Fish Oil T Cell Function

Study Overview
=================
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.

Official Title
-----------------
Nutritional Intervention to Test Effect on Healthy Human T Cell Function

Conditions
-----------------
Muscle Strength, Cognitive Function

Intervention / Treatment
-----------------
* Dietary Supplement: Fish Oil
* Dietary Supplement: Olive Oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Healthy male or female according to the investigator/appointed staff judgment 55 years and older Stable body weight for the past 3 months (< 5% change) Exclusion criteria: History of cardiovascular disease Metabolic diseases, including hepatic or renal disorders Presence of acute illness or metabolically unstable chronic illness (including diagnosis of Insulin Dependent Diabetes Mellitus) Unwilling to stop taking nutritional supplements containing proteins or free amino acids within 5 days of the first study day until study completion Participated in a nutritional supplement study program within the past 4 weeks Any other condition according to the PI or nurse that would interfere with the study or safety of the subject or influence the results Daily use of supplements containing > 1000 mg EPA+DHA 3 months prior to the first test day 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 Presence of fever within the last 3 days Failure to give informed consent (Possible) Pregnancy Unwilling to comply with any other rules set forth in the Informed Consent Form

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Fish Oil<br>8 grams fish oil | Dietary Supplement: Fish Oil<br>* 4 capsules twice daily with food for 6 weeks<br>|
| Placebo Comparator: Olive Oil<br>8 grams olive oil | Dietary Supplement: Olive Oil<br>* 4 capsules twice daily with food for 6 weeks<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
n-3, Polyunsaturated, Fatty acids, Antigens, Cognition, CD4