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Flaxseed Compared With Placebo in Patients With Hypercholesterolemia

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ClinicalTrials.gov Identifier: NCT01007344
Recruitment Status : Completed
First Posted : November 4, 2009
Last Update Posted : August 27, 2013
Sponsor:
Information provided by (Responsible Party):
Brian McCrindle, The Hospital for Sick 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.

Condition or disease Intervention/treatment Phase
Familial or Severe Hypercholesterolemia Dietary Supplement: flaxseed Dietary Supplement: whole wheat flour Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A 4-week Study in Children and Adolescents With Familial or Severe Hypercholesterolemia Comparing Flaxseed Therapy to Placebo
Study Start Date : October 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: flaxseed
2 muffins and 1 slice of bread for a total of 30g flaxseed per day
Dietary Supplement: flaxseed
1 muffin for breakfast, 1 muffin for afternoon snack and 1 slice of bread for evening snack every day for 4 weeks
Placebo Comparator: whole wheat flour
2 muffins and 1 slice of bread containing whole wheat flour per day
Dietary Supplement: whole wheat flour
1 muffin for breakfast, 1 muffin for afternoon snack and 1 slice of bread for evening snack every day for 4 weeks



Primary Outcome Measures :
  1. fasting serum total cholesterol, triglycerides, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) and C-reactive protein [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. LH (luteinizing hormone, FSH (follicle-stimulating hormone), DHEA-S (Dihydroepiandrosterone sulfate), free testosterone, androstenedione [ Time Frame: 4 weeks ]
  2. complete blood count [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01007344


Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Brian McCrindle, MD The Hospital for Sick Children

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brian McCrindle, Staff Cardiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01007344     History of Changes
Other Study ID Numbers: 1000008297
First Posted: November 4, 2009    Key Record Dates
Last Update Posted: August 27, 2013
Last Verified: August 2013

Keywords provided by Brian McCrindle, The Hospital for Sick Children:
flaxseed
hypercholesterolemia
children

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases