NCT00385723

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 11, 2006

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

November 8, 2012

Completed
Last Updated

November 20, 2012

Status Verified

November 1, 2012

Enrollment Period

4.4 years

First QC Date

October 10, 2006

Results QC Date

August 28, 2012

Last Update Submit

November 13, 2012

Conditions

Inflammation

Keywords

affectinflammation

Outcome Measures

Primary Outcomes (3)

  • Serum ln(TNF-a)

    log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha)

    Baseline & 4 months

  • Serum ln(IL-6)

    log-transformed serum Interleukin-6 (IL-6)

    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.

    Baseline & 4 months

Study Arms (3)

1

EXPERIMENTAL

1.25 g/d

Dietary Supplement: Omega 3 (Fish Oil) Supplementation

2

EXPERIMENTAL

2.496 g/d

Dietary Supplement: Omega 3 (Fish Oil) Supplementation

3

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Omega 3 (Fish Oil) SupplementationDIETARY_SUPPLEMENT

1.25 g or 2.496 g daily for 4 months

12
PlaceboDIETARY_SUPPLEMENT

matching placebo capsule daily for 4 months

3

Eligibility Criteria

Age40 Years - 88 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (4)

  • 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.

    PMID: 22640930RESULT

  • 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.

    PMID: 23010452RESULT

  • 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.

    PMID: 33875799DERIVED

  • 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.

    PMID: 25264972DERIVED

Related Links

MeSH Terms

Conditions

Inflammation

Interventions

Docosahexaenoic AcidsFish OilsDietary Supplements

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
Dr. Janice K. Kiecolt-Glaser
Organization
Institute for Behavioral Medicine Research, Ohio State University College of Medicine, OH, USA
Janice.Kiecolt-Glaser@osumc.edu
+1 614 293 3499

Study Officials

  • Janice K. Kiecolt-Glaser

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry and Psychology

Study Record Dates

First Submitted

October 10, 2006

First Posted

October 11, 2006

Study Start

September 1, 2006

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

November 20, 2012

Results First Posted

November 8, 2012

Record last verified: 2012-11

Locations

US(1)