Effect of Rice Bran and Cooked Navy Beans on Cholesterol Levels in Healthy Children

Effect of Rice Bran and Cooked Navy Beans on Cholesterol Levels in Healthy Children Involved in the Healthy Hearts Program

A multidisciplinary team of clinicians and researchers will conduct a pilot feasibility study to evaluate whether dietary intake of dry bean powder or rice bran or a combination is a helpful dietary recommendation to reduce total cholesterol levels in children with identified, modifiable CVD risk factors, elevated total cholesterol and obesity. Consumption of dry bean powder and rice bran merit additional investigation to study feasibility and acceptability in children and how they influence their lipid levels or obesity.

Study Overview

• Status: Completed
• Conditions: Hyperlipidemias
• Intervention / Treatment: Dietary supplement: Control arm; Dietary supplement: Bean powder; Dietary supplement: Rice bran; Dietary supplement: Bean powder and rice bran

Detailed Description

Children will be screened prior to participation with the expectation of enrolling 40 to randomize equally to either the control arm or one of the three intervention arms. This should assure that at least 10 participants would complete each intervention. The four groups are placebo (no bean powder or rice bran included), 1/4 cup cooked navy bean powder (17.5grams powder)/day, 15 grams rice bran/day, and combination of 9 grams of bean powder/day and 8 grams rice bran/day. Participants will follow this dietary intervention by being provided a study snack, such as a banana nut muffin and strawberry-pineapple smoothie. Participants will consume one snack on a daily basis for a total of four weeks (28 days). The snack options were developed by a professional chef and research dietitian to fit a set of requirements for calorie and macronutrient content based on USDA food guide recommendations. The placebo group will be provided the same snacks without the inclusion of rice bran or bean powder.

Randomization of subjects to the dietary intervention groups will be done during the study enrollment period. Randomization will be based on sex of the subject to include equal numbers of both genders across all 4 groups.

All participants will consume the allocated foods daily for a total of four weeks (28 days) and will not be required to alter the rest of their diets in any other way. They will also complete a 3-day food and activity log each week, starting the week prior to the study intervention (Week 0) and ending the week of their final visit (Week 4).

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Fort Collins, Colorado, United States, 80523
      • Colorado State University
    • Loveland, Colorado, United States, 80538
      • Medical Center of the Rockies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 13 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children between the ages of 8-13 years old who were screened by the Healthy Hearts Club
• Non-fasting total cholesterol greater than or equal to 180 mg/dl
• Non-fasting LDL greater than or equal to 100mg/dl
• Non-fasting HDL less than 60mg/dl
• Willing to consume study provided ingredient (cooked dry bean powder or rice bran or combination) for 28 consecutive days.

Exclusion Criteria:

• History of food allergies and/or major dietary restrictions
• Taking prescribed medication
• Ongoing medical illness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Arm; No bean or rice bran additive in smoothie or muffin.	Dietary supplement: Control arm; No bean or rice bran additive in smoothie or muffin.; Other Names: Placebo Comparator
Active Comparator: Bean powder; 1/4 cup beans (17.5 grams powder)/day in smoothie or muffin.	Dietary supplement: Bean powder; Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders.
Active Comparator: Rice bran; 15 grams rice bran/day in smoothie or muffin.	Dietary supplement: Rice bran; USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties.
Active Comparator: Bean powder and rice bran; 9 grams bean powder/day and 8 grams rice bran /day in smoothie or muffin.	Dietary supplement: Bean powder and rice bran; Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders. USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties.; Other Names: Bean Powder & Rice Bran

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Cholesterol	The primary outcome variable to be studied is total cholesterol. A full lipid panel report will also provide information on LDL, HDL, triglycerides etc.	Baseline, 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Palatability	Other outcomes include palatability and acceptability of study-provided snacks that include cooked navy bean powder, rice bran, or a combination in children. The participants will fill out questionaires describing how the products tasted and how much they consumed.	Baseline, 4 weeks

Collaborators and Investigators

• Sponsor: Poudre Valley Health System
• Collaborators: Colorado State University
• Investigators: Principal Investigator: Elizabeth Ryan, PhD, Colorado State University; Principal Investigator: Gary Luckasen, MD, University of Colorado Health

Publications and helpful links

General Publications

• Li KJ, Borresen EC, Jenkins-Puccetti N, Luckasen G, Ryan EP. Navy Bean and Rice Bran Intake Alters the Plasma Metabolome of Children at Risk for Cardiovascular Disease. Front Nutr. 2018 Jan 19;4:71. doi: 10.3389/fnut.2017.00071. eCollection 2017.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2013
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: July 25, 2013
• First Submitted That Met QC Criteria: July 26, 2013
• First Posted (Estimate): July 30, 2013

Study Record Updates

• Last Update Posted (Actual): May 15, 2017
• Last Update Submitted That Met QC Criteria: May 12, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: High cholesterol.
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias
• Other Study ID Numbers: Version 06/18/2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO