Clinical trial NCT01911390: Effect of Rice Bran and Cooked Navy Beans on Cholesterol Levels in Healthy Children
Official title: Effect of Rice Bran and Cooked Navy Beans on Cholesterol Levels in Healthy Children Involved in the Healthy Hearts Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemias
Keywords: High cholesterol.
Lead sponsor: Poudre Valley Health System
Sponsor class: OTHER
Collaborators: name: Colorado State University
First posted: 2013-07-30
Enrollment: 41
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: Total Cholesterol
timeFrame: Baseline, 4 weeks
Secondary outcomes:
measure: Palatability
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
Study officials:
affiliation: Colorado State University
name: Elizabeth Ryan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado Health
name: Gary Luckasen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li KJ, Borresen EC, Jenkins-Puccetti N, Luckasen G, Ryan EP. Navy Bean and Rice Bran Intake Alters the Plasma Metabolome of Children at Risk for Cardiovascular Disease. Front Nutr. 2018 Jan 19;4:71. doi: 10.3389/fnut.2017.00071. eCollection 2017.