N/A
N=41
Effect of Rice Bran and Cooked Navy Beans on Cholesterol Levels in Healthy Children
Hyperlipidemias
Bottom Line
View on ClinicalTrials.gov: NCT01911390 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Total Cholesterol — 166; 178; 167; 169 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bean powder (Dietary_supplement); Rice bran (Dietary_supplement); Control arm (Dietary_supplement); Bean powder and rice bran (Dietary_supplement)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- Poudre Valley Health System
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Cholesterol |
166; 178; 167; 169; 165; 172 | — |
| SECONDARY Palatability |
3; 1; 3; 1 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01911390). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.