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

Hyperlipidemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01911390
• Other study ID #: Version 06/18/2013
• Status: Completed
• Phase: N/A
• First received: July 25, 2013
• Last updated: May 12, 2017
• Start date: July 2013
• Est. completion date: November 2016

Study information

• Verified date: May 2017
• Source: Poudre Valley Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemias

Intervention

Dietary Supplement:
• Bean powder
Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders.
• Rice bran
USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties.
• Control arm
No bean or rice bran additive in smoothie or muffin.
• 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.

Locations

Country	Name	City	State
United States	Colorado State University	Fort Collins	Colorado
United States	Medical Center of the Rockies	Loveland	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Poudre Valley Health System	Colorado State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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