Colorectal Cancer Control and PreventionBENEFITNCT01929122
Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial
A study testing Cooked Navy Bean Powder Meals and Snacks and Rice Bran Meals and Snacks in people with Colorectal Cancer Control and Prevention, run by Colorado State University at 2 sites in United States.
Trial summary
The purpose of this study is to explore the effects of cooked navy bean powder or rice bran consumption on the stool microbiome and metabolome of colorectal cancer survivors and healthy adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Control and Prevention
- What is being tested?
- Cooked Navy Bean Powder Meals and Snacks and Rice Bran Meals and Snacks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2010to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age.
- Be a Colorectal Cancer Survivor that is a minimum of 4 months post chemotherapy/radiation treatment. OR be a healthy adult with no prior history of treatment for cancer.
- BMI between 25-35
- no previous or concurrent malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer and other cancer for which the patient has been disease free for five years.
- Ability to complete questionnaire(s) and dietary food logs
- Willingness to consume meals/snacks provided for 28 consecutive days
- Drink less than or equal to one alcoholic drink/day
Who cannot join
- History of food allergies and/or major dietary restrictions
- Pregnant or lactating or planning to become pregnant
- Self identified as a smoker
- Taking prescribed medication to control their lipids
- Taking Bean-O, other anti-flatulence medications or prolonged antibiotic use (one month)
- Have a history of gallstones.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Colorado State University
Fort Collins, Colorado, 80523
Poudre Valley Hospital Oncology Research
Fort Collins, Colorado, 80528
About this study
Official title: BENEFIT: Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial
The purpose of this study is to explore the effects of cooked navy bean powder or rice bran consumption on the stool microbiome and metabolome of colorectal cancer survivors and healthy adults.
Read the detailed description
Objectives:
- To learn about how increased cooked navy bean powders or rice bran dietary intake affect the stool microbiota of colorectal cancer survivors and healthy adults.
- To determine whether cooked navy bean powders or rice bran consumption modulate microbial metabolism.
- To observe dietary changes in the blood, urine and stool metabolite profiles and inflammatory cytokines.
- Conditions
- Colorectal Cancer Control and Prevention
- Being tested
- Placebo-Control Meals and Snacks, Cooked Navy Bean Powder Meals and Snacks, Rice Bran Meals and Snacks
- Keywords
- Prevention & control, Diet, Functional food, Nutrition Assessment, Oryza sativa, Rice Bran, Phaseolus vulgaris L., Legumes, Microbiome, Metabolomics, Prebiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo-Control Meals and SnacksDietary supplement
Also called Whole food dietary intervention
Cooked Navy Bean Powder Meals and SnacksDietary supplement
Also called Whole food dietary intervention
Rice Bran Meals and SnacksDietary supplement
Also called Whole food dietary intervention
| Study group | Role | What they receive |
|---|---|---|
| Placebo-Control | Placebo comparator | Randomized participants consume 1 meal and 1 snack per day that does not include either rice bran or navy bean powder for 28 days. Receives: Dietary Supplement: Placebo-Control Meals and Snacks |
| Cooked Navy Bean Powder | Experimental | Randomized participants consume 1 meal and 1 snack per day containing cooked navy bean powder (35 g/day) for 28 days. Receives: Dietary Supplement: Cooked Navy Bean Powder Meals and Snacks |
| Rice Bran | Experimental | Randomized participants consume 1 meal and 1 snack per day containing rice bran (30 g/day) for 28 days. Receives: Dietary Supplement: Rice Bran Meals and Snacks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool Microbiome Composition and Metabolome
Measured: 5 years
Secondary outcomes (1)
Navy Bean or Rice Bran metabolites in stool, urine and blood.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study startAug 2010
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer Control and PreventionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Poudre Valley Health System
- Responsible party
- Principal investigator, Elizabeth P Ryan, Colorado State University
- Investigators
- Elizabeth P Ryan, PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929122
- Sponsor's protocol ID
- 10-1038
- Other IDs
- 1R21CA161472-01A1
- Acronym
- BENEFIT
- Status last verified
- Jul 2017
- First submitted
- 22 Aug 2013
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Borresen EC, Gundlach KA, Wdowik M, Rao S, Brown RJ, Ryan EP. Feasibility of Increased Navy Bean Powder Consumption for Primary and Secondary Colorectal Cancer Prevention. Curr Nutr Food Sci. 2014 May;10(2):112-119. doi: 10.2174/1573401310666140306005934.
PubMed 25009453Borresen EC, Brown DG, Harbison G, Taylor L, Fairbanks A, O'Malia J, Bazan M, Rao S, Bailey SM, Wdowik M, Weir TL, Brown RJ, Ryan EP. A Randomized Controlled Trial to Increase Navy Bean or Rice Bran Consumption in Colorectal Cancer Survivors. Nutr Cancer. 2016 Nov-Dec;68(8):1269-1280. doi: 10.1080/01635581.2016.1224370. Epub 2016 Sep 30.
PubMed 27689688Sheflin AM, Borresen EC, Kirkwood JS, Boot CM, Whitney AK, Lu S, Brown RJ, Broeckling CD, Ryan EP, Weir TL. Dietary supplementation with rice bran or navy bean alters gut bacterial metabolism in colorectal cancer survivors. Mol Nutr Food Res. 2017 Jan;61(1):10.1002/mnfr.201500905. doi: 10.1002/mnfr.201500905. Epub 2016 Sep 12.
PubMed 27461523
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BENEFIT: Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial
- ClinicalTrials.gov ID
- NCT01929122
- Acronym / sponsor ID
- BENEFIT / 10-1038
- Conditions
- Colorectal Cancer Control and Prevention
- Keywords
- Prevention & control, Diet, Functional food, Nutrition Assessment, Oryza sativa, Rice Bran, Phaseolus vulgaris L., Legumes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Poudre Valley Health System
- Study start
- Aug 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 27 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore the effects of cooked navy bean powder or rice bran consumption on the stool microbiome and metabolome of colorectal cancer survivors and healthy adults.
Detailed description
Objectives:
- To learn about how increased cooked navy bean powders or rice bran dietary intake affect the stool microbiota of colorectal cancer survivors and healthy adults.
- To determine whether cooked navy bean powders or rice bran consumption modulate microbial metabolism.
- To observe dietary changes in the blood, urine and stool metabolite profiles and inflammatory cytokines.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo-Control | Placebo comparator | Dietary Supplement: Placebo-Control Meals and SnacksRandomized participants consume 1 meal and 1 snack per day that does not include either rice bran or navy bean powder for 28 days. |
| Cooked Navy Bean Powder | Experimental | Dietary Supplement: Cooked Navy Bean Powder Meals and SnacksRandomized participants consume 1 meal and 1 snack per day containing cooked navy bean powder (35 g/day) for 28 days. |
| Rice Bran | Experimental | Dietary Supplement: Rice Bran Meals and SnacksRandomized participants consume 1 meal and 1 snack per day containing rice bran (30 g/day) for 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 18 years of age.
- Be a Colorectal Cancer Survivor that is a minimum of 4 months post chemotherapy/radiation treatment. OR be a healthy adult with no prior history of treatment for cancer.
- BMI between 25-35
- no previous or concurrent malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer and other cancer for which the patient has been disease free for five years.
- Ability to complete questionnaire(s) and dietary food logs
Key exclusion criteria (6 listed)
- History of food allergies and/or major dietary restrictions
- Pregnant or lactating or planning to become pregnant
- Self identified as a smoker
- Taking prescribed medication to control their lipids
- Taking Bean-O, other anti-flatulence medications or prolonged antibiotic use (one month)
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 |
|---|---|---|
| Placebo-Control Meals and SnacksAlso: Whole food dietary intervention | Dietary supplement | Placebo-Control |
| Cooked Navy Bean Powder Meals and SnacksAlso: Whole food dietary intervention | Dietary supplement | Cooked Navy Bean Powder |
| Rice Bran Meals and SnacksAlso: Whole food dietary intervention | Dietary supplement | Rice Bran |
Primary outcome
Stool Microbiome Composition and Metabolome
Time frame: 5 years
1 secondary outcome
Navy Bean or Rice Bran metabolites in stool, urine and blood.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Results publication: PubMed 25009453Borresen EC, Gundlach KA, Wdowik M, Rao S, Brown RJ, Ryan EP. Feasibility of Increased Navy Bean Powder Consumption for Primary and Secondary Colorectal Cancer Prevention. Curr Nutr Food Sci. 2014 May;10(2):112-119. doi: 10.2174/1573401310666140306005934.
- Results publication: PubMed 27689688Borresen EC, Brown DG, Harbison G, Taylor L, Fairbanks A, O'Malia J, Bazan M, Rao S, Bailey SM, Wdowik M, Weir TL, Brown RJ, Ryan EP. A Randomized Controlled Trial to Increase Navy Bean or Rice Bran Consumption in Colorectal Cancer Survivors. Nutr Cancer. 2016 Nov-Dec;68(8):1269-1280. doi: 10.1080/01635581.2016.1224370. Epub 2016 Sep 30.
- Results publication: PubMed 27461523Sheflin AM, Borresen EC, Kirkwood JS, Boot CM, Whitney AK, Lu S, Brown RJ, Broeckling CD, Ryan EP, Weir TL. Dietary supplementation with rice bran or navy bean alters gut bacterial metabolism in colorectal cancer survivors. Mol Nutr Food Res. 2017 Jan;61(1):10.1002/mnfr.201500905. doi: 10.1002/mnfr.201500905. Epub 2016 Sep 12.
- Related InformationLink provided by the sponsor.
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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 P Ryan, PhD principal investigator
Colorado State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooked Navy Bean Powder Meals and Snacks and Rice Bran Meals and Snacks in people with Colorectal Cancer Control and Prevention, run by Colorado State University 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 7 inclusion and 6 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 21 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Stool Microbiome Composition and Metabolome (time frame: 5 years). 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 NCT01929122, which also lists 3 linked publications.
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 21 Jul 2017.