Above Optimal Plasma LDL Concentrations Clinical Trial
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
| Verified date | January 2024 |
| Source | St. Boniface Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 76 |
| Est. completion date | January 2025 |
| Est. primary completion date | November 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 30 Years to 65 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Glycemic Index Laboratories Inc. | Toronto | Ontario |
| Canada | Asper Clinical Research Institute | Winnipeg | Manitoba |
| Lead Sponsor | Collaborator |
|---|---|
| St. Boniface Hospital | Agriculture and Agri-Food Canada |
Canada,
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* Note: There are 20 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | gastrointestinal side effects | 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 | |
| Other | liver function | plasma alanine aminotransferase (ALT) and aspartate aminotransferase (AST) | 4 weeks | |
| Other | kidney function | plasma creatinine and urea | 4 weeks | |
| Other | Muffin acceptability questionnaire | 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 | |
| Primary | lipid profile | plasma total cholesterol, HDL, LDL and triglycerides | 4 weeks | |
| Secondary | flax metabolites | plasma enterolignans and phospholipid fatty acid composition | 4 weeks | |
| Secondary | blood pressure | 4 weeks | ||
| Secondary | high sensitivity c-reactive protein (hsCRP) | 4 weeks | ||
| Secondary | glucose | 4 weeks |