Trial Outcomes & Findings for Effect of Rice Bran and Cooked Navy Beans on Cholesterol Levels in Healthy Children (NCT NCT01911390)
NCT ID: NCT01911390
Last Updated: 2017-05-15
Results Overview
The primary outcome variable to be studied is total cholesterol. A full lipid panel report will also provide information on LDL, HDL, triglycerides etc.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
Baseline, 4 weeks
Results posted on
2017-05-15
Participant Flow
The study proposed to randomize approximately 40 subjects to complete 38.
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 Of the subjects assessed, 38 (93%) completed the trial with 3 (7%) withdrawn for noncompliance of required food consumption.
Participant milestones
| Measure |
Control Arm
No bean or rice bran additive in smoothie or muffin.
Control arm: No bean or rice bran additive in smoothie or muffin.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
11
|
|
Overall Study
COMPLETED
|
9
|
10
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Rice Bran and Cooked Navy Beans on Cholesterol Levels in Healthy Children
Baseline characteristics by cohort
| Measure |
Control Arm
n=10 Participants
No bean or rice bran additive in smoothie or muffin.
Control arm: No bean or rice bran additive in smoothie or muffin.
|
Bean Powder
n=10 Participants
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.
|
Rice Bran
n=10 Participants
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.
|
Bean Powder and Rice Bran
n=11 Participants
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.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
10 years
STANDARD_DEVIATION 1 • n=5 Participants
|
10 years
STANDARD_DEVIATION 1 • n=7 Participants
|
10 years
STANDARD_DEVIATION 1 • n=5 Participants
|
10 years
STANDARD_DEVIATION 1 • n=4 Participants
|
10 years
STANDARD_DEVIATION 1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
9 participants
n=5 Participants
|
10 participants
n=4 Participants
|
38 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 weeksThe primary outcome variable to be studied is total cholesterol. A full lipid panel report will also provide information on LDL, HDL, triglycerides etc.
Outcome measures
| Measure |
Control Arm
n=9 Participants
No bean or rice bran additive in smoothie or muffin.
Control arm: No bean or rice bran additive in smoothie or muffin.
|
Bean Powder
n=10 Participants
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.
|
Rice Bran
n=9 Participants
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.
|
Bean Powder and Rice Bran
n=10 Participants
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.
|
|---|---|---|---|---|
|
Total Cholesterol
Baseline Tchol Average
|
166 mg/dL
Standard Deviation 13
|
178 mg/dL
Standard Deviation 30
|
167 mg/dL
Standard Deviation 16
|
169 mg/dL
Standard Deviation 26
|
|
Total Cholesterol
4 week post Tchol Average
|
165 mg/dL
Standard Deviation 20
|
172 mg/dL
Standard Deviation 33
|
171 mg/dL
Standard Deviation 18
|
168 mg/dL
Standard Deviation 22
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Control Arm
n=9 Participants
No bean or rice bran additive in smoothie or muffin.
Control arm: No bean or rice bran additive in smoothie or muffin.
|
Bean Powder
n=10 Participants
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.
|
Rice Bran
n=9 Participants
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.
|
Bean Powder and Rice Bran
n=10 Participants
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.
|
|---|---|---|---|---|
|
Palatability
|
3 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
Adverse Events
Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bean Powder
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Rice Bran
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bean Powder and Rice Bran
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Elizabeth Ryan
Department of Environmental and Radiological Health Sciences
Phone: 970-491-1536
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place