Fish Oil T Cell Function

Nutritional Intervention to Test Effect on Healthy Human T Cell Function

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).

Study Overview

• Status: Completed
• Conditions: Cognitive Function; Muscle Strength
• Intervention / Treatment: Dietary supplement: Fish Oil; Dietary supplement: 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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • College Station, Texas, United States, 77843
      • Texas A&M University-CTRAL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Fish Oil; 8 grams fish oil	Dietary supplement: Fish Oil; 4 capsules twice daily with food for 6 weeks
Placebo Comparator: Olive Oil; 8 grams olive oil	Dietary supplement: Olive Oil; 4 capsules twice daily with food for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in function of of lipid rafts in immune cell membranes due to dietary polyunsaturated fatty acids supplementation	one blood draw on each study visit	one time on baseline, day 21 and day 42

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatty acid metabolism	One blood draw on each study visit	one time on baseline, day 21 and day 42
Skeletal muscle strength of hand	Measurement of hand grip strength	30 minutes on baseline, day 21 and day 42
Skeletal muscle strength of leg	Measurement of muscle strength of leg using kin-com machine	30 minutes on baseline, day 21 and day 42
Body Composition	Body composition as measured by Dual-Energy X-ray Absorptiometry	15 minutes on baseline, day 21 and day 42
Group differences in state of mood as measured by the Hospital Anxiety and Depression Scale (HADS	A fourteen item self-assessment scale. Seven of the items related to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression.	Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42
Diet recall	The subject is asked to recall in detail all the food and drink consumed during the 24 hours prior to the test day.	on baseline and change from day 21 and day 42
Group differences in attention and executive functions as measured by Stroop Color-Word Test (SCWT)	A word page with words printed in black ink, a color page with blocks printed in color, and a color-word page where the color and the word do not match. The examinee reads the words or names the ink colors as quickly as possible within a time limit. Measures selective attention and inhibitory control. The total time in seconds was reported for each trial.	Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42
Group differences in attention and executive functions as measured by Trail Making Test (TMT)	In Part A, the examinee is instructed to connect a set of 25 circles with numbers as quickly as possible while maintaining accuracy. In Part B, the examinee is instructed to connect a set of 25 circles, alternating between numbers and letters, as quickly as possible while maintaining accuracy. Measures attentional resources and is a measure of the frontal lobe "executive" functions of visual search, set-switching and mental flexibility. The total time in seconds was reported for each measure.	Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42
Group differences in learning and memory as measured by Digit Span	Recall of numbers in the same order (Digit Forward) and in reverse order (Digit Backward). Measures auditory attention and verbal working memory.	Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42
Group differences in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)	Assesses several cognitive domains and is used for the screening of mild cognitive impairment. Total scores range from 0-30 with lower scores indicating decreased functioning.	Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42
Executive Function-Adolescent/Adult Sensory Profile (ASP)	A standardized self-questionnaire that generates an individualized profile of sensory processing across four quadrants: low registration, sensation seeking, sensory sensitivity, and sensation avoiding.	Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42
Group differences in attention and executive functions as measured by Brief-A	A standardized self-report that captures views of an adult's executive functions or self-regulation in his or her everyday environment.	Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42

Collaborators and Investigators

• Sponsor: Texas A&M University
• Investigators: Principal Investigator: Marielle Engelen, Texas A&M University

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: May 10, 2016
• First Submitted That Met QC Criteria: May 13, 2016
• First Posted (Estimate): May 17, 2016

Study Record Updates

• Last Update Posted (Actual): April 22, 2019
• Last Update Submitted That Met QC Criteria: April 19, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Cognition; Antigens; Fatty acids; CD4; n-3; Polyunsaturated
• Other Study ID Numbers: IRB2015-0691

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO