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Flaxseed Compared With Placebo in Patients With Hypercholesterolemia

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01007344
Enrollment
30
Registered
2009-11-04
Start date
2009-10-31
Completion date
2010-12-31
Last updated
2013-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial or Severe Hypercholesterolemia

Keywords

flaxseed, hypercholesterolemia, children

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTflaxseed

1 muffin for breakfast, 1 muffin for afternoon snack and 1 slice of bread for evening snack every day for 4 weeks

DIETARY_SUPPLEMENTwhole wheat flour

1 muffin for breakfast, 1 muffin for afternoon snack and 1 slice of bread for evening snack every day for 4 weeks

Sponsors

The Hospital for Sick Children
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
fasting serum total cholesterol, triglycerides, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) and C-reactive protein4 weeks

Secondary

MeasureTime frame
LH (luteinizing hormone, FSH (follicle-stimulating hormone), DHEA-S (Dihydroepiandrosterone sulfate), free testosterone, androstenedione4 weeks
complete blood count4 weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026