HyperlipidemiasNCT01911390
Effect of Rice Bran and Cooked Navy Beans on Cholesterol Levels in Healthy Children
A study testing Bean powder, Rice bran and Bean powder and rice bran in people with Hyperlipidemias, run by Poudre Valley Health System at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemias
- What is being tested?
- Bean powder, Rice bran and Bean powder and rice bran
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2013to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- History of food allergies and/or major dietary restrictions
- Taking prescribed medication
- Ongoing medical illness
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Colorado State University
Fort Collins, Colorado, 80523
Medical Center of the Rockies
Loveland, Colorado, 80538
About this study
Official title: Effect of Rice Bran and Cooked Navy Beans on Cholesterol Levels in Healthy Children Involved in the Healthy Hearts Program
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.
Read the 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).
- Conditions
- Hyperlipidemias
- Being tested
- Bean powder, Rice bran, Control arm, Bean powder and rice bran
- Keywords
- High cholesterol.
- Medical subject headings
- Hyperlipidemias, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bean powderDietary supplement
Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders.
Rice branDietary supplement
USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties.
Control armDietary supplement
Also called Placebo Comparator
No bean or rice bran additive in smoothie or muffin.
Bean powder and rice branDietary supplement
Also called Bean Powder & 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.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Placebo comparator | No bean or rice bran additive in smoothie or muffin. Receives: Dietary Supplement: Control arm |
| Bean powder | Active comparator | 1/4 cup beans (17.5 grams powder)/day in smoothie or muffin. Receives: Dietary Supplement: Bean powder |
| Rice bran | Active comparator | 15 grams rice bran/day in smoothie or muffin. Receives: Dietary Supplement: Rice bran |
| Bean powder and rice bran | Active comparator | 9 grams bean powder/day and 8 grams rice bran /day in smoothie or muffin. Receives: Dietary Supplement: Bean powder and rice bran |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks
Secondary outcomes (1)
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.
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poudre Valley Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado State University
- Responsible party
- Principal investigator, Gary J. Luckasen, MD, Poudre Valley Health System
- Investigators
- Elizabeth Ryan, PhD, Principal investigator, Colorado State UniversityGary Luckasen, MD, Principal investigator, University of Colorado Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911390
- Sponsor's protocol ID
- Version 06/18/2013
- Status last verified
- May 2017
- First submitted
- 25 Jul 2013
- Last updated
- 15 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29404331
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rice Bran and Cooked Navy Beans on Cholesterol Levels in Healthy Children Involved in the Healthy Hearts Program
- ClinicalTrials.gov ID
- NCT01911390
- Acronym / sponsor ID
- Version 06/18/2013
- Conditions
- Hyperlipidemias
- Keywords
- High cholesterol.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Poudre Valley Health SystemUniversity, hospital or other
- Collaborators
- Colorado State University
- Study start
- Jul 2013 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Posted 5 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Placebo comparator | Dietary Supplement: Control armNo bean or rice bran additive in smoothie or muffin. |
| Bean powder | Active comparator | Dietary Supplement: Bean powder1/4 cup beans (17.5 grams powder)/day in smoothie or muffin. |
| Rice bran | Active comparator | Dietary Supplement: Rice bran15 grams rice bran/day in smoothie or muffin. |
| Bean powder and rice bran | Active comparator | Dietary Supplement: Bean powder and rice bran9 grams bean powder/day and 8 grams rice bran /day in smoothie or muffin. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- History of food allergies and/or major dietary restrictions
- Taking prescribed medication
- Ongoing medical illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bean powderArcher Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders. | Dietary supplement | Bean powder |
| Rice branUSDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties. | Dietary supplement | Rice bran |
| Control armAlso: Placebo ComparatorNo bean or rice bran additive in smoothie or muffin. | Dietary supplement | Control Arm |
| Bean powder and rice branAlso: Bean Powder & Rice BranArcher 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. | Dietary supplement | Bean powder and rice bran |
Primary outcome
Total Cholesterol
Time frame: 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.
1 secondary outcome
Palatability
Time frame: Baseline, 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29404331Li 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.
- Individual participant dataSharing planned: No
Related trials for Hyperlipidemias
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Lipid Metabolism Disorders
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Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
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Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Ryan, PhD principal investigator
Colorado State University
Gary Luckasen, MD principal investigator
University of Colorado Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bean powder, Rice bran and Bean powder and rice bran in people with Hyperlipidemias, run by Poudre Valley Health System at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Cholesterol (time frame: Baseline, 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01911390, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.