InflammationNCT01666392
Omega-3 Fatty Acid Supplementation in Older Adults
A study testing Omega-3 fatty acid in people with Inflammation, run by University of Memphis at 1 site in United States.
Trial summary
The purpose of this study to determine whether Fish oil (Omega-3 Fatty Acid) supplementation has an impact on inflammation and lean body mass in older adults. The investigators expect that Fish oil supplementation will reduce inflammation and prevent the loss of lean mass compared to placebo. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Omega-3 fatty acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Apr 2013
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 years of age or over
Who cannot join
- Fish, seafood allergies, nut allergies, soy allergies
- Habitual (>1/week) fish or seafood consumption
- Current Omega-3 supplement use
- Gastrointestinal problems
- Current anti-inflammatory medication use
- Current anticoagulant medication use
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Health and Sport Sciences, The University of Memphis
Memphis, Tennessee, 38152
About this study
Official title: The Impact of Omega-3 Fatty Acid Supplementation on Markers of Inflammation and Lean Body Mass in Older Adults
The purpose of this study to determine whether Fish oil (Omega-3 Fatty Acid) supplementation has an impact on inflammation and lean body mass in older adults. The investigators expect that Fish oil supplementation will reduce inflammation and prevent the loss of lean mass compared to placebo.
- Conditions
- Inflammation
- Being tested
- Omega-3 fatty acid, Placebo
- Keywords
- Omega-3 fatty acid, Fish oil, Muscle mass, Muscle strength, Older adults, Circulating inflammatory cytokines, Skeletal muscle mass, Upper body strength, Lower body strength
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acidDietary supplement
Also called ProOmega (Nordic Naturals)
Omega-3 fatty acid, Eicosapentaenoic acid+docosahexaenoic acid in capsule form
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Fish oil (Omega-3 fatty acid) | Experimental | 2 capsules/day of ProOmega providing 650mg EPA and 450mg DHA Receives: Dietary Supplement: Omega-3 fatty acid |
| Soybean oil | Placebo comparator | 2 capsules/day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-Reactive protein
Inflammatory marker
Measured: At baseline testing and at 3 month endpoint
IL6
Inflammatory cytokine
Measured: At baseline and at 3 month endpoint
TNFα
Inflammatory cytokine
Measured: At baseline and at 3 month endpoint
Secondary outcomes (3)
Skeletal muscle mass/body composition
The amount of skeletal muscle mass and fat mass and their ration will be determined.
Measured: At baseline testing and at 3 month endpoint
Lower body muscular strength
Measurement of maximum strength in the leg press exercise
Measured: At baseline and at 3 month endpoint
Upper body muscular strength
Measurement of maximum strength in the chest press exercise
Measured: At baseline and at 3 month endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Memphis
- Sponsor type
- University, hospital or other
- Collaborators
- Nordic Naturals
- Responsible party
- Principal investigator, Zsolt Murlasits, University of Memphis
- Investigators
- Zsolt Murlasits, Ph.D., Principal investigator, The University of Memphis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666392
- Sponsor's protocol ID
- #2232
- Other IDs
- #2232
- Status last verified
- Aug 2012
- First submitted
- 10 Aug 2012
- Last updated
- 10 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Omega-3 Fatty Acid Supplementation on Markers of Inflammation and Lean Body Mass in Older Adults
- ClinicalTrials.gov ID
- NCT01666392
- Acronym / sponsor ID
- #2232
- Conditions
- Inflammation
- Keywords
- Omega-3 fatty acid, Fish oil, Muscle mass, Muscle strength, Older adults, Circulating inflammatory cytokines, Skeletal muscle mass, Upper body strength
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MemphisUniversity, hospital or other
- Collaborators
- Nordic Naturals
- Study start
- Aug 2012
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 16 Aug 2012 (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 this study to determine whether Fish oil (Omega-3 Fatty Acid) supplementation has an impact on inflammation and lean body mass in older adults. The investigators expect that Fish oil supplementation will reduce inflammation and prevent the loss of lean mass compared to placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish oil (Omega-3 fatty acid) | Experimental | Dietary Supplement: Omega-3 fatty acid2 capsules/day of ProOmega providing 650mg EPA and 450mg DHA |
| Soybean oil | Placebo comparator | Dietary Supplement: Placebo2 capsules/day |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 60 years of age or over
Key exclusion criteria (6 listed)
- Fish, seafood allergies, nut allergies, soy allergies
- Habitual (>1/week) fish or seafood consumption
- Current Omega-3 supplement use
- Gastrointestinal problems
- Current anti-inflammatory medication use
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 |
|---|---|---|
| Omega-3 fatty acidAlso: ProOmega (Nordic Naturals)Omega-3 fatty acid, Eicosapentaenoic acid+docosahexaenoic acid in capsule form | Dietary supplement | Fish oil (Omega-3 fatty acid) |
| PlaceboPlacebo | Dietary supplement | Soybean oil |
Primary outcome
C-Reactive protein
Time frame: At baseline testing and at 3 month endpoint
Inflammatory marker
IL6
Time frame: At baseline and at 3 month endpoint
Inflammatory cytokine
TNFα
Time frame: At baseline and at 3 month endpoint
Inflammatory cytokine
3 secondary outcomes
Skeletal muscle mass/body composition
Time frame: At baseline testing and at 3 month endpoint
Lower body muscular strength
Time frame: At baseline and at 3 month endpoint
Upper body muscular strength
Time frame: At baseline and at 3 month endpoint
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2012.
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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.
Zsolt Murlasits, Ph.D. principal investigator
The University of Memphis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 fatty acid in people with Inflammation, run by University of Memphis 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 1 inclusion and 6 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: withdrawn, as of the sponsor's last update on 10 Oct 2012. 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 was withdrawn before enrolling participants, so there are no results.
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?
C-Reactive protein (time frame: At baseline testing and at 3 month endpoint). The study lists 3 primary outcomes in all. 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 10 Oct 2012.