Clinical trial NCT02775084: Fish Oil T Cell Function
Official title: Nutritional Intervention to Test Effect on Healthy Human T Cell Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Strength
Cognitive Function
Keywords: n-3
Polyunsaturated
Fatty acids
Antigens
Cognition
CD4
Lead sponsor: Texas A&M University
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 13
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change in function of of lipid rafts in immune cell membranes due to dietary polyunsaturated fatty acids supplementation
timeFrame: one time on baseline, day 21 and day 42
Secondary outcomes:
measure: Fatty acid metabolism
timeFrame: one time on baseline, day 21 and day 42
measure: Skeletal muscle strength of hand
timeFrame: 30 minutes on baseline, day 21 and day 42
measure: Skeletal muscle strength of leg
timeFrame: 30 minutes on baseline, day 21 and day 42
measure: Body Composition
timeFrame: 15 minutes on baseline, day 21 and day 42
measure: Group differences in state of mood as measured by the Hospital Anxiety and Depression Scale (HADS
timeFrame: Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42
measure: Diet recall
timeFrame: on baseline and change from day 21 and day 42
measure: Group differences in attention and executive functions as measured by Stroop Color-Word Test (SCWT)
timeFrame: Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42
measure: Group differences in attention and executive functions as measured by Trail Making Test (TMT)
timeFrame: Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42
measure: Group differences in learning and memory as measured by Digit Span
timeFrame: Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42
measure: Group differences in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)
timeFrame: Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42
measure: Executive Function-Adolescent/Adult Sensory Profile (ASP)
timeFrame: Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42
measure: Group differences in attention and executive functions as measured by Brief-A
timeFrame: Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42
Other outcomes:
Locations:
city: College Station
country: United States
facility: Texas A&M University-CTRAL
state: Texas
Study officials:
affiliation: Texas A&M University
name: Marielle Engelen
role: PRINCIPAL_INVESTIGATOR
References: