Status:
ACTIVE_NOT_RECRUITING
Flax Muffins and Cholesterol Lowering
Lead Sponsor:
St. Boniface Hospital
Collaborating Sponsors:
Agriculture and Agri-Food Canada
Conditions:
Above Optimal Plasma LDL Concentrations
Eligibility:
All Genders
30-65 years
Phase:
NA
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01821131
Start Date
January 1 2014
End Date
January 1 2025
Last Update
February 2 2024
Active Locations (2)
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1
Asper Clinical Research Institute
Winnipeg, Manitoba, Canada, R2H 2A6
2
Glycemic Index Laboratories Inc.
Toronto, Ontario, Canada, M5C 2N8