Glycemic Response of Bean-and-rice Meals in Type 2 Diabetes Mellitus
Tracking Information | |||||
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First Received Date ICMJE | October 27, 2010 | ||||
Last Updated Date | November 12, 2010 | ||||
Start Date ICMJE | November 2009 | ||||
Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Net blood glucose changes over time [ Time Frame: fasting baseline glucose at time 0, then 30, 60, 90, 120, 150, and 180 minutes postprandial ] [ Designated as safety issue: No ] Capillary blood samples were collected via fingerstick using Safe-T-Fill® Lithium Heparin Mini Capillary Collection 125µl tubes (RAM Scientific, Yonkers, NY). Whole blood samples were analyzed for glucose content using the Yellow Springs Instrument Stat Plus Analyzer (YSI Life Sciences, Yellow Springs, OH) immediately after blood collection. |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01241253 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Glycemic Response of Bean-and-rice Meals in Type 2 Diabetes Mellitus | ||||
Official Title ICMJE | Glycemic Response of Bean-and-rice Meals in Persons With Type 2 Diabetes Mellitus | ||||
Brief Summary | The study uses a randomized, placebo-controlled experimental design consisting of 4 different test treatments matched on carbohydrate (CHO) content. The three beans are similar in their CHO content amount for ½ cup at ~20 grams CHO. Each of the bean varieties will be served in a ~½ cup serving size with ~ ½ cup of plain steamed white rice (30 grams CHO) for a total of 50 grams of CHO per meal for each of the three test treatments. The 4th placebo or control treatment consists of ~ 7/8 cup of rice alone, an amount consistent with the CHO content of the test meals. Most diabetic meal plans recommend no more than 45-60 grams of CHO per meal. Fifty grams of CHO is a standard amount for glycemic response testing in general. The investigators hypotheses were:
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Detailed Description | The 4 test treatments will be administered randomly on a different morning, at least one week apart. Participants will be required to consume the entire test treatment meal in 7 minutes while being observed. All test foods will be purchased from local markets. Capillary blood samples will be collected (~50µl) at time 0 (fasting) and at 30, 60, 90, 120 and 180 minutes post-treatment (timing of the post-treatment blood draws started at time 0 [post-treatment], which is when the participant finishes consuming the treatment meal). Venous blood draws for insulin assessment will also be acquired at fasting and then every hour for the three hour study period. Anthropometric measures such as weight, height and waist circumference will be collected at screening and at the start of each test day. Thirteen hours before testing, participants will eat a control meal to reduce variation in glycemic responses on test days due to varying dietary intakes. This control meal will be selected by each participant before the start of the study. They will be provided a gift card to the chain restaurant to use to purchase their own meal. Since subjects serve as their own controls, the meals must be identical before each test draw. Participants will complete 24 hour recall food records the morning of each test day to provide information related to dietary protocol compliance. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
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Condition ICMJE |
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Intervention ICMJE | Other: Whole cooked beans with rice meals
Three types of bean-and-rice meals all equal to 50 grams available CHO. Control treatment was 50 grams available CHO in the form of white rice alone.
Other Name: Bush Brothers & Company brand canned beans |
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Study Arm (s) | No Intervention: Cross-over study
beans and rice in a 50 gram carbohydrate dose
Intervention: Other: Whole cooked beans with rice meals |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 17 | ||||
Completion Date | April 2010 | ||||
Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 35 Years to 70 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01241253 | ||||
Other Study ID Numbers ICMJE | NTS0020 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Donna M Winham, Arizona State University | ||||
Study Sponsor ICMJE | Arizona State University | ||||
Collaborators ICMJE | United States Dry Bean Council | ||||
Investigators ICMJE |
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Information Provided By | Arizona State University | ||||
Verification Date | November 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |