame: 4 months. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 46 (0%)	42 of 46 (91.3%)	Not reported
1.25 g/d n-3	0 of 46 (0%)	38 of 46 (82.6%)	Not reported
2.5 g/d n-3	0 of 46 (0%)	40 of 46 (87%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22640930Kiecolt-Glaser JK, Belury MA, Andridge R, Malarkey WB, Hwang BS, Glaser R. Omega-3 supplementation lowers inflammation in healthy middle-aged and older adults: a randomized controlled trial. Brain Behav Immun. 2012 Aug;26(6):988-95. doi: 10.1016/j.bbi.2012.05.011. Epub 2012 May 26.
Results publication: PubMed 23010452Kiecolt-Glaser JK, Epel ES, Belury MA, Andridge R, Lin J, Glaser R, Malarkey WB, Hwang BS, Blackburn E. Omega-3 fatty acids, oxidative stress, and leukocyte telomere length: A randomized controlled trial. Brain Behav Immun. 2013 Feb;28:16-24. doi: 10.1016/j.bbi.2012.09.004. Epub 2012 Sep 23.
Derived from this study: PubMed 33875799Madison AA, Belury MA, Andridge R, Renna ME, Rosie Shrout M, Malarkey WB, Lin J, Epel ES, Kiecolt-Glaser JK. Omega-3 supplementation and stress reactivity of cellular aging biomarkers: an ancillary substudy of a randomized, controlled trial in midlife adults. Mol Psychiatry. 2021 Jul;26(7):3034-3042. doi: 10.1038/s41380-021-01077-2. Epub 2021 Apr 20.
Derived from this study: PubMed 25264972Jaremka LM, Derry HM, Bornstein R, Prakash RS, Peng J, Belury MA, Andridge RR, Malarkey WB, Kiecolt-Glaser JK. Omega-3 supplementation and loneliness-related memory problems: secondary analyses of a randomized controlled trial. Psychosom Med. 2014 Oct;76(8):650-8. doi: 10.1097/PSY.0000000000000104.
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 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 (Fish Oil) Supplementation in people with Inflammation, run by Ohio State University 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 2 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 20 Nov 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 8 Nov 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(TNF-a) (time frame: Baseline & 4 months). The study lists 3 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 NCT00385723, which also lists 4 linked publications.

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 20 Nov 2012.