HypercholesterolemiaISULignanNCT01314586
Flax Lignans and Heart Health
A study testing secoisolariciresinol diglucoside-containing extract of flaxseed in people with Hypercholesterolemia, run by Iowa State University at 1 site in United States.
Trial summary
Purpose: To demonstrate the efficacy of Beneflax™ flaxseed lignan (SDG) concentrate to lower serum cholesterol levels. Background: Flaxseed has been studied for various health benefits in humans, including prostate health, glucose control, and cardiovascular health. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- secoisolariciresinol diglucoside-containing extract of flaxseed
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Nov 2009
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men, 40-65 yrs/old, postmenopausal women 50-65 yrs/old not > 5 yrs post menopause. All subjects were hypercholesterolemic with either total cholesterol >240 mg/dl and < 320 mg/dL or LDL cholesterol >140 mg/dl and <190 mg/dl at the screening visit.
Who cannot join
- Excluded subjects included diabetics, people being actively treated with niacins, fibrates, statins, insulin, ACE inhibitors or other cholesterol/ blood pressure pharmaceutical treatments, people who consumed large amounts of soy, flax, rye breads, pumpkin seeds, hydrolyzed milk products, sterols, and/or berries (strawberries/blueberries) or supplements aimed at cholesterol reduction such as spruce lignans, sytrinol (poly methoxylated flavanols), polycosinols, people consuming flaxseed on a regular basis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nutrition & Wellness Research Center
Ames, Iowa, 50011
About this study
Official title: Iowa State Study on Flax Lignans and Heart Health
Purpose: To demonstrate the efficacy of Beneflax™ flaxseed lignan (SDG) concentrate to lower serum cholesterol levels.
Background: Flaxseed has been studied for various health benefits in humans, including prostate health, glucose control, and cardiovascular health. Cholesterol levels and high blood pressure are known to be risk factors for cardiovascular disease. Whole flaxseed has had variable effects on serum lipid levels, perhaps a consequence of variations in the amounts of secoisolariciresinol diglucoside (SDG) found in different flax cultivars, making the study of this bioactive compound difficult.
Hypothesis: Flaxseed lignan (SDG) extract (Beneflax) significantly lowers total and LDL cholesterol. Flaxseed lignans also lower blood pressure and fasting glucose levels.
- Conditions
- Hypercholesterolemia
- Being tested
- secoisolariciresinol diglucoside-containing extract of flaxseed
- Keywords
- hypercholesterolemia, postmenopause, secoisolariciresinol diglucoside, flaxseed, lignans, enterolactone, enterodiol, serum cholesterol, LDL cholesterol
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
secoisolariciresinol diglucoside-containing extract of flaxseedDietary supplement
Also called Beneflax
0, 150 or 300 mg/day as 2 pills taken at breakfast and dinner, dietary counseling to comply with NCEP Step I diet
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | placebo pill, diet counseling to comply with NCEP Step I diet Receives: Dietary Supplement: secoisolariciresinol diglucoside-containing extract of flaxseed |
| 150 mg/day Beneflax | Experimental | 2 pills taken at breakfast and dinner containing a total of 150 mg secoisolariciresinol (SDG) per day for 12 weeks Receives: Dietary Supplement: secoisolariciresinol diglucoside-containing extract of flaxseed |
| 300 mg/day Beneflax | Experimental | 2 pills taken at breakfast and dinner containing a total of 300 mg secoisolariciresinol (SDG) per day for 12 weeks Receives: Dietary Supplement: secoisolariciresinol diglucoside-containing extract of flaxseed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum total cholesterol from baseline to 12 weeks after intervention treatments
Measured: 12 weeks
Change in serum glucose from baseline to 12 weeks after intervention treatments
Measured: 12 weeks
Change in blood pressure from baseline to end of treatment
Measured: 12 weeks
Secondary outcomes (1)
Changes in serum clinical chemistry from baseline to end of treatment
serum uric acid, BUN, Na, K, Cl, Ca, P, LDH, AST, ALT, bilirubin, carbon dioxide
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startDec 2007
- Primary completionJul 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iowa State University
- Sponsor type
- University, hospital or other
- Collaborators
- Archer Daniels Midland Co.
- Investigators
- Suzanne Hendrich, PhD, Principal investigator, Iowa State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314586
- Sponsor's protocol ID
- ADM Beneflax ISU-1
- Acronym
- ISULignan
- Status last verified
- Mar 2011
- First submitted
- 9 Mar 2011
- Last updated
- 14 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iowa State Study on Flax Lignans and Heart Health
- ClinicalTrials.gov ID
- NCT01314586
- Acronym / sponsor ID
- ISULignan / ADM Beneflax ISU-1
- Conditions
- Hypercholesterolemia
- Keywords
- hypercholesterolemia, postmenopause, secoisolariciresinol diglucoside, flaxseed, lignans, enterolactone, enterodiol, serum cholesterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Iowa State UniversityUniversity, hospital or other
- Collaborators
- Archer Daniels Midland Co.
- Study start
- Dec 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 14 Mar 2011 (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.
Purpose: To demonstrate the efficacy of Beneflax™ flaxseed lignan (SDG) concentrate to lower serum cholesterol levels.
Background: Flaxseed has been studied for various health benefits in humans, including prostate health, glucose control, and cardiovascular health. Cholesterol levels and high blood pressure are known to be risk factors for cardiovascular disease. Whole flaxseed has had variable effects on serum lipid levels, perhaps a consequence of variations in the amounts of secoisolariciresinol diglucoside (SDG) found in different flax cultivars, making the study of this bioactive compound difficult.
Hypothesis: Flaxseed lignan (SDG) extract (Beneflax) significantly lowers total and LDL cholesterol. Flaxseed lignans also lower blood pressure and fasting glucose levels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: secoisolariciresinol diglucoside-containing extract of flaxseedplacebo pill, diet counseling to comply with NCEP Step I diet |
| 150 mg/day Beneflax | Experimental | Dietary Supplement: secoisolariciresinol diglucoside-containing extract of flaxseed2 pills taken at breakfast and dinner containing a total of 150 mg secoisolariciresinol (SDG) per day for 12 weeks |
| 300 mg/day Beneflax | Experimental | Dietary Supplement: secoisolariciresinol diglucoside-containing extract of flaxseed2 pills taken at breakfast and dinner containing a total of 300 mg secoisolariciresinol (SDG) per day for 12 weeks |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men, 40-65 yrs/old, postmenopausal women 50-65 yrs/old not > 5 yrs post menopause. All subjects were hypercholesterolemic with either total cholesterol >240 mg/dl and < 320 mg/dL or LDL cholesterol >140 mg/dl and <190 mg/dl at the screening visit.
Key exclusion criteria (1 listed)
- Excluded subjects included diabetics, people being actively treated with niacins, fibrates, statins, insulin, ACE inhibitors or other cholesterol/ blood pressure pharmaceutical treatments, people who consumed large amounts of soy, flax, rye breads, pumpkin seeds, hydrolyzed milk products, sterols, and/or berries (strawberries/blueberries) or supplements aimed at cholesterol reduction such as spruce lignans, sytrinol (poly methoxylated flavanols), polycosinols, people consuming flaxseed on a regular basis.
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 |
|---|---|---|
| secoisolariciresinol diglucoside-containing extract of flaxseedAlso: Beneflax0, 150 or 300 mg/day as 2 pills taken at breakfast and dinner, dietary counseling to comply with NCEP Step I diet | Dietary supplement | 150 mg/day Beneflax, 300 mg/day Beneflax, placebo |
Primary outcome
Change in serum total cholesterol from baseline to 12 weeks after intervention treatments
Time frame: 12 weeks
Change in serum glucose from baseline to 12 weeks after intervention treatments
Time frame: 12 weeks
Change in blood pressure from baseline to end of treatment
Time frame: 12 weeks
1 secondary outcome
Changes in serum clinical chemistry from baseline to end of treatment
Time frame: 12 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 14 Mar 2011.
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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.
Suzanne Hendrich, PhD principal investigator
Iowa State 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 secoisolariciresinol diglucoside-containing extract of flaxseed in people with Hypercholesterolemia, run by Iowa State 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 1 inclusion and 1 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 14 Mar 2011. 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 serum total cholesterol from baseline to 12 weeks after intervention treatments (time frame: 12 weeks). 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 14 Mar 2011.