Overview

This trial is active, not recruiting.

Conditions muscle strength, cognitive function
Treatments fish oil, olive oil
Sponsor Texas A&M University
Start date January 2016
End date June 2016
Trial size 13 participants
Trial identifier NCT02775084, IRB2015-0691

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Arm
(Experimental)
8 grams fish oil
fish oil
4 capsules twice daily with food for 6 weeks
(Placebo Comparator)
8 grams olive oil
olive oil
4 capsules twice daily with food for 6 weeks

Primary Outcomes

Measure
Change in function of of lipid rafts in immune cell membranes due to dietary polyunsaturated fatty acids supplementation
time frame: one time on baseline, day 21 and day 42

Secondary Outcomes

Measure
Fatty acid metabolism
time frame: one time on baseline, day 21 and day 42
Skeletal muscle strength of hand
time frame: 30 minutes on baseline, day 21 and day 42
Skeletal muscle strength of leg
time frame: 30 minutes on baseline, day 21 and day 42
Body Composition
time frame: 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
time frame: Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42
Diet recall
time frame: 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)
time frame: 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)
time frame: 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
time frame: 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)
time frame: 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)
time frame: 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
time frame: Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42

Eligibility Criteria

Male or female participants at least 55 years old.

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

Additional Information

Official title Nutritional Intervention to Test Effect on Healthy Human T Cell Function
Principal investigator Marielle Engelen
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Texas A&M University.