search
Back to results

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

Primary Purpose

Hyperlipidemias

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bean powder
Rice bran
Control arm
Bean powder and rice bran
Sponsored by
Poudre Valley Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemias focused on measuring High cholesterol.

Eligibility Criteria

8 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Colorado State University
  • Medical Center of the Rockies

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Control Arm

Bean powder

Rice bran

Bean powder and rice bran

Arm Description

No bean or rice bran additive in smoothie or muffin.

1/4 cup beans (17.5 grams powder)/day in smoothie or muffin.

15 grams rice bran/day in smoothie or muffin.

9 grams bean powder/day and 8 grams rice bran /day in smoothie or muffin.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 25, 2013
Last Updated
May 12, 2017
Sponsor
Poudre Valley Health System
Collaborators
Colorado State University
search

1. Study Identification

Unique Protocol Identification Number
NCT01911390
Brief Title
Effect of Rice Bran and Cooked Navy Beans on Cholesterol Levels in Healthy Children
Official Title
Effect of Rice Bran and Cooked Navy Beans on Cholesterol Levels in Healthy Children Involved in the Healthy Hearts Program
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poudre Valley Health System
Collaborators
Colorado State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemias
Keywords
High cholesterol.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
Placebo Comparator
Arm Description
No bean or rice bran additive in smoothie or muffin.
Arm Title
Bean powder
Arm Type
Active Comparator
Arm Description
1/4 cup beans (17.5 grams powder)/day in smoothie or muffin.
Arm Title
Rice bran
Arm Type
Active Comparator
Arm Description
15 grams rice bran/day in smoothie or muffin.
Arm Title
Bean powder and rice bran
Arm Type
Active Comparator
Arm Description
9 grams bean powder/day and 8 grams rice bran /day in smoothie or muffin.
Intervention Type
Dietary Supplement
Intervention Name(s)
Bean powder
Intervention Description
Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders.
Intervention Type
Dietary Supplement
Intervention Name(s)
Rice bran
Intervention Description
USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties.
Intervention Type
Dietary Supplement
Intervention Name(s)
Control arm
Other Intervention Name(s)
Placebo Comparator
Intervention Description
No bean or rice bran additive in smoothie or muffin.
Intervention Type
Dietary Supplement
Intervention Name(s)
Bean powder and rice bran
Other Intervention Name(s)
Bean Powder & Rice Bran
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total Cholesterol
Description
The primary outcome variable to be studied is total cholesterol. A full lipid panel report will also provide information on LDL, HDL, triglycerides etc.
Time Frame
Baseline, 4 weeks
Secondary Outcome Measure Information:
Title
Palatability
Description
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.
Time Frame
Baseline, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Ryan, PhD
Organizational Affiliation
Colorado State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gary Luckasen, MD
Organizational Affiliation
University of Colorado Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Colorado State University
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80523
Country
United States
Facility Name
Medical Center of the Rockies
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29404331
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs