Effect of Rice Bran and Cooked Navy Beans on Cholesterol Levels in Healthy Children
Condition: Hyperlipidemias
MeSH terms: Hyperlipidemias
Study type: Interventional

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).
    

Intervention name(s): Bean powder; Rice bran; Control arm; Bean powder and rice bran
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; No bean or rice bran additive in smoothie or muffin.; 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 intervention name(s): Placebo Comparator; Bean Powder & Rice Bran
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: High cholesterol.