Flax Muffins and Cholesterol Lowering

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Above Optimal Plasma LDL Concentrations

Intervention / Treatment
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* Other: muffin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 30g ground flaxseed per day<br>consume 1 muffin containing 30g ground flaxseed every day for 4 weeks | Other: muffin<br> <br> |
| Experimental: 20g ground flaxseed per day<br>consume 1 muffin containing 20g ground flaxseed every day for 4 weeks | Other: muffin<br> <br> |
| Placebo Comparator: 0g ground flaxseed per day<br>consume 1 muffin containing 0g ground flaxseed every day for 4 weeks | Other: muffin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipid profile | plasma total cholesterol, HDL, LDL and triglycerides | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| flax metabolites | plasma enterolignans and phospholipid fatty acid composition | 4 weeks | 
| blood pressure |  | 4 weeks | 
| high sensitivity c-reactive protein (hsCRP) |  | 4 weeks | 
| glucose |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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flax, muffin, cholesterol, lignan, ALA