NCT01911390

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Poudre Valley Health System · Academic / Other
• Sex: All
• Age: 8 Years – 13 Years
• Healthy volunteers: Accepted

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).

Conditions

• Hyperlipidemias

Interventions

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

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-10-01
• Completion: 2016-11-01
• First posted: 2013-07-30
• Last updated: 2017-05-15
• Results posted: 2017-04-05

Locations

2 sites across 1 country: United States