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| Name | Class |
|---|---|
| Colorado State University | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | Placebo Comparator | No bean or rice bran additive in smoothie or muffin. |
|
| Bean powder | Active Comparator | 1/4 cup beans (17.5 grams powder)/day in smoothie or muffin. |
|
| Rice bran | Active Comparator | 15 grams rice bran/day in smoothie or muffin. |
|
| Bean powder and rice bran | Active Comparator | 9 grams bean powder/day and 8 grams rice bran /day in smoothie or muffin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bean powder | Dietary Supplement | Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Ryan, PhD | Colorado State University | Principal Investigator |
| Gary Luckasen, MD | University of Colorado Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado State University | Fort Collins | Colorado | 80523 | United States | ||
| Medical Center of the Rockies |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29404331 | Derived | 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. |
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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.
The study proposed to randomize approximately 40 subjects to complete 38.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Arm | No bean or rice bran additive in smoothie or muffin. Control arm: No bean or rice bran additive in smoothie or muffin. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Children aged 8-13 years old at risk for CVD due to abnormal lipids were recruited. Elevated cholesterol levels were defined as total cholesterol ≥180mg/dL and HDL <60mg/dL; LDL ≥100mg/dL and HDL <60mg/dL; or non-HDL >100mg/dL and HDL <60mg/dL.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Arm | No bean or rice bran additive in smoothie or muffin. Control arm: No bean or rice bran additive in smoothie or muffin. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | mg/dL | Baseline, 4 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Arm | No bean or rice bran additive in smoothie or muffin. Control arm: No bean or rice bran additive in smoothie or muffin. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Elizabeth Ryan | Department of Environmental and Radiological Health Sciences | 970-491-1536 | E.P.Ryan@colostate.du |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Rice bran | Dietary Supplement | USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties. |
|
| Control arm | Dietary Supplement | No bean or rice bran additive in smoothie or muffin. |
|
|
| Bean powder and rice bran | Dietary Supplement | 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. |
|
|
| Loveland |
| Colorado |
| 80538 |
| United States |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. |
| OG003 | 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. |
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline, 4 weeks |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | 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. | 0 | 10 | 0 | 10 |
| EG002 | 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. | 0 | 9 | 0 | 9 |
| EG003 | 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. | 0 | 10 | 0 | 10 |
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