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Flax Muffins for High Cholesterol
N/A
Waitlist Available
Led By Heather J Blewett, PhD
Research Sponsored by St. Boniface Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male and non-pregnant/non-lactating female
Be older than 18 years old
Must not have
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 inflammatory disease (i.e., systemic lupus erythematosus, rheumatoid arthritis, psoriasis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Summary
This trialstudies how flax may lower "bad" cholesterol. It seeks the lowest dose of flax that can have this effect.
Who is the study for?
This trial is for adults with a BMI of 18.5-40 who have high LDL cholesterol levels (2.6-5.0 mmol/L) but no history of cardiovascular disease, diabetes, liver or kidney issues, and aren't on medications affecting blood lipids. They should eat regular meals and not be on weight loss programs or consume excessive alcohol.
What is being tested?
The study tests the effectiveness of flax muffins in lowering bad cholesterol (LDL). Participants will receive varying doses of flax to determine the minimum amount needed to reduce LDL levels without other interventions.
What are the potential side effects?
Potential side effects are not specified for eating flax muffins; however, typical reactions may include digestive changes like bloating or gas due to increased fiber intake from the flax.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man or a woman not pregnant or breastfeeding.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have diabetes or my fasting blood sugar is high, or I take medication to control my blood sugar.
Select...
I have a history of inflammatory diseases like lupus, arthritis, or psoriasis.
Select...
My liver tests are higher than normal.
Select...
I have a history of kidney disease or my kidney tests are not normal.
Select...
I have not had major surgery in the last 3 months.
Select...
My weight has been stable; I haven't lost or gained more than 5% in the last 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
lipid profile
Secondary study objectives
flax metabolites
Other study objectives
Muffin acceptability questionnaire
gastrointestinal side effects
kidney function
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: 30g ground flaxseed per dayExperimental Treatment1 Intervention
consume 1 muffin containing 30g ground flaxseed every day for 4 weeks
Group II: 20g ground flaxseed per dayExperimental Treatment1 Intervention
consume 1 muffin containing 20g ground flaxseed every day for 4 weeks
Group III: 0g ground flaxseed per dayPlacebo Group1 Intervention
consume 1 muffin containing 0g ground flaxseed every day for 4 weeks
Find a Location
Who is running the clinical trial?
Agriculture and Agri-Food CanadaOTHER_GOV
34 Previous Clinical Trials
2,241 Total Patients Enrolled
St. Boniface HospitalLead Sponsor
54 Previous Clinical Trials
14,958 Total Patients Enrolled
Heather J Blewett, PhDPrincipal InvestigatorAgriculture and Agri-Food Canada
2 Previous Clinical Trials
110 Total Patients Enrolled
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