Academic Stress and Proinflammatory Cytokines: Omega-3 Intervention

NCT00519779 | Completed Phase 2 Results

• 2 other identifiers: R21AT003912-01A1AT003912
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stress-related Changes in Inflammation

Keywords

affect; inflammation

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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

  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)

  every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)

• ln(CES-D)

  every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)

Study Arms (2)

2

PLACEBO COMPARATOR

Placebo oral Omega-3 fish oil supplementation

Dietary Supplement: Oral omega-3 fish oil placebo

1

EXPERIMENTAL

oral Omega-3 fish oil supplementation

Dietary Supplement: omega-3 supplementation

Interventions

omega-3 supplementation DIETARY_SUPPLEMENT

2.5 g/day omega-3

1

Oral omega-3 fish oil placebo DIETARY_SUPPLEMENT

to match experimental dosage

2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• OSU preclinical medical or dental student, or graduate nursing student
• male or female

You may not qualify if:

• 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

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): lead
• Office of Dietary Supplements (ODS): collaborator

Study Sites (1)

The Ohio State University College of Medicine

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• 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.

  PMID: 21784145 RESULT

Related Links

• Please click here to visit our website if you would like to read more about the study or apply to participate.

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Janice Kiecolt-Glaser
• Organization: The Ohio State University

Janice.Kiecolt-Glaser@osumc.edu

614-293-3499

Study Officials

• Janice K Kiecolt-Glaser, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 21, 2007
• First Posted: August 23, 2007
• Study Start: July 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2010
• Last Updated: March 27, 2012
• Results First Posted: March 22, 2012

Record last verified: 2012-02

Locations

US (1)