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Flax Muffins and Cholesterol Lowering

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ClinicalTrials.gov Identifier: NCT01821131
Recruitment Status : Active, not recruiting
First Posted : March 29, 2013
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
Agriculture and Agri-Food Canada
Information provided by (Responsible Party):
Dr. Heather Blewett, St. Boniface Hospital

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2014
Actual Primary Completion Date : November 2015
Estimated Study Completion Date : March 2020


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



Primary Outcome Measures :
  1. lipid profile [ Time Frame: 4 weeks ]
    plasma total cholesterol, HDL, LDL and triglycerides


Secondary Outcome Measures :
  1. flax metabolites [ Time Frame: 4 weeks ]
    plasma enterolignans and phospholipid fatty acid composition

  2. blood pressure [ Time Frame: 4 weeks ]
  3. high sensitivity c-reactive protein (hsCRP) [ Time Frame: 4 weeks ]
  4. glucose [ Time Frame: 4 weeks ]

Other Outcome Measures:
  1. 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.

  2. liver function [ Time Frame: 4 weeks ]
    plasma alanine aminotransferase (ALT) and aspartate aminotransferase (AST)

  3. kidney function [ Time Frame: 4 weeks ]
    plasma creatinine and urea

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01821131


Locations
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Canada, Manitoba
Asper Clinical Research Institute
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Ontario
Glycemic Index Laboratories Inc.
Toronto, Ontario, Canada, M5C 2N8
Sponsors and Collaborators
St. Boniface Hospital
Agriculture and Agri-Food Canada
Investigators
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Principal Investigator: Heather J Blewett, PhD Agriculture and Agri-Food Canada
Principal Investigator: Thomas Wolever, PhD, MD University of Toronto
Additional Information:
Publications:
Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, Carnethon MR, Dai S, de Simone G, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Greenlund KJ, Hailpern SM, Heit JA, Ho PM, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, McDermott MM, Meigs JB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Rosamond WD, Sorlie PD, Stafford RS, Turan TN, Turner MB, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2011 update: a report from the American Heart Association. Circulation. 2011 Feb 1;123(4):e18-e209. doi: 10.1161/CIR.0b013e3182009701. Epub 2010 Dec 15. Erratum in: Circulation. 2011 Feb 15;123(6):e240. Circulation. 2011 Oct 18;124(16):e426.

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Responsible Party: Dr. Heather Blewett, Principal Investigator, St. Boniface Hospital
ClinicalTrials.gov Identifier: NCT01821131    
Other Study ID Numbers: B2013:012
RRC/2013/1281 ( Other Identifier: Research Review Committee )
First Posted: March 29, 2013    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Keywords provided by Dr. Heather Blewett, St. Boniface Hospital:
flax
muffin
cholesterol
lignan
ALA