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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Hyperlipidemias

Intervention / Treatment
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* Dietary Supplement: Bean powder
* Dietary Supplement: Rice bran
* Dietary Supplement: Control arm
* Dietary Supplement: Bean powder and rice bran


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High cholesterol.