Flax Muffins and Cholesterol Lowering

St. Boniface Hospital

Status: Active, not recruiting

Conditions: Above Optimal Plasma LDL Concentrations

Treatments: Other: muffin

Study type: Interventional

Funder types: Other

Identifiers

NCT01821131

RRC/2013/1281 (Other Identifier)

B2013:012

Details and patient eligibility

About

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.

Enrollment: 76 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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76 participants in 3 patient groups, including a placebo group

30g ground flaxseed per day

Experimental group

Description:

consume 1 muffin containing 30g ground flaxseed every day for 4 weeks

Treatment:

Other: muffin

20g ground flaxseed per day

Experimental group

Description:

consume 1 muffin containing 20g ground flaxseed every day for 4 weeks

Treatment:

Other: muffin

0g ground flaxseed per day

Placebo Comparator group

Description:

consume 1 muffin containing 0g ground flaxseed every day for 4 weeks

Treatment:

Other: muffin