1. Copyright restrictions may apply JAMA Pediatrics Journal Club Slides: Flaxseed in Pediatric Hyperlipidemia 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. Published online June 3, 2013. doi:10.1001/jamapediatrics.2013.1442.

2. Copyright restrictions may apply Background –Elevated lipid profiles in youth are risk factors for early development of atherosclerotic lesions and cardiovascular disease. –Pharmacologic interventions are used when lifestyle approaches fail to decrease low-density lipoprotein cholesterol within acceptable ranges. –Dietary flaxseed may be a functional food that contains agents hypothesized to have hypolipidemic activity and/or other properties that may benefit cardiovascular health. Study Objective –To determine the safety and efficacy of dietary flaxseed supplementation in the management of hypercholesterolemia in children. Introduction

3. Copyright restrictions may apply Study Design –Placebo-controlled, randomized clinical trial. –Duration of intervention: 4 weeks. Setting –Specialized dyslipidemia clinic at a tertiary pediatric care center. Patients –32 participants aged 8 to 18 years. –Low-density lipoprotein cholesterol from 135 mg/dL (3.5 mmol/L) to less than 193 mg/dL (5.0 mmol/L). Methods

4. Copyright restrictions may apply Patients –The intervention group ate 2 muffins and 1 slice of bread daily containing ground flaxseed (30 g flaxseed total). –The control group ate muffins and bread substituted with whole-wheat flour. Nutritional Content per Serving of Muffins and Breads Used in the Study Methods

5. Copyright restrictions may apply Methods Outcomes –Primary: Attributable change in fasting lipid profile levels of high-density lipoprotein cholesterol and triglycerides. –Secondary: Attributable change in fasting total cholesterol, low-density lipoprotein cholesterol, body mass index z score, and total caloric intake. Limitations –Flaxseed may lose nutritional value and thus effectiveness when ground for the consumption of muffins and bread by pediatric patients. –Increases in body mass index and daily caloric intake were noted in both study groups during the trial. –Compliance assessments were based on self-report from patient- completed intake logs and not through a direct biological measure. –Small sample size (n = 32) and short duration of intervention (4 weeks).

6. Copyright restrictions may apply Results Comparison of Baseline Characteristics a

7. Copyright restrictions may apply Results Change in Outcomes

8. Copyright restrictions may apply Comment Dietary flaxseed supplementation was associated with no attributable benefit regarding lipid levels. Dietary flaxseed supplementation, while safe, was associated with adverse changes in the lipid profile of children with hypercholesterolemia: –Significant decrease noted in high-density lipoprotein cholesterol level. –Significant increase in triglyceride levels. The use of flaxseed supplementation in children with hypercholesterolemia may not be a viable option for lipid management.

9. Copyright restrictions may apply Comment Nonpharmacologic management of hypercholesterolemia in children is challenging, with few available options. Flaxseed has been proposed as a possible alternative therapy for treating dyslipidemia. The predominant mechanism by which flaxseed influences lipid profiles remains unknown. Flaxseed supplementation remains an unverified strategy for the clinical management of cardiovascular risk factors in youths with hyperlipidemia and may adversely affect the lipid profile.

10. Copyright restrictions may apply If you have questions, please contact the corresponding author: –Brian W. McCrindle, MD, MPH, The Hospital for Sick Children, 555 University Ave, Toronto, ON M5G 1X8, Canada (brian.mccrindle@sickkids.ca). Funding/Support This study was supported by a research grant from the Labatt Family Innovation Fund. Conflict of Interest Disclosures None reported. Contact Information