JAMA Pediatrics Journal Club Slides: Flaxseed in Pediatric Hyperlipidemia

1. 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. Introduction • 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.

3. Methods • 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).

4. Methods • 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

5. 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. Results Comparison of Baseline Characteristicsa

7. Results Change in Outcomes

8. 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. 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. Contact Information • 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.