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Flaxseed Compared With Placebo in Patients With Hypercholesterolemia

Primary Purpose

Familial or Severe Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
flaxseed
whole wheat flour
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Familial or Severe Hypercholesterolemia focused on measuring flaxseed, hypercholesterolemia, children

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

flaxseed

whole wheat flour

Arm Description

2 muffins and 1 slice of bread for a total of 30g flaxseed per day

2 muffins and 1 slice of bread containing whole wheat flour per day

Outcomes

Primary Outcome Measures

fasting serum total cholesterol, triglycerides, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) and C-reactive protein

Secondary Outcome Measures

LH (luteinizing hormone, FSH (follicle-stimulating hormone), DHEA-S (Dihydroepiandrosterone sulfate), free testosterone, androstenedione
complete blood count

Full Information

First Posted
November 3, 2009
Last Updated
August 25, 2013
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT01007344
Brief Title
Flaxseed Compared With Placebo in Patients With Hypercholesterolemia
Official Title
A 4-week Study in Children and Adolescents With Familial or Severe Hypercholesterolemia Comparing Flaxseed Therapy to Placebo
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Familial or Severe Hypercholesterolemia
Keywords
flaxseed, hypercholesterolemia, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
flaxseed
Arm Type
Active Comparator
Arm Description
2 muffins and 1 slice of bread for a total of 30g flaxseed per day
Arm Title
whole wheat flour
Arm Type
Placebo Comparator
Arm Description
2 muffins and 1 slice of bread containing whole wheat flour per day
Intervention Type
Dietary Supplement
Intervention Name(s)
flaxseed
Intervention Description
1 muffin for breakfast, 1 muffin for afternoon snack and 1 slice of bread for evening snack every day for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
whole wheat flour
Intervention Description
1 muffin for breakfast, 1 muffin for afternoon snack and 1 slice of bread for evening snack every day for 4 weeks
Primary Outcome Measure Information:
Title
fasting serum total cholesterol, triglycerides, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) and C-reactive protein
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
LH (luteinizing hormone, FSH (follicle-stimulating hormone), DHEA-S (Dihydroepiandrosterone sulfate), free testosterone, androstenedione
Time Frame
4 weeks
Title
complete blood count
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian McCrindle, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23733031
Citation
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.
Results Reference
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Flaxseed Compared With Placebo in Patients With Hypercholesterolemia

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