Flax Muffins and Cholesterol Lowering

Sponsor

St. Boniface Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01821131

Collaborator

Agriculture and Agri-Food Canada (Other)

Enrollment

Locations

Arms

104

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Above Optimal Plasma LDL Concentrations	Other: muffin	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Jan 1, 2014

Actual Primary Completion Date :

Nov 1, 2015

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 30g ground flaxseed per day consume 1 muffin containing 30g ground flaxseed every day for 4 weeks	Other: muffin
Experimental: 20g ground flaxseed per day consume 1 muffin containing 20g ground flaxseed every day for 4 weeks	Other: muffin
Placebo Comparator: 0g ground flaxseed per day consume 1 muffin containing 0g ground flaxseed every day for 4 weeks	Other: muffin

Arm

Intervention/Treatment

Experimental: 30g ground flaxseed per day

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

Other: muffin

Experimental: 20g ground flaxseed per day

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

Other: muffin

Placebo Comparator: 0g ground flaxseed per day

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

Other: muffin

Outcome Measures

Primary Outcome Measures

lipid profile [4 weeks]
plasma total cholesterol, HDL, LDL and triglycerides

Secondary Outcome Measures

flax metabolites [4 weeks]
plasma enterolignans and phospholipid fatty acid composition
blood pressure [4 weeks]
high sensitivity c-reactive protein (hsCRP) [4 weeks]
glucose [4 weeks]

Other Outcome Measures

gastrointestinal side effects [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 [4 weeks]
plasma alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
kidney function [4 weeks]
plasma creatinine and urea
Muffin acceptability questionnaire [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asper Clinical Research Institute	Winnipeg	Manitoba	Canada	R2H 2A6
2	Glycemic Index Laboratories Inc.	Toronto	Ontario	Canada	M5C 2N8

Sponsors and Collaborators

St. Boniface Hospital
Agriculture and Agri-Food Canada

Investigators

Principal Investigator: Heather J Blewett, PhD, Agriculture and Agri-Food Canada
Principal Investigator: Thomas Wolever, PhD, MD, University of Toronto