Flax Muffins and Cholesterol Lowering
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01821131 |
Recruitment Status :
Active, not recruiting
First Posted : March 29, 2013
Last Update Posted : September 25, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Above Optimal Plasma LDL Concentrations | Other: muffin | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 76 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | January 2014 |
Actual Primary Completion Date : | November 2015 |
Estimated Study Completion Date : | March 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: 30g ground flaxseed per day
consume 1 muffin containing 30g ground flaxseed every day for 4 weeks
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Other: muffin |
Experimental: 20g ground flaxseed per day
consume 1 muffin containing 20g ground flaxseed every day for 4 weeks
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Other: muffin |
Placebo Comparator: 0g ground flaxseed per day
consume 1 muffin containing 0g ground flaxseed every day for 4 weeks
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Other: muffin |
- lipid profile [ Time Frame: 4 weeks ]plasma total cholesterol, HDL, LDL and triglycerides
- flax metabolites [ Time Frame: 4 weeks ]plasma enterolignans and phospholipid fatty acid composition
- blood pressure [ Time Frame: 4 weeks ]
- high sensitivity c-reactive protein (hsCRP) [ Time Frame: 4 weeks ]
- glucose [ Time Frame: 4 weeks ]
- gastrointestinal side effects [ Time Frame: 4 weeks ]participants will be asked to document any abnormal gastrointestinal side effects (ie. abdominal bloating/swelling, flatulence, constipation, diarrhea, stomach pain, nausea, belching, vomiting, chocking/difficulty swallowing)in their study diary.
- liver function [ Time Frame: 4 weeks ]plasma alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
- kidney function [ Time Frame: 4 weeks ]plasma creatinine and urea
- Muffin acceptability questionnaire [ Time Frame: 4 weeks ]Questionnaire evaluating how much the participants liked or disliked the muffins in terms of color, aroma, flavor, texture, overall acceptability and frequency of eating of the muffin after the study is complete. The questionnaire will be administered at the end of each phase after the participant has been consuming the muffin every day for 4 weeks.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 30 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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))
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01821131
Canada, Manitoba | |
Asper Clinical Research Institute | |
Winnipeg, Manitoba, Canada, R2H 2A6 | |
Canada, Ontario | |
Glycemic Index Laboratories Inc. | |
Toronto, Ontario, Canada, M5C 2N8 |
Principal Investigator: | Heather J Blewett, PhD | Agriculture and Agri-Food Canada | |
Principal Investigator: | Thomas Wolever, PhD, MD | University of Toronto |
Publications:
Responsible Party: | Dr. Heather Blewett, Principal Investigator, St. Boniface Hospital |
ClinicalTrials.gov Identifier: | NCT01821131 |
Other Study ID Numbers: |
B2013:012 RRC/2013/1281 ( Other Identifier: Research Review Committee ) |
First Posted: | March 29, 2013 Key Record Dates |
Last Update Posted: | September 25, 2019 |
Last Verified: | September 2019 |
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