Fish Oil T Cell Function

Cognitive Function Clinical Trial

Official title:

Nutritional Intervention to Test Effect on Healthy Human T Cell Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02775084
• Other study ID #: IRB2015-0691
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: April 2019

Study information

• Verified date: April 2019
• Source: Texas A&M University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 2019
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Function
• Muscle Strength

Intervention

Dietary Supplement:
• Fish Oil
4 capsules twice daily with food for 6 weeks
• Olive Oil
4 capsules twice daily with food for 6 weeks

Locations

Country	Name	City	State
United States	Texas A&M University-CTRAL	College Station	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas A&M University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fatty acid metabolism	One blood draw on each study visit	one time on baseline, day 21 and day 42
Secondary	Skeletal muscle strength of hand	Measurement of hand grip strength	30 minutes on baseline, day 21 and day 42
Secondary	Skeletal muscle strength of leg	Measurement of muscle strength of leg using kin-com machine	30 minutes on baseline, day 21 and day 42
Secondary	Body Composition	Body composition as measured by Dual-Energy X-ray Absorptiometry	15 minutes on baseline, day 21 and day 42
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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