Flaxseed Compared With Placebo in Patients With Hypercholesterolemia

Study Overview
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Brief Summary
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The aim of this study is to determine if thirty grams per day of flaxseed consumption for 4 weeks could potentially reduce the serum lipid levels in children and adolescents with familial or severe hypercholesterolemia compared to those on placebo.

Detailed Description
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The proposed study is a 4 week randomized, double-blind, placebo-controlled clinical trial. Participants will be recruited from the pediatric lipid disorder clinic at the Hospital for Sick Children, which provides consultations to and management of children with primary lipid abnormalities. Patients that meet the study criteria will be approached during their routinely scheduled clinic visits, until the sample size (N=30) be reached. Patients will randomly be assigned to the intervention or the placebo group. The intervention group will be given muffins and breads containing ground flaxseed. 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 muffins and breads containing whole wheat flour in place of flaxseed. Participants will be instructed to eat one muffin for breakfast, one muffin as an afternoon snack, and one slice of bread as an evening snack every day for a 4-week period. The muffins and breads use in the study will be baked by an independent baker.

Official Title
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A 4-week Study in Children and Adolescents With Familial or Severe Hypercholesterolemia Comparing Flaxseed Therapy to Placebo

Conditions
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Familial or Severe Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: flaxseed
* Dietary Supplement: whole wheat flour


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 8 to 18 years positive first-degree family history of hypercholesterolemia or premature atherosclerotic cardiovascular disease elevated LDL level above 3.5 mmol/L and less than 5.0 mmol/L entered in the National Cholesterol Education Program Step II diet for at least 6 months Exclusion Criteria: patients with secondary causes of hyperlipidemia history of major illness or surgery 3 months or less prior to enrollment taking lipid-lowering medications history of gastrointestinal problems allergies towards flaxseed

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: flaxseed<br>2 muffins and 1 slice of bread for a total of 30g flaxseed per day | Dietary Supplement: flaxseed<br>* 1 muffin for breakfast, 1 muffin for afternoon snack and 1 slice of bread for evening snack every day for 4 weeks<br>|
| Placebo Comparator: whole wheat flour<br>2 muffins and 1 slice of bread containing whole wheat flour per day | Dietary Supplement: whole wheat flour<br>* 1 muffin for breakfast, 1 muffin for afternoon snack and 1 slice of bread for evening snack every day for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting serum total cholesterol, triglycerides, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) and C-reactive protein |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LH (luteinizing hormone, FSH (follicle-stimulating hormone), DHEA-S (Dihydroepiandrosterone sulfate), free testosterone, androstenedione |  | 4 weeks | 
| complete blood count |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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flaxseed, hypercholesterolemia, children