Hyperlipidemias
Conditions
Keywords
High cholesterol.
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).
Interventions
DIETARY_SUPPLEMENTBean powder
Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders.
DIETARY_SUPPLEMENTRice bran
USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties.
DIETARY_SUPPLEMENTControl arm
No bean or rice bran additive in smoothie or muffin.
DIETARY_SUPPLEMENTBean 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.
Sponsors
Colorado State University
Poudre Valley Health System
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 13 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Cholesterol | Baseline, 4 weeks | The primary outcome variable to be studied is total cholesterol. A full lipid panel report will also provide information on LDL, HDL, triglycerides etc. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Palatability | Baseline, 4 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
The study proposed to randomize approximately 40 subjects to complete 38.
Pre-assignment details
A total of 41 subjects were screened and assented. Of the subjects assessed, 38 (93%) completed the trial with 3 (7%) withdrawn for noncompliance of required food consumption.
Participants by arm
| Arm | Count |
|---|---|
| Control Arm No bean or rice bran additive in smoothie or muffin.
Control arm: No bean or rice bran additive in smoothie or muffin. | 10 |
| Bean Powder 1/4 cup beans (17.5 grams powder)/day in smoothie or muffin.
Bean powder: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders. | 10 |
| Rice Bran 15 grams rice bran/day in smoothie or muffin.
Rice bran: USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties. | 10 |
| Bean Powder and Rice Bran 9 grams bean powder/day and 8 grams rice bran /day in smoothie or muffin.
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. | 11 |
| Total | 41 |
Baseline characteristics
| Characteristic | Control Arm | Bean Powder | Rice Bran | Bean Powder and Rice Bran | Total |
|---|---|---|---|---|---|
| Age, Continuous | 10 years STANDARD_DEVIATION 1 | 10 years STANDARD_DEVIATION 1 | 10 years STANDARD_DEVIATION 1 | 10 years STANDARD_DEVIATION 1 | 10 years STANDARD_DEVIATION 1 |
| Region of Enrollment United States | 9 participants | 10 participants | 9 participants | 10 participants | 38 participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 6 Participants | 5 Participants | 20 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 4 Participants | 6 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 9 | 0 / 10 | 0 / 9 | 0 / 10 |
| serious Total, serious adverse events | 0 / 9 | 0 / 10 | 0 / 9 | 0 / 10 |
Outcome results
Primary
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.
Time frame: Baseline, 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Arm | Total Cholesterol | Baseline Tchol Average | 166 mg/dL | Standard Deviation 13 |
| Control Arm | Total Cholesterol | 4 week post Tchol Average | 165 mg/dL | Standard Deviation 20 |
| Bean Powder | Total Cholesterol | 4 week post Tchol Average | 172 mg/dL | Standard Deviation 33 |
| Bean Powder | Total Cholesterol | Baseline Tchol Average | 178 mg/dL | Standard Deviation 30 |
| Rice Bran | Total Cholesterol | Baseline Tchol Average | 167 mg/dL | Standard Deviation 16 |
| Rice Bran | Total Cholesterol | 4 week post Tchol Average | 171 mg/dL | Standard Deviation 18 |
| Bean Powder and Rice Bran | Total Cholesterol | Baseline Tchol Average | 169 mg/dL | Standard Deviation 26 |
| Bean Powder and Rice Bran | Total Cholesterol | 4 week post Tchol Average | 168 mg/dL | Standard Deviation 22 |
Secondary
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.
Time frame: Baseline, 4 weeks
Population: The criteria used to quantify GI discomforts or issues included participants who responded 'yes' to any GI discomfort and rated the discomfort level ≥3 out of a 5-point scale.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Arm | Palatability | 3 Participants |
| Bean Powder | Palatability | 1 Participants |
| Rice Bran | Palatability | 3 Participants |
| Bean Powder and Rice Bran | Palatability | 1 Participants |