Flax Muffins and Cholesterol Lowering

January 31, 2024 updated by: Dr. Heather Blewett, St. Boniface Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • Asper Clinical Research Institute
    • Ontario
      • Toronto, Ontario, Canada, M5C 2N8
        • Glycemic Index Laboratories Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
gastrointestinal side effects
Time Frame: 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.
4 weeks
liver function
Time Frame: 4 weeks
plasma alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
4 weeks
kidney function
Time Frame: 4 weeks
plasma creatinine and urea
4 weeks
Muffin acceptability questionnaire
Time Frame: 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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Boniface Hospital

Collaborators

Agriculture and Agri-Food Canada

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

March 26, 2013

First Submitted That Met QC Criteria

March 26, 2013

First Posted (Estimated)

March 29, 2013

Study Record Updates

Last Update Posted (Actual)

February 2, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B2013:012
  • RRC/2013/1281 (Other Identifier: Research Review Committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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