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Flaxseed Compared With Placebo in Patients With Hypercholesterolemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brian McCrindle, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01007344
First received: November 3, 2009
Last updated: August 25, 2013
Last verified: August 2013

November 3, 2009
August 25, 2013
October 2009
December 2010   (final data collection date for primary outcome measure)
fasting serum total cholesterol, triglycerides, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) and C-reactive protein [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01007344 on ClinicalTrials.gov Archive Site
  • LH (luteinizing hormone, FSH (follicle-stimulating hormone), DHEA-S (Dihydroepiandrosterone sulfate), free testosterone, androstenedione [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • complete blood count [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Familial or Severe Hypercholesterolemia
  • 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
  • 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
  • Active Comparator: flaxseed
    2 muffins and 1 slice of bread for a total of 30g flaxseed per day
    Intervention: Dietary Supplement: flaxseed
  • Placebo Comparator: whole wheat flour
    2 muffins and 1 slice of bread containing whole wheat flour per day
    Intervention: Dietary Supplement: whole wheat flour
Wong H, Chahal N, Manlhiot C, Niedra E, McCrindle BW. Flaxseed in pediatric hyperlipidemia: a placebo-controlled, blinded, randomized clinical trial of dietary flaxseed supplementation for children and adolescents with hypercholesterolemia. JAMA Pediatr. 2013 Aug 1;167(8):708-13. doi: 10.1001/jamapediatrics.2013.1442.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
8 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01007344
1000008297
No
Brian McCrindle, The Hospital for Sick Children
The Hospital for Sick Children
Not Provided
Principal Investigator: Brian McCrindle, MD The Hospital for Sick Children
The Hospital for Sick Children
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP