ObesityNCT02204709
Disease Risk Reduction and Omega-3 Rich Rainbow Trout (Fish for Health)
A study testing 2N Trout, 3N Trout and Tilapia in people with Obesity, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial summary
The purpose of this study is to determine how eating fish raised to have different levels of omega-3 fatty acids will reduce cardiovascular risk markers in people with elevated cardiovascular risk. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- 2N Trout, 3N Trout and Tilapia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 25 Mar 2020
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI of 30 - 39.9 kg/m2
Who cannot join
- Are allergic to fish
- Use tobacco products or nicotine in any form including snuff, pills, and patches, or e-cigarettes in the past 6 months
- Have established cardiovascular, pulmonary, and/or a metabolic disease such as diabetes
- Have uncontrolled high blood pressure
- Have alcohol, anabolic steroids, or other substance abuse issues
- Consume more than 3 alcoholic drinks/week
Show all 9Show fewer
- Have cancer
- Are pregnant or nursing
- Take non-steroidal anti-inflammatory drugs such as aspirin, ibuprofen or Aleve, lipid modifying drugs such as statins, take medications for blood glucose such as insulin or metformin
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58203
About this study
Official title: Disease Risk Reduction and n-3 Rich Rainbow Trout (Fish for Health)
The purpose of this study is to determine how eating fish raised to have different levels of omega-3 fatty acids will reduce cardiovascular risk markers in people with elevated cardiovascular risk.
Read the detailed description
Consumption of fish high in long chain omega-3 fatty acids (LCn3) is associated with reduction of cardiovascular disease (CVD) risk. CVD is a major cause of death in the United States. The current obesity epidemic contributes significantly to elevated CVD risk by increasing inflammation and platelet dysfunction. Prevention of CVD is a public health goal and comprises several avenues of action, of which inclusion of LCn3-rich fish in the diet may be one of the most effective.
Obese participants will participate in a double blind, randomized, cross-over designed trial in which they will consume twice-weekly a prepared meal containing diploid (2N) farmed rainbow trout, triploid (3N) farmed rainbow trout containing higher levels of LCn3, or tilapia, a low LCn3 fish.
- Conditions
- Obesity
- Being tested
- 2N Trout, 3N Trout, Tilapia
- Keywords
- obese, omega-3 fatty acids, fish
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2N TroutOther
Diploid/2N trout source
3N TroutOther
Triploid/3N trout source
TilapiaOther
Tilapia/control fish source
| Study group | Role | What they receive |
|---|---|---|
| Diploid Trout entrees | Experimental | Subjects will consume a 200 gram portion of 2N trout (diploid; two sets of chromosomes) twice weekly in a prepared meal. Receives: Other: 2N Trout |
| Triploid Trout entrees | Experimental | Subjects will consume a 200 gram portion of 3N trout (triploid; three sets of chromosomes) twice weekly in a prepared meal. Receives: Other: 3N Trout |
| Tilapia entrees | Experimental | Subjects will consume a 200 gram portion of tilapia twice weekly in a prepared meal. Receives: Other: Tilapia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in platelet activation at week 6 of each treatment
Measured: Baseline, Week 6
Secondary outcomes (8)
Change from baseline in plasma interleukin-6 (IL-6) at week 6 of each treatment
Measured: Baseline, Week 6
Change from baseline in plasma tumor necrosis factor alpha (TNFa) at week 6 of each treatment
Measured: Baseline, Week 6
Change from baseline in urinary prostaglandin E2 (PGE2) at week 6 of each treatment
Measured: Baseline, Week 6
Change from baseline in urinary thromboxane B2 (TxB2-M) at week 6 of each treatment
Measured: Baseline, Week 6
Change from baseline in urinary prostaglandin I2 (PGI2-M) at week 6 of each treatment
Measured: Baseline, Week 6
Change from baseline in serum thromboxane B2 (TxB2) at week 6 of each treatment
Measured: Baseline, Week 6
Change from baseline in plasma phospholipid fatty acids at week 6 of each treatment
Measured: Baseline, Week 6
Change from baseline in platelet fatty acids at week 6 of each treatment
Measured: Baseline, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startJun 2015
- Primary completion25 Mar 2020
- Study completion25 Mar 2020
Why it stopped: COVID-19 pandemic \& expiration of grant funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Matthew Picklo, PhD, Principal investigator, USDA Grand Forks Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204709
- Sponsor's protocol ID
- GFHNRC029
- Status last verified
- Aug 2022
- First submitted
- 28 Jul 2014
- Last updated
- 4 Aug 2022
- 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 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease Risk Reduction and n-3 Rich Rainbow Trout (Fish for Health)
- ClinicalTrials.gov ID
- NCT02204709
- Acronym / sponsor ID
- GFHNRC029
- Conditions
- Obesity
- Keywords
- obese, omega-3 fatty acids, fish
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic \& expiration of grant funds
- Enrolment
- 29 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Study start
- Jun 2015 (actual)
- Primary completion
- 25 Mar 2020 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 30 Jul 2014 (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 is to determine how eating fish raised to have different levels of omega-3 fatty acids will reduce cardiovascular risk markers in people with elevated cardiovascular risk.
Detailed description
Consumption of fish high in long chain omega-3 fatty acids (LCn3) is associated with reduction of cardiovascular disease (CVD) risk. CVD is a major cause of death in the United States. The current obesity epidemic contributes significantly to elevated CVD risk by increasing inflammation and platelet dysfunction. Prevention of CVD is a public health goal and comprises several avenues of action, of which inclusion of LCn3-rich fish in the diet may be one of the most effective.
Obese participants will participate in a double blind, randomized, cross-over designed trial in which they will consume twice-weekly a prepared meal containing diploid (2N) farmed rainbow trout, triploid (3N) farmed rainbow trout containing higher levels of LCn3, or tilapia, a low LCn3 fish.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diploid Trout entrees | Experimental | Other: 2N TroutSubjects will consume a 200 gram portion of 2N trout (diploid; two sets of chromosomes) twice weekly in a prepared meal. |
| Triploid Trout entrees | Experimental | Other: 3N TroutSubjects will consume a 200 gram portion of 3N trout (triploid; three sets of chromosomes) twice weekly in a prepared meal. |
| Tilapia entrees | Experimental | Other: TilapiaSubjects will consume a 200 gram portion of tilapia twice weekly in a prepared meal. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI of 30 - 39.9 kg/m2
Key exclusion criteria (9 listed)
- Are allergic to fish
- Use tobacco products or nicotine in any form including snuff, pills, and patches, or e-cigarettes in the past 6 months
- Have established cardiovascular, pulmonary, and/or a metabolic disease such as diabetes
- Have uncontrolled high blood pressure
- Have alcohol, anabolic steroids, or other substance abuse issues
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 |
|---|---|---|
| 2N TroutDiploid/2N trout source | Other | Diploid Trout entrees |
| 3N TroutTriploid/3N trout source | Other | Triploid Trout entrees |
| TilapiaTilapia/control fish source | Other | Tilapia entrees |
Primary outcome
Change from baseline in platelet activation at week 6 of each treatment
Time frame: Baseline, Week 6
8 secondary outcomes
Change from baseline in plasma interleukin-6 (IL-6) at week 6 of each treatment
Time frame: Baseline, Week 6
Change from baseline in plasma tumor necrosis factor alpha (TNFa) at week 6 of each treatment
Time frame: Baseline, Week 6
Change from baseline in urinary prostaglandin E2 (PGE2) at week 6 of each treatment
Time frame: Baseline, Week 6
Change from baseline in urinary thromboxane B2 (TxB2-M) at week 6 of each treatment
Time frame: Baseline, Week 6
Change from baseline in urinary prostaglandin I2 (PGI2-M) at week 6 of each treatment
Time frame: Baseline, Week 6
Change from baseline in serum thromboxane B2 (TxB2) at week 6 of each treatment
Time frame: Baseline, Week 6
Change from baseline in plasma phospholipid fatty acids at week 6 of each treatment
Time frame: Baseline, Week 6
Change from baseline in platelet fatty acids at week 6 of each treatment
Time frame: Baseline, Week 6
Results and safety
The study was stopped early (reason given: COVID-19 pandemic \& expiration of grant funds). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Grand Forks Human Nutrition Research Center Current Nutrition StudiesLink provided by the sponsor.
- 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.
Matthew Picklo, PhD principal investigator
USDA Grand Forks Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2N Trout, 3N Trout and Tilapia in people with Obesity, run by USDA Grand Forks Human Nutrition Research Center 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 9 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: stopped early, as of the sponsor's last update on 4 Aug 2022. 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. 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 stopped early (reason given: COVID-19 pandemic \& expiration of grant funds). Results are not available in the source record.
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 from baseline in platelet activation at week 6 of each treatment (time frame: Baseline, Week 6). 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 4 Aug 2022.