Flax Muffins for High Cholesterol

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Boniface Hospital

Must not be taking: Cholesterol-lowering, Blood pressure-lowering, Insulin, Laxatives

Disqualifiers: Cardiovascular disease, Diabetes, Gastrointestinal disease, Inflammatory disease, others

Compensation: Varies

Number of Visits: Unknown

76 Participants Needed

Trial Summary

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.

Research Team

Heather J Blewett, PhD

Principal Investigator

Agriculture and Agri-Food Canada

Thomas Wolever, PhD, MD

Principal Investigator

University of Toronto

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: 30g ground flaxseed per day Experimental Treatment 1 Intervention

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

Group II: 20g ground flaxseed per day Experimental Treatment 1 Intervention

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

Group III: 0g ground flaxseed per day Placebo Group 1 Intervention

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

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+