76 Participants Needed

Flax Muffins for High Cholesterol

Recruiting at 1 trial location

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

HJ

Heather J Blewett, PhD

Principal Investigator

Agriculture and Agri-Food Canada

TW

Thomas Wolever, PhD, MD

Principal Investigator

University of Toronto

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Body mass index 18.5-40.0 kg/m2
Fasting plasma LDL cholesterol 2.6-5.0 mmol/L
Willing to comply with protocol requirements
See 3 more

Exclusion Criteria

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
I have a history of heart disease or take medication for cholesterol or blood pressure.
Fasting plasma triglycerides ≥ 4.0 mmol/L
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume muffins containing varying doses of ground flaxseed daily to study LDL cholesterol lowering effects

4 weeks
Daily consumption

Follow-up

Participants are monitored for safety and effectiveness after treatment, including gastrointestinal side effects, liver and kidney function, and lipid profile

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Flax Muffin
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: 30g ground flaxseed per dayExperimental Treatment1 Intervention
Group II: 20g ground flaxseed per dayExperimental Treatment1 Intervention
Group III: 0g ground flaxseed per dayPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

St. Boniface Hospital

Lead Sponsor

Trials
55
Recruited
15,000+

Agriculture and Agri-Food Canada

Collaborator

Trials
35
Recruited
2,300+
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