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
  Purpose

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 Intervention Phase
Familial or Severe Hypercholesterolemia
Dietary Supplement: flaxseed
Dietary Supplement: whole wheat flour
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A 4-week Study in Children and Adolescents With Familial or Severe Hypercholesterolemia Comparing Flaxseed Therapy to Placebo

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: October 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by The Hospital for Sick Children

Additional 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
Study First Received: November 3, 2009
Last Updated: August 25, 2013
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on August 01, 2014