Fish Oil T Cell Function

NCT ID: NCT02775084

Last Updated: 2019-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-04-30

Brief Summary

The purpose of the study is to examine the effect of dietary n-3 polyunsaturated fatty acid supplementation on subjects' pan CD4+ T cell function, cognition, and muscle function. Half of the participants will receive fish oil, while the other half will receive a placebo (olive oil).

Detailed Description

Generalized inflammation has been consistently associated with aging and metabolic diseases, often characterized by reduced muscle and cognitive function. Although much of the aging-associated inflammation has been attributed to chronic activation of the innate host defense system, activated CD4+ T cells have been shown to contribute directly to the pathogenesis of several other inflammatory diseases. In humans, dietary n-3 polyunsaturated fatty acids (PUFA), particularly docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), have anti-inflammatory properties and reduce disease symptoms, in part, through suppression of CD4+ T cell activation. Therefore, the Researchers' overall hypothesis is that dietary supplementation with DHA and EPA in humans will ameliorate inflammatory symptoms, in part, by suppressing CD4+ T cell activation, positively affecting muscle and cognitive function.

Conditions

Muscle Strength; Cognitive Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Healthy Fish Oil

8 grams fish oil

Group Type: EXPERIMENTAL

Fish Oil

Intervention Type: DIETARY_SUPPLEMENT

4 capsules twice daily with food for 6 weeks

Olive Oil

8 grams olive oil

Group Type: PLACEBO_COMPARATOR

Olive Oil

Intervention Type: DIETARY_SUPPLEMENT

4 capsules twice daily with food for 6 weeks

Interventions

Fish Oil

4 capsules twice daily with food for 6 weeks

Intervention Type: DIETARY_SUPPLEMENT

Olive Oil

4 capsules twice daily with food for 6 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Healthy male or female according to the investigator/appointed staff judgment

2. 55 years and older

3. Stable body weight for the past 3 months (< 5% change)

Exclusion Criteria

1. History of cardiovascular disease

2. Metabolic diseases, including hepatic or renal disorders

3. Presence of acute illness or metabolically unstable chronic illness (including diagnosis of Insulin Dependent Diabetes Mellitus)

4. Unwilling to stop taking nutritional supplements containing proteins or free amino acids within 5 days of the first study day until study completion

5. Participated in a nutritional supplement study program within the past 4 weeks

6. Any other condition according to the PI or nurse that would interfere with the study or safety of the subject or influence the results

7. Daily use of supplements containing > 1000 mg EPA+DHA 3 months prior to the first test day

8. Known hypersensitivity to fish and/or shellfish, Swanson EFAs Super EPA Fish oil or any of its ingredients, Swanson EFAs Certified Organic Extra Virgin Olive oil or any of its ingredients

9. Presence of fever within the last 3 days

10. Failure to give informed consent

11. (Possible) Pregnancy

12. Unwilling to comply with any other rules set forth in the Informed Consent Form

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Texas A&M University

OTHER

Sponsor Role: lead

Responsible Party

Marielle PKJ Engelen, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marielle Engelen

Role: PRINCIPAL_INVESTIGATOR

Texas A&M University

Locations

Texas A&M University-CTRAL

College Station, Texas, United States

Countries

United States

Other Identifiers

IRB2015-0691

Identifier Type: -

Identifier Source: org_study_id