Above Optimal Plasma LDL ConcentrationsNCT01821131

Flax Muffins and Cholesterol Lowering

A study testing muffin in people with Above Optimal Plasma LDL Concentrations, run by St. Boniface Hospital at 2 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This Clinical Trial is being conducted to study the LDL (bad) cholesterol lowering abilities of flax. The purpose of this study is to find the lowest dose of flax that can lower LDL-cholesterol. Read more about this study

Who is it for?: Ages 30 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Above Optimal Plasma LDL Concentrations
What is being tested?: muffin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 76 participants
Where: 2 sitesCanada
Study dates: Jan 2014to Jan 2025
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 30 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

male and non-pregnant/non-lactating female
Body mass index 18.5-40.0 kg/m2
Fasting plasma LDL cholesterol 2.6-5.0 mmol/L
Regular dietary habits (ie. breakfast, lunch and dinner meals consumed daily)
Willing to comply with protocol requirements
Willing to provide informed consent

Who cannot join

Medical history of cardiovascular disease, use of cholesterol-lowering or blood pressure-lowering medications
Fasting plasma triglycerides ≥ 4.0 mmol/L
Medical history of diabetes mellitus, fasting plasma glucose ≥ 7.0 mmol/L or use of insulin or oral medication to control blood sugar
Medical history of gastrointestinal disease, daily use of any stomach acid-lowering medications or laxatives (including fibre supplements) within the past month or antibiotic use within the past 6 weeks
Medical history of inflammatory disease (ie. Systemic lupus erythematosis, rheumatoid arthritis, psoriasis)
Medical history of liver disease or liver dysfunction (defined as plasma AST or ALT ≥ 1.5 times the upper limit of normal (ULN))

Show all 17Show fewer

Medical history of kidney disease or kidney dysfunction (defined as blood urea nitrogen and creatinine ≥ 1.8 times the ULN)
Active treatment for any type of cancer within 1 year prior to study start
Major surgery within the last 3 months
Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
Unstable body weight (defined as > 5% change in 3 months) or actively participating in a weight loss program
Tobacco and/or nicotine replacement use, current or within the last 3 months
Taking medication (prescription or non-prescription) or dietary supplements (pre/probiotics, vitamins, minerals, fats, herbals) known to affect blood lipids, with the exception of stable doses of thyroxine and oral contraceptive agents
Any food allergy, aversion or unwillingness to eat wheat or flax
Daily consumption of flax containing products in the past month
Regular intake of > 2 alcoholic drinks per day. Standard drink (13.6 g alcohol)= Beer (5% alcohol) 360 mL (12 fl.oz); Spirits (40% alcohol) 45 mL (1.5 fl.oz); wine (12% alcohol) 150 mL (5 fl.oz)
Participation in another clinical trial, current or in the past 4 weeks

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

Glycemic Index Laboratories Inc.
Toronto, Ontario, M5C 2N8
Asper Clinical Research Institute
Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

About this study

Official title: A Dose Response, Randomized, Controlled, Double-blind, Cross-over Trial to Determine the LDL Cholesterol Lowering Effect of Ground Flaxseed in Adults With Above Optimal Plasma LDL Concentrations

This Clinical Trial is being conducted to study the LDL (bad) cholesterol lowering abilities of flax. The purpose of this study is to find the lowest dose of flax that can lower LDL-cholesterol.

Conditions: Above Optimal Plasma LDL Concentrations
Being tested: muffin
Keywords: flax, muffin, cholesterol, lignan, ALA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

muffinOther

Study groups in NCT01821131
Study group	Role	What they receive
30g ground flaxseed per day	Experimental	consume 1 muffin containing 30g ground flaxseed every day for 4 weeks Receives: Other: muffin
20g ground flaxseed per day	Experimental	consume 1 muffin containing 20g ground flaxseed every day for 4 weeks Receives: Other: muffin
0g ground flaxseed per day	Placebo comparator	consume 1 muffin containing 0g ground flaxseed every day for 4 weeks Receives: Other: muffin

What is being measured

The primary outcome is the main question the study is designed to answer.

lipid profile
plasma total cholesterol, HDL, LDL and triglycerides
Measured: 4 weeks

Secondary outcomes (4)

flax metabolites
plasma enterolignans and phospholipid fatty acid composition
Measured: 4 weeks
blood pressure
Measured: 4 weeks
high sensitivity c-reactive protein (hsCRP)
Measured: 4 weeks
glucose
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Jan 2025

First posted29 Mar 2013 (estimated)
Study startJan 2014
Primary completionNov 2015
Study completionJan 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for Above Optimal Plasma LDL ConcentrationsStudies 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 76 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01821131
Sponsor's protocol ID: B2013:012
Other IDs: RRC/2013/1281
Status last verified: Jan 2024
First submitted: 26 Mar 2013
Last updated: 2 Feb 2024
Results posted: No
Data monitoring committee: No

Publications

Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, Carnethon MR, Dai S, de Simone G, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Greenlund KJ, Hailpern SM, Heit JA, Ho PM, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, McDermott MM, Meigs JB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Rosamond WD, Sorlie PD, Stafford RS, Turan TN, Turner MB, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2011 update: a report from the American Heart Association. Circulation. 2011 Feb 1;123(4):e18-e209. doi: 10.1161/CIR.0b013e3182009701. Epub 2010 Dec 15.
PubMed 21160056
Genest J, McPherson R, Frohlich J, Anderson T, Campbell N, Carpentier A, Couture P, Dufour R, Fodor G, Francis GA, Grover S, Gupta M, Hegele RA, Lau DC, Leiter L, Lewis GF, Lonn E, Mancini GB, Ng D, Pearson GJ, Sniderman A, Stone JA, Ur E. 2009 Canadian Cardiovascular Society/Canadian guidelines for the diagnosis and treatment of dyslipidemia and prevention of cardiovascular disease in the adult - 2009 recommendations. Can J Cardiol. 2009 Oct;25(10):567-79. doi: 10.1016/s0828-282x(09)70715-9.
PubMed 19812802
Charland SL, Cziraky MJ, Quimbo R, Karas RH, Insull W Jr, Davidson M, Stanek EJ. Achieving optimal lipid values in patients with dyslipidemia is associated with reduced risk of cardiovascular events. J Clin Lipidol. 2008 Oct;2(5):343-53. doi: 10.1016/j.jacl.2008.06.009. Epub 2008 Jun 26.
PubMed 21291759
Lusis AJ. Atherosclerosis. Nature. 2000 Sep 14;407(6801):233-41. doi: 10.1038/35025203.
PubMed 11001066
O'Rourke MF, Staessen JA, Vlachopoulos C, Duprez D, Plante GE. Clinical applications of arterial stiffness; definitions and reference values. Am J Hypertens. 2002 May;15(5):426-44. doi: 10.1016/s0895-7061(01)02319-6.
PubMed 12022246
Xu Y, Wu Y, Li J, Ma W, Guo X, Luo Y, Hu D. The predictive value of brachial-ankle pulse wave velocity in coronary atherosclerosis and peripheral artery diseases in urban Chinese patients. Hypertens Res. 2008 Jun;31(6):1079-85. doi: 10.1291/hypres.31.1079.
PubMed 18716354
Leng GC, Fowkes FG, Lee AJ, Dunbar J, Housley E, Ruckley CV. Use of ankle brachial pressure index to predict cardiovascular events and death: a cohort study. BMJ. 1996 Dec 7;313(7070):1440-4. doi: 10.1136/bmj.313.7070.1440.
PubMed 8973232
Murabito JM, Evans JC, Larson MG, Nieto K, Levy D, Wilson PW; Framingham Study. The ankle-brachial index in the elderly and risk of stroke, coronary disease, and death: the Framingham Study. Arch Intern Med. 2003 Sep 8;163(16):1939-42. doi: 10.1001/archinte.163.16.1939.
PubMed 12963567
Singh KK, Mridula D, Rehal J, Barnwal P. Flaxseed: a potential source of food, feed and fiber. Crit Rev Food Sci Nutr. 2011 Mar;51(3):210-22. doi: 10.1080/10408390903537241.
PubMed 21390942
Bassett CM, Rodriguez-Leyva D, Pierce GN. Experimental and clinical research findings on the cardiovascular benefits of consuming flaxseed. Appl Physiol Nutr Metab. 2009 Oct;34(5):965-74. doi: 10.1139/H09-087.
PubMed 19935863
Austria JA, Richard MN, Chahine MN, Edel AL, Malcolmson LJ, Dupasquier CM, Pierce GN. Bioavailability of alpha-linolenic acid in subjects after ingestion of three different forms of flaxseed. J Am Coll Nutr. 2008 Apr;27(2):214-21. doi: 10.1080/07315724.2008.10719693.
PubMed 18689552
Zhang W, Wang X, Liu Y, Tian H, Flickinger B, Empie MW, Sun SZ. Dietary flaxseed lignan extract lowers plasma cholesterol and glucose concentrations in hypercholesterolaemic subjects. Br J Nutr. 2008 Jun;99(6):1301-9. doi: 10.1017/S0007114507871649. Epub 2007 Dec 6.
PubMed 18053310
Othman RA, Moghadasian MH, Jones PJ. Cholesterol-lowering effects of oat beta-glucan. Nutr Rev. 2011 Jun;69(6):299-309. doi: 10.1111/j.1753-4887.2011.00401.x.
PubMed 21631511
Bloedon LT, Balikai S, Chittams J, Cunnane SC, Berlin JA, Rader DJ, Szapary PO. Flaxseed and cardiovascular risk factors: results from a double blind, randomized, controlled clinical trial. J Am Coll Nutr. 2008 Feb;27(1):65-74. doi: 10.1080/07315724.2008.10719676.
PubMed 18460483
Cunnane SC, Hamadeh MJ, Liede AC, Thompson LU, Wolever TM, Jenkins DJ. Nutritional attributes of traditional flaxseed in healthy young adults. Am J Clin Nutr. 1995 Jan;61(1):62-8. doi: 10.1093/ajcn/61.1.62.
PubMed 7825540

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Dose Response, Randomized, Controlled, Double-blind, Cross-over Trial to Determine the LDL Cholesterol Lowering Effect of Ground Flaxseed in Adults With Above Optimal Plasma LDL Concentrations
ClinicalTrials.gov ID: NCT01821131
Acronym / sponsor ID: B2013:012
Conditions: Above Optimal Plasma LDL Concentrations
Keywords: flax, muffin, cholesterol, lignan, ALA
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 76 participants (estimated)
Lead sponsor: St. Boniface HospitalUniversity, hospital or other
Collaborators: Agriculture and Agri-Food Canada
Study start: Jan 2014 (actual)
Primary completion: Nov 2015 (actual)
Study completion: Jan 2025 (estimated)
First posted: 29 Mar 2013 (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.

This Clinical Trial is being conducted to study the LDL (bad) cholesterol lowering abilities of flax. The purpose of this study is to find the lowest dose of flax that can lower LDL-cholesterol.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
30g ground flaxseed per day	Experimental	Other: muffinconsume 1 muffin containing 30g ground flaxseed every day for 4 weeks
20g ground flaxseed per day	Experimental	Other: muffinconsume 1 muffin containing 20g ground flaxseed every day for 4 weeks
0g ground flaxseed per day	Placebo comparator	Other: muffinconsume 1 muffin containing 0g ground flaxseed every day for 4 weeks

Who may qualify

Ages: 30 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

male and non-pregnant/non-lactating female
Body mass index 18.5-40.0 kg/m2
Fasting plasma LDL cholesterol 2.6-5.0 mmol/L
Regular dietary habits (ie. breakfast, lunch and dinner meals consumed daily)
Willing to comply with protocol requirements

Key exclusion criteria (17 listed)

Medical history of cardiovascular disease, use of cholesterol-lowering or blood pressure-lowering medications
Fasting plasma triglycerides ≥ 4.0 mmol/L
Medical history of diabetes mellitus, fasting plasma glucose ≥ 7.0 mmol/L or use of insulin or oral medication to control blood sugar
Medical history of gastrointestinal disease, daily use of any stomach acid-lowering medications or laxatives (including fibre supplements) within the past month or antibiotic use within the past 6 weeks
Medical history of inflammatory disease (ie. Systemic lupus erythematosis, rheumatoid arthritis, psoriasis)

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
muffin	Other	0g ground flaxseed per day, 20g ground flaxseed per day, 30g ground flaxseed per day

Primary outcome

lipid profile
Time frame: 4 weeks
plasma total cholesterol, HDL, LDL and triglycerides

4 secondary outcomes

flax metabolites
Time frame: 4 weeks
blood pressure
Time frame: 4 weeks
high sensitivity c-reactive protein (hsCRP)
Time frame: 4 weeks
glucose
Time frame: 4 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
Background: PubMed 21160056Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, Carnethon MR, Dai S, de Simone G, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Greenlund KJ, Hailpern SM, Heit JA, Ho PM, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, McDermott MM, Meigs JB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Rosamond WD, Sorlie PD, Stafford RS, Turan TN, Turner MB, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2011 update: a report from the American Heart Association. Circulation. 2011 Feb 1;123(4):e18-e209. doi: 10.1161/CIR.0b013e3182009701. Epub 2010 Dec 15.
Background: PubMed 19812802Genest J, McPherson R, Frohlich J, Anderson T, Campbell N, Carpentier A, Couture P, Dufour R, Fodor G, Francis GA, Grover S, Gupta M, Hegele RA, Lau DC, Leiter L, Lewis GF, Lonn E, Mancini GB, Ng D, Pearson GJ, Sniderman A, Stone JA, Ur E. 2009 Canadian Cardiovascular Society/Canadian guidelines for the diagnosis and treatment of dyslipidemia and prevention of cardiovascular disease in the adult - 2009 recommendations. Can J Cardiol. 2009 Oct;25(10):567-79. doi: 10.1016/s0828-282x(09)70715-9.
Background: PubMed 21291759Charland SL, Cziraky MJ, Quimbo R, Karas RH, Insull W Jr, Davidson M, Stanek EJ. Achieving optimal lipid values in patients with dyslipidemia is associated with reduced risk of cardiovascular events. J Clin Lipidol. 2008 Oct;2(5):343-53. doi: 10.1016/j.jacl.2008.06.009. Epub 2008 Jun 26.
Background: PubMed 11001066Lusis AJ. Atherosclerosis. Nature. 2000 Sep 14;407(6801):233-41. doi: 10.1038/35025203.
Background: PubMed 12022246O'Rourke MF, Staessen JA, Vlachopoulos C, Duprez D, Plante GE. Clinical applications of arterial stiffness; definitions and reference values. Am J Hypertens. 2002 May;15(5):426-44. doi: 10.1016/s0895-7061(01)02319-6.
Background: PubMed 18716354Xu Y, Wu Y, Li J, Ma W, Guo X, Luo Y, Hu D. The predictive value of brachial-ankle pulse wave velocity in coronary atherosclerosis and peripheral artery diseases in urban Chinese patients. Hypertens Res. 2008 Jun;31(6):1079-85. doi: 10.1291/hypres.31.1079.
Background: PubMed 8973232Leng GC, Fowkes FG, Lee AJ, Dunbar J, Housley E, Ruckley CV. Use of ankle brachial pressure index to predict cardiovascular events and death: a cohort study. BMJ. 1996 Dec 7;313(7070):1440-4. doi: 10.1136/bmj.313.7070.1440.
Background: PubMed 12963567Murabito JM, Evans JC, Larson MG, Nieto K, Levy D, Wilson PW; Framingham Study. The ankle-brachial index in the elderly and risk of stroke, coronary disease, and death: the Framingham Study. Arch Intern Med. 2003 Sep 8;163(16):1939-42. doi: 10.1001/archinte.163.16.1939.
Background: PubMed 21390942Singh KK, Mridula D, Rehal J, Barnwal P. Flaxseed: a potential source of food, feed and fiber. Crit Rev Food Sci Nutr. 2011 Mar;51(3):210-22. doi: 10.1080/10408390903537241.
Background: PubMed 19935863Bassett CM, Rodriguez-Leyva D, Pierce GN. Experimental and clinical research findings on the cardiovascular benefits of consuming flaxseed. Appl Physiol Nutr Metab. 2009 Oct;34(5):965-74. doi: 10.1139/H09-087.
Background: PubMed 18689552Austria JA, Richard MN, Chahine MN, Edel AL, Malcolmson LJ, Dupasquier CM, Pierce GN. Bioavailability of alpha-linolenic acid in subjects after ingestion of three different forms of flaxseed. J Am Coll Nutr. 2008 Apr;27(2):214-21. doi: 10.1080/07315724.2008.10719693.
Background: PubMed 18053310Zhang W, Wang X, Liu Y, Tian H, Flickinger B, Empie MW, Sun SZ. Dietary flaxseed lignan extract lowers plasma cholesterol and glucose concentrations in hypercholesterolaemic subjects. Br J Nutr. 2008 Jun;99(6):1301-9. doi: 10.1017/S0007114507871649. Epub 2007 Dec 6.
Canadian health measures survey: Heart health and cholesterol levels of Canadians, 2007-2009Link provided by the sponsor.

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.

Heather J Blewett, PhD principal investigator

Agriculture and Agri-Food Canada

Thomas Wolever, PhD, MD principal investigator

University of Toronto

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing muffin in people with Above Optimal Plasma LDL Concentrations, run by St. Boniface Hospital at 2 sites in Canada.

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 6 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. 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?

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?

lipid profile (time frame: 4 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 NCT01821131, which also lists 20 linked publications.

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 2 Feb 2024.