Flax Muffins and Cholesterol Lowering

NCT01821131 | Unknown

• 2 other identifiers: B2013:012RRC/2013/1281
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

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.

Conditions

Above Optimal Plasma LDL Concentrations

Keywords

flax; muffin; cholesterol; lignan; ALA

Outcome Measures

Primary Outcomes (1)

• lipid profile

  plasma total cholesterol, HDL, LDL and triglycerides

  4 weeks

Secondary Outcomes (4)

• flax metabolites

  4 weeks

• blood pressure

  4 weeks

• high sensitivity c-reactive protein (hsCRP)

  4 weeks

• glucose

  4 weeks

Other Outcomes (4)

• gastrointestinal side effects

  4 weeks

• liver function

  4 weeks

• kidney function

  4 weeks

Study Arms (3)

30g ground flaxseed per day

EXPERIMENTAL

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

Other: muffin

20g ground flaxseed per day

EXPERIMENTAL

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

Other: muffin

0g ground flaxseed per day

PLACEBO COMPARATOR

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

Other: muffin

Interventions

muffin OTHER

0g ground flaxseed per day; 20g ground flaxseed per day; 30g ground flaxseed per day

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Boniface Hospital: lead
• Agriculture and Agri-Food Canada: collaborator

Study Sites (2)

Asper Clinical Research Institute

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Glycemic Index Laboratories Inc.

Toronto, Ontario, M5C 2N8, Canada

Location

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Related Links

• Canadian health measures survey: Heart health and cholesterol levels of Canadians, 2007-2009

Study Officials

• Heather J Blewett, PhD

  Agriculture and Agri-Food Canada

  PRINCIPAL INVESTIGATOR

• Thomas Wolever, PhD, MD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2013
• First Posted: March 29, 2013
• Study Start: January 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: January 1, 2025
• Last Updated: February 2, 2024

Record last verified: 2024-01

Locations

CA (2)