Fish Oil T Cell Function

April 19, 2019 updated by: Marielle PKJ Engelen, PhD, Texas A&M University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
one blood draw on each study visit
one time on baseline, day 21 and day 42

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fatty acid metabolism
Time Frame: one time on baseline, day 21 and day 42
One blood draw on each study visit
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
Measurement of hand grip strength
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
Measurement of muscle strength of leg using kin-com machine
30 minutes on baseline, day 21 and day 42
Body Composition
Time Frame: 15 minutes on baseline, day 21 and day 42
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
Time Frame: Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42
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
Time Frame: on baseline and change from day 21 and day 42
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)
Time Frame: Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42
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)
Time Frame: Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42
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
Time Frame: Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42
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)
Time Frame: Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42
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)
Time Frame: Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42
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
Time Frame: Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas A&M University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marielle Engelen, Texas A&M University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB2015-0691

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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