Clinical trial NCT01821131: Flax Muffins and Cholesterol Lowering
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Above Optimal Plasma LDL Concentrations
Keywords: flax
muffin
cholesterol
lignan
ALA
Lead sponsor: St. Boniface Hospital
Sponsor class: OTHER
Collaborators: name: Agriculture and Agri-Food Canada
First posted: 2013-03-29
Enrollment: 76
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: lipid profile
timeFrame: 4 weeks
Secondary outcomes:
measure: flax metabolites
timeFrame: 4 weeks
measure: blood pressure
timeFrame: 4 weeks
measure: high sensitivity c-reactive protein (hsCRP)
timeFrame: 4 weeks
measure: glucose
timeFrame: 4 weeks
Other outcomes:
measure: gastrointestinal side effects
timeFrame: 4 weeks
measure: liver function
timeFrame: 4 weeks
measure: kidney function
timeFrame: 4 weeks
measure: Muffin acceptability questionnaire
timeFrame: 4 weeks
Locations:
city: Winnipeg
country: Canada
facility: Asper Clinical Research Institute
state: Manitoba
city: Toronto
country: Canada
facility: Glycemic Index Laboratories Inc.
state: Ontario
Study officials:
affiliation: Agriculture and Agri-Food Canada
name: Heather J Blewett, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Thomas Wolever, PhD, MD
role: PRINCIPAL_INVESTIGATOR
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