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Glycemic Response of Bean-and-rice Meals in Type 2 Diabetes Mellitus

Primary Purpose

Blood Glucose, Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Whole cooked beans with rice meals
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Blood Glucose focused on measuring legumes, glycemic response, glucose, type 2 diabetes mellitus

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Eligible subjects will be between the ages of 35 and 75, have a body mass index value (BMI) between 22-40 kg/m2, be physician diagnosed with type 2 diabetes for at least six (6) months and currently controlling their blood glucose levels using dietary methods, exercise and/or through the use of oral hypoglycemic agents such as Metformin for at least three(3)months, and have an HbA1c <10%.

Exclusion Criteria:

  • Exclusion criteria included: the presence of unresolved health issues (e.g. hypertension not controlled by medication), evidence of condition(s) that would influence the participant's ability to complete the study such as gastrointestinal disease, weight changes of ≥10% of the participants body weight within a 6 month period, women who are either pregnant or breastfeeding, allergy to beans or latex, an HbA1c level >10% at screening, and the inability to follow study protocol.

Sites / Locations

  • Arizona State University, Nutrition Program

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Cross-over study

Arm Description

beans and rice in a 50 gram carbohydrate dose

Outcomes

Primary Outcome Measures

Net blood glucose changes over time
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.

Secondary Outcome Measures

Full Information

First Posted
October 27, 2010
Last Updated
October 29, 2019
Sponsor
Arizona State University
Collaborators
United States Dry Bean Council
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1. Study Identification

Unique Protocol Identification Number
NCT01241253
Brief Title
Glycemic Response of Bean-and-rice Meals in Type 2 Diabetes Mellitus
Official Title
Glycemic Response of Bean-and-rice Meals in Persons With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arizona State University
Collaborators
United States Dry Bean Council

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: The test meals containing the three bean types in combination with white rice will decrease the participants' glycemic response when eaten as part of a meal. The reduction in post-prandial glycemia will not differ between bean types in the elicited responses among individuals with type 2 diabetes.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Glucose, Type 2 Diabetes Mellitus
Keywords
legumes, glycemic response, glucose, type 2 diabetes mellitus

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cross-over study
Arm Type
No Intervention
Arm Description
beans and rice in a 50 gram carbohydrate dose
Intervention Type
Other
Intervention Name(s)
Whole cooked beans with rice meals
Other Intervention Name(s)
Bush Brothers & Company brand canned beans
Intervention Description
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.
Primary Outcome Measure Information:
Title
Net blood glucose changes over time
Description
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.
Time Frame
fasting baseline glucose at time 0, then 30, 60, 90, 120, 150, and 180 minutes postprandial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eligible subjects will be between the ages of 35 and 75, have a body mass index value (BMI) between 22-40 kg/m2, be physician diagnosed with type 2 diabetes for at least six (6) months and currently controlling their blood glucose levels using dietary methods, exercise and/or through the use of oral hypoglycemic agents such as Metformin for at least three(3)months, and have an HbA1c <10%. Exclusion Criteria: Exclusion criteria included: the presence of unresolved health issues (e.g. hypertension not controlled by medication), evidence of condition(s) that would influence the participant's ability to complete the study such as gastrointestinal disease, weight changes of ≥10% of the participants body weight within a 6 month period, women who are either pregnant or breastfeeding, allergy to beans or latex, an HbA1c level >10% at screening, and the inability to follow study protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna M Winham, DrPH
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona State University, Nutrition Program
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85212
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22494488
Citation
Thompson SV, Winham DM, Hutchins AM. Bean and rice meals reduce postprandial glycemic response in adults with type 2 diabetes: a cross-over study. Nutr J. 2012 Apr 11;11:23. doi: 10.1186/1475-2891-11-23.
Results Reference
result
PubMed Identifier
22916816
Citation
Hutchins AM, Winham DM, Thompson SV. Phaseolus beans: impact on glycaemic response and chronic disease risk in human subjects. Br J Nutr. 2012 Aug;108 Suppl 1:S52-65. doi: 10.1017/S0007114512000761.
Results Reference
result
PubMed Identifier
28976933
Citation
Winham DM, Hutchins AM, Thompson SV. Glycemic Response to Black Beans and Chickpeas as Part of a Rice Meal: A Randomized Cross-Over Trial. Nutrients. 2017 Oct 4;9(10):1095. doi: 10.3390/nu9101095.
Results Reference
result

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Glycemic Response of Bean-and-rice Meals in Type 2 Diabetes Mellitus

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