ObesityNCT01129050
Effects of Omega-3 Fatty Acids on Markers of Inflammation
A study testing Fish Oil and Flaxseed Oil in people with Obesity and Hypertriglyceridemia, run by Stanford University at 1 site in United States.
Trial summary
The major purpose of this study is to examine the effect of two sources of dietary omega-3 fatty acids, each given at two doses, on potential health benefits related to cardiovascular disease prevention. The two sources of dietary omega-3 fatty acids will be fish oil, and flaxseed oil. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Hypertriglyceridemia, Insulin Resistance
- What is being tested?
- Fish Oil and Flaxseed Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Dec 2008
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both women and men
- Age: > or = 18 years
- Ethnicity and race: All ethnic and racial backgrounds welcome
- As defined in ATP III of the National Cholesterol Education program, the metabolic syndrome will be diagnosed as presence of at least three of the following, which will be measured at the screening clinic visit:
- Central obesity as measured by waist circumference:
- Men: Greater than 40 inches
Show all 38Show fewer
- Women: Greater than 35 inches
- Fasting blood triglycerides greater than or equal to 150 mg/dL
- Blood HDL cholesterol:
- Men: Less than 40 mg/dL
- Women: Less than 50 mg/dL
- Blood pressure greater than or equal to 130/85 mmHg
- Fasting glucose greater than or equal to 100 mg/dL
- Planning to be available for clinic visits and bottle pick-ups for the 8 weeks of study participation
- Ability and willingness to give written informed consent
- No known active psychiatric illness.
- Exclusion Criteria:Daily intake of dietary supplements containing omega-3 FAs within the past month.
- Fasting blood glucose > 140 mg/dL
- Significant liver enzyme abnormality
- AST or ALT more than 2 times the upper limit of normal and/or
- Bilirubin more than 50% the upper limit of normal
- Renal disease as measured at baseline:
- Serum creatinine > 1.30 mg/dL, or
- Calculated creatinine clearance < 71 mL/min
- Self reported personal history of:
- Clotting disorders
- Clinically significant atherosclerosis (e.g., CAD, PAD)
- Malignant neoplasm
- Ongoing infection
- Inflammatory disease (e.g., rheumatoid arthritis)
- Subjects currently receiving the following medications (self report):
- Anti-Inflammatory drugs
- Lipid lowering drugs including statins
- Anti-hypertensive drugs
- Anti-coagulant drugs
- Body Mass Index (BMI) greater than or equal to 40.
- Pregnant or Lactating
- Inability to communicate effectively with study personnel
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Effects of Plant and Marine Omega-3 (w-3) Fatty Acids on Inflammatory Markers In Insulin Resistant Adults
The major purpose of this study is to examine the effect of two sources of dietary omega-3 fatty acids, each given at two doses, on potential health benefits related to cardiovascular disease prevention. The two sources of dietary omega-3 fatty acids will be fish oil, and flaxseed oil.
Read the detailed description
The primary aim of this study is to examine the effect of two sources of dietary omega-3 fatty acids, each given at two doses, on potential health benefits related to cardiovascular disease prevention. The two sources of dietary omega-3 fatty acids will be fish oil, and flaxseed oil. Each will be given at a lower dose that could realistically be achieved from food sources alone, and at a higher dose that could not realistically be achieved from food alone and would require supplementation. The outcomes being studied are markers of inflammation. The subjects being studied are those with elevated risk factors for diabetes and heart disease that meet the criteria for the "metabolic syndrome". These are the people who are currently not diabetic, and who have not been diagnosed yet with heart disease, who are at risk of developing these diseases and who would likely benefit the most from the omega-3 therapy should it prove to be effective.
- Conditions
- Obesity, Hypertriglyceridemia, Insulin Resistance, Hypertension
- Being tested
- Fish Oil, Flaxseed Oil, Placebo
- Keywords
- Fish oil, Omega-3 fatty acids, Metabolic syndrome, Adults
- Medical subject headings
- Obesity, Hypertriglyceridemia, Insulin Resistance, Hypertension, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish OilDietary supplement
Fish oil capsule
Flaxseed OilDietary supplement
Flaxseed oil capsule
PlaceboDietary supplement
Soybean oil capsule
| Study group | Role | What they receive |
|---|---|---|
| Low-dose Flaxseed Oil | Experimental | 2.2 g ALA (alpha-linolenic acid) per day Receives: Dietary Supplement: Flaxseed Oil |
| High-dose Flaxseed Oil | Experimental | 6.6 g ALA (alpha-linolenic acid) per day Receives: Dietary Supplement: Flaxseed Oil |
| Low-dose Fish Oil | Experimental | 1.2 g EPA+DHA (700 mg EPA and 500 mg DHA) per day Receives: Dietary Supplement: Fish Oil |
| High-dose Fish Oil | Experimental | 3.6 g EPA+DHA (2.1 g EPA and 1.5 g DHA) per day Receives: Dietary Supplement: Fish Oil |
| Placebo | Placebo comparator | 4 g or 6 g soybean oil per day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in inflammatory markers (MCP-1, IL-6, and sICAM-1) at 8 weeks.
Change was calculated as the value at 8 weeks minus the value at baseline
Measured: Baseline and 8 weeks
Secondary outcomes (4)
Change from baseline in red blood cells (RBC) Fatty Acids at 8 weeks.
Change was calculated as the value at 8 weeks minus the value at baseline
Measured: Baseline and 8 weeks
Change from baseline in low-density lipoprotein (LDL) cholesterol at 8 weeks.
Change was calculated as the value at 8 weeks minus the value at baseline
Measured: Baseline and 8 weeks
Change from baseline in high-density lipoprotein (HDL) cholesterol at 8 weeks.
Change was calculated as the value at 8 weeks minus the value at baseline
Measured: Baseline and 8 weeks
Change from baseline in triglycerides at 8 weeks.
Change was calculated as the value at 8 weeks minus the value at baseline
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startApr 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Christopher Gardner, Stanford University
- Investigators
- Christopher D Gardner, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129050
- Sponsor's protocol ID
- SU-05042010-5842
- Other IDs
- R21AT003465-01
- Status last verified
- Feb 2023
- First submitted
- 20 May 2010
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dewell A, Marvasti FF, Harris WS, Tsao P, Gardner CD. Low- and high-dose plant and marine (n-3) fatty acids do not affect plasma inflammatory markers in adults with metabolic syndrome. J Nutr. 2011 Dec;141(12):2166-71. doi: 10.3945/jn.111.142240. Epub 2011 Oct 26.
PubMed 22031659
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Plant and Marine Omega-3 (w-3) Fatty Acids on Inflammatory Markers In Insulin Resistant Adults
- ClinicalTrials.gov ID
- NCT01129050
- Acronym / sponsor ID
- SU-05042010-5842
- Conditions
- Obesity, Hypertriglyceridemia, Insulin Resistance, Hypertension
- Keywords
- Fish oil, Omega-3 fatty acids, Metabolic syndrome, Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Apr 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 24 May 2010 (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 major purpose of this study is to examine the effect of two sources of dietary omega-3 fatty acids, each given at two doses, on potential health benefits related to cardiovascular disease prevention. The two sources of dietary omega-3 fatty acids will be fish oil, and flaxseed oil.
Detailed description
The primary aim of this study is to examine the effect of two sources of dietary omega-3 fatty acids, each given at two doses, on potential health benefits related to cardiovascular disease prevention. The two sources of dietary omega-3 fatty acids will be fish oil, and flaxseed oil. Each will be given at a lower dose that could realistically be achieved from food sources alone, and at a higher dose that could not realistically be achieved from food alone and would require supplementation. The outcomes being studied are markers of inflammation. The subjects being studied are those with elevated risk factors for diabetes and heart disease that meet the criteria for the "metabolic syndrome". These are the people who are currently not diabetic, and who have not been diagnosed yet with heart disease, who are at risk of developing these diseases and who would likely benefit the most from the omega-3 therapy should it prove to be effective.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Low-dose Flaxseed Oil | Experimental | Dietary Supplement: Flaxseed Oil2.2 g ALA (alpha-linolenic acid) per day |
| High-dose Flaxseed Oil | Experimental | Dietary Supplement: Flaxseed Oil6.6 g ALA (alpha-linolenic acid) per day |
| Low-dose Fish Oil | Experimental | Dietary Supplement: Fish Oil1.2 g EPA+DHA (700 mg EPA and 500 mg DHA) per day |
| High-dose Fish Oil | Experimental | Dietary Supplement: Fish Oil3.6 g EPA+DHA (2.1 g EPA and 1.5 g DHA) per day |
| Placebo | Placebo comparator | Dietary Supplement: Placebo4 g or 6 g soybean oil per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (38 listed)
- Both women and men
- Age: > or = 18 years
- Ethnicity and race: All ethnic and racial backgrounds welcome
- As defined in ATP III of the National Cholesterol Education program, the metabolic syndrome will be diagnosed as presence of at least three of the following, which will be measured at the screening clinic visit:
- Men: Greater than 40 inches
Key exclusion criteria (0 listed)
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 OilFish oil capsule | Dietary supplement | High-dose Fish Oil, Low-dose Fish Oil |
| Flaxseed OilFlaxseed oil capsule | Dietary supplement | High-dose Flaxseed Oil, Low-dose Flaxseed Oil |
| PlaceboSoybean oil capsule | Dietary supplement | Placebo |
Primary outcome
Change from baseline in inflammatory markers (MCP-1, IL-6, and sICAM-1) at 8 weeks.
Time frame: Baseline and 8 weeks
Change was calculated as the value at 8 weeks minus the value at baseline
4 secondary outcomes
Change from baseline in red blood cells (RBC) Fatty Acids at 8 weeks.
Time frame: Baseline and 8 weeks
Change from baseline in low-density lipoprotein (LDL) cholesterol at 8 weeks.
Time frame: Baseline and 8 weeks
Change from baseline in high-density lipoprotein (HDL) cholesterol at 8 weeks.
Time frame: Baseline and 8 weeks
Change from baseline in triglycerides at 8 weeks.
Time frame: Baseline and 8 weeks
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 Feb 2023.
- Results publication: PubMed 22031659Dewell A, Marvasti FF, Harris WS, Tsao P, Gardner CD. Low- and high-dose plant and marine (n-3) fatty acids do not affect plasma inflammatory markers in adults with metabolic syndrome. J Nutr. 2011 Dec;141(12):2166-71. doi: 10.3945/jn.111.142240. Epub 2011 Oct 26.
- Study description and summary of resultsLink 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.
Christopher D Gardner principal investigator
Stanford 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 Flaxseed Oil in people with Obesity and Hypertriglyceridemia, run by Stanford 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 38 inclusion and 0 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 Feb 2023. 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 from baseline in inflammatory markers (MCP-1, IL-6, and sICAM-1) at 8 weeks. (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01129050, which also lists 1 linked publication.
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 Feb 2023.