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.

Study Overview

• Status: Completed
• Conditions: Familial or Severe Hypercholesterolemia
• Intervention / Treatment: Dietary supplement: flaxseed; Dietary supplement: whole wheat flour

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
• Enrollment (Actual): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Brian McCrindle, MD, The Hospital for Sick Children

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: November 3, 2009
• First Submitted That Met QC Criteria: November 3, 2009
• First Posted (Estimate): November 4, 2009

Study Record Updates

• Last Update Posted (Estimate): August 27, 2013
• Last Update Submitted That Met QC Criteria: August 25, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: children; flaxseed; hypercholesterolemia
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: 1000008297