Muscle StrengthNCT02775084
Fish Oil T Cell Function
A study testing Fish Oil and Olive Oil in people with Muscle Strength and Cognitive Function, run by Texas A&M University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Strength, Cognitive Function
- What is being tested?
- Fish Oil and Olive Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female according to the investigator/appointed staff judgment
- 55 years and older
- Stable body weight for the past 3 months (< 5% change)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas A&M University-CTRAL
College Station, Texas, 77843
About this study
Official title: 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).
Read the 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.
- Conditions
- Muscle Strength, Cognitive Function
- Being tested
- Fish Oil, Olive Oil
- Keywords
- n-3, Polyunsaturated, Fatty acids, Antigens, Cognition, CD4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish OilDietary supplement
4 capsules twice daily with food for 6 weeks
Olive OilDietary supplement
4 capsules twice daily with food for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Healthy Fish Oil | Experimental | 8 grams fish oil Receives: Dietary Supplement: Fish Oil |
| Olive Oil | Placebo comparator | 8 grams olive oil Receives: Dietary Supplement: Olive Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one time on baseline, day 21 and day 42
Secondary outcomes (12)
Fatty acid metabolism
One blood draw on each study visit
Measured: one time on baseline, day 21 and day 42
Skeletal muscle strength of hand
Measurement of hand grip strength
Measured: 30 minutes on baseline, day 21 and day 42
Skeletal muscle strength of leg
Measurement of muscle strength of leg using kin-com machine
Measured: 30 minutes on baseline, day 21 and day 42
Body Composition
Body composition as measured by Dual-Energy X-ray Absorptiometry
Measured: 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
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.
Measured: Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
Recall of numbers in the same order (Digit Forward) and in reverse order (Digit Backward). Measures auditory attention and verbal working memory.
Measured: 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)
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.
Measured: 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)
A standardized self-questionnaire that generates an individualized profile of sensory processing across four quadrants: low registration, sensation seeking, sensory sensitivity, and sensation avoiding.
Measured: 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
A standardized self-report that captures views of an adult's executive functions or self-regulation in his or her everyday environment.
Measured: Postabsorptive state during 1 hours and change after feeding on baseline and change from day 21 and day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle StrengthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marielle PKJ Engelen, PhD, Texas A&M University
- Investigators
- Marielle Engelen, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775084
- Sponsor's protocol ID
- IRB2015-0691
- Status last verified
- Apr 2019
- First submitted
- 10 May 2016
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Intervention to Test Effect on Healthy Human T Cell Function
- ClinicalTrials.gov ID
- NCT02775084
- Acronym / sponsor ID
- IRB2015-0691
- Conditions
- Muscle Strength, Cognitive Function
- Keywords
- n-3, Polyunsaturated, Fatty acids, Antigens, Cognition, CD4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 17 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Fish Oil | Experimental | Dietary Supplement: Fish Oil8 grams fish oil |
| Olive Oil | Placebo comparator | Dietary Supplement: Olive Oil8 grams olive oil |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male or female according to the investigator/appointed staff judgment
- 55 years and older
- Stable body weight for the past 3 months (< 5% change)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish Oil4 capsules twice daily with food for 6 weeks | Dietary supplement | Healthy Fish Oil |
| Olive Oil4 capsules twice daily with food for 6 weeks | Dietary supplement | Olive Oil |
Primary outcome
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
12 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marielle Engelen principal investigator
Texas A&M University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish Oil and Olive Oil in people with Muscle Strength and Cognitive Function, run by Texas A&M University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2019.