Overview

This trial is active, not recruiting.

Condition hyperlipidemia.
Treatments bean powder, rice bran, control arm, bean powder and rice bran
Sponsor Poudre Valley Health System
Collaborator Colorado State University
Start date July 2013
End date September 2016
Trial size 40 participants
Trial identifier NCT01911390, Version 06/18/2013

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
No bean or rice bran additive in smoothie or muffin.
control arm Placebo Comparator
No bean or rice bran additive in smoothie or muffin.
(Active Comparator)
1/4 cup beans (17.5 grams powder)/day in smoothie or muffin.
bean powder
Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders.
(Active Comparator)
15 grams rice bran/day in smoothie or muffin.
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)
9 grams bean powder/day and 8 grams rice bran /day in smoothie or muffin.
bean powder and rice bran Bean Powder & 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.

Primary Outcomes

Measure
Total cholesterol
time frame: 4 weeks

Secondary Outcomes

Measure
Palatability and acceptability.
time frame: 4 weeks

Eligibility Criteria

Male or female participants from 8 years up to 13 years old.

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

Additional Information

Official title Effect of Rice Bran and Cooked Navy Beans on Cholesterol Levels in Healthy Children Involved in the Healthy Hearts Program
Principal investigator Elizabeth Ryan, PhD
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).
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Poudre Valley Health System.