title: A Pilot Randomized Controlled Clinical Trial to Assess Tolerance and Efficacy of Navy Bean and Rice Bran Supplementation for Lowering Cholesterol in Children.
abstract: Background:Navy beans and rice bran demonstrate efficacy to regulate serum cholesterol in hypercholesterolemic adults; however, the cardiovascular disease (CVD) protective properties of these foods in children are unknown and merit investigation.Objective:The objectives were to determine whether cooked navy bean powder (NBP) and/or heat-stabilized rice bran (RB) supplementation is tolerable, improves dietary fiber intake in children, and modulates lipid profiles.Methods:Children aged 8 to 13 years at risk for CVD due to abnormal lipids were recruited. Elevated cholesterol levels were defined as total cholesterol ≥180 mg/dL and high-density lipoprotein (HDL) <60 mg/dL; low-density lipoprotein (LDL) ≥100 mg/dL and HDL <60 mg/dL; or non-HDL >100 mg/dL and HDL <60 mg/dL. Participants completed a pilot 4-week, randomized controlled, 4-arm dietary intervention. They consumed study-provided muffins or a smoothie daily that included 0 g NBP or RB (control), 17.5 g NBP, 15 g RB, or a combination 9 g NBP + 8 g RB. Fasting blood was collected at baseline and week 4. Participants also completed 3-day food logs and gastrointestinal health questionnaires.
  
  
  RESULTS
  Thirty-eight children completed the trial (n = 9 control, n = 10 NBP, n = 9 RB, and n = 10 NBP + RB groups). Only 3 participants withdrew due to noncompliance of required food consumption. Participants in the intervention groups significantly increased intake of NBP and RB at week 4 (p≤.01). The NBP and NBP + RB groups increased total fiber intake from baseline to week 4 (p=.02 and p=<.01, respectively). HDL-cholesterol was higher in NBP-group participants compared to control at week 4 (P= .02).Conclusion:Increasing NBP and/or RB intake is tolerable for children, and our findings suggest higher daily intakes are needed for a longer duration to induce favorable changes across multiple serum lipid parameters.
authors.affiliation: Colorado State University, Fort Collins, CO, USA.
authors.forename: Erica C
authors.initials: EC
authors.lastname: Borresen
authors.affiliation: University of Colorado Health Research-Northern Region, Medical Center of the Rockies, Loveland, CO, USA.
authors.forename: NaNet
authors.initials: N
authors.lastname: Jenkins-Puccetti
authors.affiliation: Colorado State University, Fort Collins, CO, USA.
authors.forename: Katie
authors.initials: K
authors.lastname: Schmitz
authors.affiliation: Colorado State University, Fort Collins, CO, USA.
authors.forename: Dustin G
authors.initials: DG
authors.lastname: Brown
authors.affiliation: University of Colorado Health Research-Northern Region, Medical Center of the Rockies, Loveland, CO, USA.
authors.forename: Austin
authors.initials: A
authors.lastname: Pollack
authors.affiliation: Colorado State University, Fort Collins, CO, USA.
authors.forename: Amanda
authors.initials: A
authors.lastname: Fairbanks
authors.affiliation: Colorado State University, Fort Collins, CO, USA.
authors.forename: Melissa
authors.initials: M
authors.lastname: Wdowik
authors.affiliation: Colorado State University, Fort Collins, CO, USA.
authors.forename: Sangeeta
authors.initials: S
authors.lastname: Rao
authors.affiliation: Colorado State University, Fort Collins, CO, USA.
authors.forename: Tracy L
authors.initials: TL
authors.lastname: Nelson
authors.affiliation: Colorado State University, Fort Collins, CO, USA; University of Colorado Health Research-Northern Region, Medical Center of the Rockies, Loveland, CO, USA.
authors.forename: Gary
authors.initials: G
authors.lastname: Luckasen
authors.affiliation: Colorado State University, Fort Collins, CO, USA.
authors.forename: Elizabeth P
authors.initials: EP
authors.lastname: Ryan
keywords: cardiovascular disease prevention; dietary fiber; hypercholesterolemia; navy beans; rice bran