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muffin for High LDL 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

Select...

I am a man or a woman not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

lipid profile

Secondary outcome measures

blood pressure

flax metabolites

glucose

+1 more

Other outcome measures

Muffin acceptability questionnaire

gastrointestinal side effects

kidney function

+1 more

Trial 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Agriculture and Agri-Food CanadaOTHER_GOV

33 Previous Clinical Trials

2,229 Total Patients Enrolled

St. Boniface HospitalLead Sponsor

51 Previous Clinical Trials

11,533 Total Patients Enrolled

Heather J Blewett, PhDPrincipal InvestigatorAgriculture and Agri-Food Canada

2 Previous Clinical Trials

110 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 50 and above being enrolled in the research project?

"In order to be eligible for this medical trial, patients must have attained a minimum age of 30 and be below the threshold of 65."

Answered by AI

Are there currently opportunities to enroll in this trial?

"Clinicaltrials.gov reveals that this medical study, initially posted on January 1st 2014 and last updated October 24th 2022, is not recruiting participants at the moment. However there are presently one other trials actively seeking enrolment from patients."

Answered by AI

To whom is this trial open for enrollment?

"Patients falling between 30 and 65 years old that have elevated ldl levels are welcome to apply for this study. Those accepted must agree to comply with the conditions of the protocol, be either male or non-pregnant/non-lactating female, and also maintain a BMI of 18.5 - 40 kg/m2."

Answered by AI

Recent research and studies

CirculationJournal

Heart Disease and Stroke Statistics—2011 Update

Roger, Véronique L., Alan S. Go, Donald M. Lloyd-Jones, Robert J. Adams, Jarett D. Berry, Todd M. Brown, Mercedes R. Carnethon, et al.. 2011. “Heart Disease and Stroke Statistics—2011 Update”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/cir.0b013e3182009701.

clinicaltrials.govStudy

Flax Muffins and Cholesterol Lowering

Dr. Heather Blewett 2014. "Flax Muffins and Cholesterol Lowering". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01821131.

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