Flax Muffins for High Cholesterol

Not currently recruiting at 1 trial location

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well flax muffins can lower LDL cholesterol, often called "bad" cholesterol. The researchers aim to determine the smallest effective amount of flax. Participants will be divided into groups, with some eating muffins containing varying amounts of flax each day for four weeks. The trial seeks individuals with stable eating habits and moderately high LDL cholesterol who are not on cholesterol or blood pressure medications. As an unphased trial, participation offers a chance to contribute to understanding dietary impacts on cholesterol.

Will I have to stop taking my current medications?

If you are taking cholesterol-lowering or blood pressure-lowering medications, or any medication known to affect blood lipids, you would not be eligible for this trial. The protocol does not specify about other medications, but you should discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that flaxseed often helps with health issues like high cholesterol, diabetes, and weight problems. Studies have found that flaxseed can improve health indicators such as blood pressure and cholesterol, suggesting it is likely safe for many people.

Flaxseed contains omega-3 fatty acids, which benefit heart health. Some people might experience mild side effects, such as bloating or gas, but these are usually not serious. Since this trial tests different amounts of flaxseed in muffins, it appears safe based on existing knowledge about flaxseed.

In summary, flaxseed is generally well-tolerated, but it's always important to monitor how the body reacts.12345

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for high cholesterol, which often include statins and lifestyle changes, flax muffins offer a unique approach by using ground flaxseed as the active ingredient. Flaxseed is rich in omega-3 fatty acids and fiber, both of which are believed to help reduce cholesterol levels naturally. Researchers are excited about this treatment because it provides a simple, dietary alternative that could appeal to those seeking natural or non-pharmaceutical options. Plus, incorporating flaxseed into a daily diet through something as accessible as a muffin could make it easier for people to stick with their treatment plan.

What evidence suggests that flax muffins could be effective for lowering high cholesterol?

Research has shown that flaxseed can help lower LDL cholesterol, often referred to as "bad" cholesterol. Studies have found that consuming flaxseed significantly reduces LDL levels. In one study, participants who ate flaxseed had lower cholesterol than those who did not. Another study found that flaxseed not only lowered LDL cholesterol but also reduced total cholesterol and triglycerides, which are fats in the blood. These findings suggest that flaxseed may effectively lower cholesterol levels. This trial will compare the effects of consuming muffins with different amounts of ground flaxseed—0g, 20g, and 30g per day—on cholesterol levels.16789

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

Citations

Study Details | Flax Muffins and Cholesterol LoweringThis 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 Muffins and Cholesterol LoweringThis Clinical Trial is being conducted to study the LDL (bad) cholesterol lowering abilities of flax. The purpose of this study is to find ...
Meta-analysis of the effects of flaxseed interventions on ...Conclusions: Flaxseed significantly reduced circulating total and LDL-cholesterol concentrations, but the changes were dependent on the type of intervention, ...
Flaxseed Compared With Placebo in Patients ...Two muffins and one slice of bread will be consumed per day to provide a total of 30g flaxseed to the experimental group. The control group will be given ...
Clinical, nutritional, and quality assessment of flaxseeds ...Results revealed that blood glucose, triglycerides, total cholesterol, and low-density lipoprotein cholesterol were significantly reduced, ...
The Impacts of Standardized Flaxseed Meal (XanFlax) on ...This study marks the first time a standardized flaxseed gum product, XanFlax, has been described in a functional baking application.
Flaxseed - Uses, Side Effects, and MoreFlaxseed is used for constipation, diabetes, high cholesterol, obesity, and swelling of the kidneys in people with lupus.
The effects of flaxseed supplementation on metabolic ...Flaxseed supplementation significantly improves metabolic syndrome markers, including BMI, blood pressure, lipid profile, and glycemic indices.
Flaxseed in Diet: A Comprehensive Look at Pros and ConsResearch has shown that ALA, an omega-3 fatty acid, can help reduce blood pressure, lower cholesterol levels, and improve overall heart health, while lignans ...
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