Body WeightNCT00935922
CCRC: Understanding the Effects of Omega-3 Fatty Acids Versus Lignans in Flaxseed on Metabolic and Inflammatory Markers Leading to Diabetes and Cardiovascular Disease
A study testing Flaxseed in people with Body Weight and Lipids, run by University of California, Davis at 1 site in United States.
Trial summary
The aim of this study is to compare the effects of flaxseed on atherogenic lipids, plasma inflammatory markers, and insulin sensitivity. We hypothesize that flaxseed omega-3 fatty acids will improve the lipid profile (decrease triglyceride, total and LDL-cholesterol and increase HDL-cholesterol). Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight, Lipids, Blood Glucose
- What is being tested?
- Flaxseed
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Apr 2010
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or postmenopausal women in the 40-65 years age range. Body Mass Index in the range of 25-39
Who cannot join
- Women are are premenopausal
- Smoking
- Diabetes
- Cancer
- Gout
- Untreated thyroid disease
Show all 13Show fewer
- Kidney Disease
- Liver Disease
- Use of lipid lowering drugs
- Use of insulin sensitizing drugs
- Use of ACE inhibitors or other blood pressure lowering medications
- Use of over the counter or prescription anti-obesity medications
- Weight loss of 10% or more within the last 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CCRC: Understanding the Effects of Omega-3 Fatty Acids vs. Lignans in Flaxseed on Metabolic and Inflammatory Markers Leading to Diabetes and Cardiovascular Disease.
The aim of this study is to compare the effects of flaxseed on atherogenic lipids, plasma inflammatory markers, and insulin sensitivity.
We hypothesize that flaxseed omega-3 fatty acids will improve the lipid profile (decrease triglyceride, total and LDL-cholesterol and increase HDL-cholesterol).
Flaxseed is the richest dietary source of lignan secoisolariciresinol diglucoside (SDG). Lignans are estrogens found in plant sources that behave similar to endogenous estrogens and have been associated with cardiovascular benefits due to their antioxidant activity. Therefore, we also hypothesize that flax-lignans will cause a significant decrease in LDL oxidation and in inflammatory markers such as C-reactive protein (CRP), interleukin-6 (IL-6), IL-1B, serum fatty acid binding protein 4 (FABP-4), and serum amyloid attached to high density lipoprotein (HDL-SAA).
- Conditions
- Body Weight, Lipids, Blood Glucose, Insulin
- Being tested
- Flaxseed
- Keywords
- Flaxseed, Weight loss, Heart health, Diabetes
- Medical subject headings
- Body Weight, Insulin Resistance, Weight Loss, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlaxseedDietary supplement
Flaxseed omega-3 fatty acids and lignans
| Study group | Role | What they receive |
|---|---|---|
| Soybean oil bar | Placebo comparator | A nutrition bar enriched with soybean oil Receives: Dietary Supplement: Flaxseed |
| Flaxseed bar with low lignans | Experimental | A nutrition bar enriched with flaxseed oil Receives: Dietary Supplement: Flaxseed |
| Flaxseed bars with high lignans | Experimental | A nutrition bar enriched with flaxseed oil and high lignans Receives: Dietary Supplement: Flaxseed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved lipid profile
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startFeb 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body WeightStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Flax Canada 2015 Inc.
- Responsible party
- Principal investigator, Sidika E. Karakas, MD, University of California, Davis
- Investigators
- Sidika Kasim-Karakas, MD, Principal investigator, University of California, Davis Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935922
- Sponsor's protocol ID
- 200816799-1
- Status last verified
- Jul 2009
- First submitted
- 7 Jul 2009
- Last updated
- 29 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CCRC: Understanding the Effects of Omega-3 Fatty Acids vs. Lignans in Flaxseed on Metabolic and Inflammatory Markers Leading to Diabetes and Cardiovascular Disease.
- ClinicalTrials.gov ID
- NCT00935922
- Acronym / sponsor ID
- 200816799-1
- Conditions
- Body Weight, Lipids, Blood Glucose, Insulin
- Keywords
- Flaxseed, Weight loss, Heart health, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Flax Canada 2015 Inc.
- Study start
- Feb 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 9 Jul 2009 (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 aim of this study is to compare the effects of flaxseed on atherogenic lipids, plasma inflammatory markers, and insulin sensitivity.
We hypothesize that flaxseed omega-3 fatty acids will improve the lipid profile (decrease triglyceride, total and LDL-cholesterol and increase HDL-cholesterol).
Flaxseed is the richest dietary source of lignan secoisolariciresinol diglucoside (SDG). Lignans are estrogens found in plant sources that behave similar to endogenous estrogens and have been associated with cardiovascular benefits due to their antioxidant activity. Therefore, we also hypothesize that flax-lignans will cause a significant decrease in LDL oxidation and in inflammatory markers such as C-reactive protein (CRP), interleukin-6 (IL-6), IL-1B, serum fatty acid binding protein 4 (FABP-4), and serum amyloid attached to high density lipoprotein (HDL-SAA).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Soybean oil bar | Placebo comparator | Dietary Supplement: FlaxseedA nutrition bar enriched with soybean oil |
| Flaxseed bar with low lignans | Experimental | Dietary Supplement: FlaxseedA nutrition bar enriched with flaxseed oil |
| Flaxseed bars with high lignans | Experimental | Dietary Supplement: FlaxseedA nutrition bar enriched with flaxseed oil and high lignans |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men or postmenopausal women in the 40-65 years age range. Body Mass Index in the range of 25-39
Key exclusion criteria (13 listed)
- Women are are premenopausal
- Smoking
- Diabetes
- Cancer
- Gout
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 |
|---|---|---|
| FlaxseedFlaxseed omega-3 fatty acids and lignans | Dietary supplement | Flaxseed bar with low lignans, Flaxseed bars with high lignans, Soybean oil bar |
Primary outcome
Improved lipid profile
Time frame: six 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 29 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.
Sidika Kasim-Karakas, MD principal investigator
University of California, Davis Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flaxseed in people with Body Weight and Lipids, run by University of California, Davis 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 13 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 29 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 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?
Improved lipid profile (time frame: six weeks). 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 29 Oct 2012.