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Flaxseed Compared With Placebo in Patients With Hypercholesterolemia

NCT ID: NCT01007344

Last Updated: 2013-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Familial or Severe Hypercholesterolemia

Keywords

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flaxseed hypercholesterolemia children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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flaxseed

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

Group Type ACTIVE_COMPARATOR

flaxseed

Intervention Type DIETARY_SUPPLEMENT

1 muffin for breakfast, 1 muffin for afternoon snack and 1 slice of bread for evening snack every day for 4 weeks

whole wheat flour

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

Group Type PLACEBO_COMPARATOR

whole wheat flour

Intervention Type DIETARY_SUPPLEMENT

1 muffin for breakfast, 1 muffin for afternoon snack and 1 slice of bread for evening snack every day for 4 weeks

Interventions

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flaxseed

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

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Brian McCrindle

Staff Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brian McCrindle, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 23733031 (View on PubMed)

Other Identifiers

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1000008297

Identifier Type: -

Identifier Source: org_study_id