NCT02775084

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 17, 2016

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

5 months

First QC Date

May 10, 2016

Last Update Submit

April 19, 2019

Conditions

Muscle StrengthCognitive Function

Keywords

n-3PolyunsaturatedFatty acidsAntigensCognitionCD4

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Fatty acid metabolism

    one time on baseline, day 21 and day 42

  • Skeletal muscle strength of hand

    30 minutes on baseline, day 21 and day 42

  • Skeletal muscle strength of leg

    30 minutes on baseline, day 21 and day 42

  • Body Composition

    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

    Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42

  • +7 more secondary outcomes

Study Arms (2)

Healthy Fish Oil

EXPERIMENTAL

8 grams fish oil

Dietary Supplement: Fish Oil

Olive Oil

PLACEBO COMPARATOR

8 grams olive oil

Dietary Supplement: Olive Oil

Interventions

Fish OilDIETARY_SUPPLEMENT

4 capsules twice daily with food for 6 weeks

Healthy Fish Oil
Olive OilDIETARY_SUPPLEMENT

4 capsules twice daily with food for 6 weeks

Olive Oil

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male or female according to the investigator/appointed staff judgment
  • years and older
  • Stable body weight for the past 3 months (\< 5% change)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas A&M University-CTRAL

College Station, Texas, 77843, United States

Location

MeSH Terms

Interventions

Fish OilsOlive Oil

Intervention Hierarchy (Ancestors)

OilsLipidsDietary Fats, UnsaturatedDietary FatsFatsFats, UnsaturatedPlant OilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Marielle Engelen

    Texas A&M University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 10, 2016

First Posted

May 17, 2016

Study Start

January 1, 2016

Primary Completion

June 1, 2016

Study Completion

April 1, 2019

Last Updated

April 22, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)