Overview

This trial is active, not recruiting.

Condition above optimal plasma ldl concentrations
Treatment muffin
Sponsor St. Boniface General Hospital Research Centre
Collaborator Agriculture and Agri-Food Canada
Start date January 2014
End date November 2015
Trial size 76 participants
Trial identifier NCT01821131, B2013:012, RRC/2013/1281

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
consume 1 muffin containing 30g ground flaxseed every day for 4 weeks
muffin
(Experimental)
consume 1 muffin containing 20g ground flaxseed every day for 4 weeks
muffin
(Placebo Comparator)
consume 1 muffin containing 0g ground flaxseed every day for 4 weeks
muffin

Primary Outcomes

Measure
lipid profile
time frame: 4 weeks

Secondary Outcomes

Measure
flax metabolites
time frame: 4 weeks
blood pressure
time frame: 4 weeks
high sensitivity c-reactive protein (hsCRP)
time frame: 4 weeks
glucose
time frame: 4 weeks

Eligibility Criteria

Male or female participants from 30 years up to 65 years old.

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

Additional Information

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
Principal investigator Heather J Blewett, PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by St. Boniface General Hospital Research Centre.