Pinto Beans and Glycemic Control in Adults With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pinto Beans
Green Beans - control
Sponsored by
About this trial
This is an interventional basic science trial for Type 2 Diabetes focused on measuring pulses, legumes, Phaseolus vulgaris L., glycemic response
Eligibility Criteria
Inclusion Criteria:
- diagnosis of T2DM by a physician;
- currently attempting control of T2DM by diet or metformin;
- fasting glucose ≥ 90 mg/dL (confirmed by fasting blood draw or potential participant provided lab analysis conducted within last 30 days) and/or hemoglobin A1C ≥ 6.5% (confirmed by blood draw or potential participant provided lab analysis conducted within last 30 days);
- body mass index (BMI) of 22-40 kg/m2;
- no unresolved health conditions and no diagnosis of gastrointestinal disease;
- limited history of legume intake;
- willingness to follow study protocol, scheduling, and ability to come to the testing location;
- no recent weight gain or loss (>10% over 6 months);
- no use of medications and/or dietary supplements other than metformin that affected glucose;
- women could not be pregnant or breastfeeding;
- habitual alcohol consumption had to be less than 2 drinks per day (specifically ≤ 720 ml of beer, 240 ml of wine, or 90 ml of hard liquor).
Exclusion Criteria:
- Non compliance with above inclusion criteria.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pinto beans
Green beans
Arm Description
1/2 cup pinto beans eaten daily by free-living individuals for 12 consecutive weeks.
1/2 cup green beans eaten daily by free-living individuals for 12 consecutive weeks.
Outcomes
Primary Outcome Measures
Change in Glucose
Change in fasting blood glucose levels
Secondary Outcome Measures
Postprandial glucose
1 time per week from week 1 of each intervention to week 12 of each intervention
Change in Hemoglobin A1c
Change in Blood hemoglobin A1c
Full Information
NCT ID
NCT04003194
First Posted
June 24, 2019
Last Updated
June 28, 2019
Sponsor
University of Colorado, Colorado Springs
Collaborators
Iowa State University
1. Study Identification
Unique Protocol Identification Number
NCT04003194
Brief Title
Pinto Beans and Glycemic Control in Adults With Type 2 Diabetes
Official Title
Impact of Pinto Beans as Part of a Normal Diet on Glycemic Control in Adults With Type 2 Diabetes: a Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2009 (Actual)
Primary Completion Date
December 31, 2010 (Actual)
Study Completion Date
December 31, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Colorado, Colorado Springs
Collaborators
Iowa State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study examines the impact of daily consumption of ½ c pinto beans, compared to a control (½ c green beans), on fasting glucose, postprandial glucose and HbA1c concentrations in adults with type 2 diabetes mellitus (T2DM).
Detailed Description
This study utilized a randomized, pretest-posttest, crossover (within-group) design, that includes two treatment periods [control period (½ c. green beans each day) and pinto beans (½ c each day)], each 12-weeks in duration with a 4- week wash-out period to determine the impact on fasting glucose, postprandial glucose and HbA1c concentrations. After a baseline wash-in period, 16 participants are randomly assigned to 2 treatment periods [control period and pinto beans], each 12-weeks in duration. On 28 randomized days during the wash-in period and interventions, participants keep diet records and measure a postprandial capillary glucose concentration using a glucometer 1 hour after the meal during which the pinto beans or control are consumed. Before and after each 12-week intervention, participants provide a fasted venous blood sample for glucose and HbA1c analyses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
pulses, legumes, Phaseolus vulgaris L., glycemic response
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover Assignment Crossover design with 2-12 week intervention and comparator phases separated by a 4-week washout.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pinto beans
Arm Type
Experimental
Arm Description
1/2 cup pinto beans eaten daily by free-living individuals for 12 consecutive weeks.
Arm Title
Green beans
Arm Type
Active Comparator
Arm Description
1/2 cup green beans eaten daily by free-living individuals for 12 consecutive weeks.
Intervention Type
Other
Intervention Name(s)
Pinto Beans
Other Intervention Name(s)
Pinto Beans - intervention
Intervention Description
The intervention was 1/2 cup of pinto beans each day.
Intervention Type
Other
Intervention Name(s)
Green Beans - control
Other Intervention Name(s)
Control
Intervention Description
The control was 1/2 cup of green beans each day.
Primary Outcome Measure Information:
Title
Change in Glucose
Description
Change in fasting blood glucose levels
Time Frame
12 weeks pre and post
Secondary Outcome Measure Information:
Title
Postprandial glucose
Description
1 time per week from week 1 of each intervention to week 12 of each intervention
Time Frame
1 time per week from week 1 of each intervention to week 12 of each intervention
Title
Change in Hemoglobin A1c
Description
Change in Blood hemoglobin A1c
Time Frame
12 weeks pre and post
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of T2DM by a physician;
currently attempting control of T2DM by diet or metformin;
fasting glucose ≥ 90 mg/dL (confirmed by fasting blood draw or potential participant provided lab analysis conducted within last 30 days) and/or hemoglobin A1C ≥ 6.5% (confirmed by blood draw or potential participant provided lab analysis conducted within last 30 days);
body mass index (BMI) of 22-40 kg/m2;
no unresolved health conditions and no diagnosis of gastrointestinal disease;
limited history of legume intake;
willingness to follow study protocol, scheduling, and ability to come to the testing location;
no recent weight gain or loss (>10% over 6 months);
no use of medications and/or dietary supplements other than metformin that affected glucose;
women could not be pregnant or breastfeeding;
habitual alcohol consumption had to be less than 2 drinks per day (specifically ≤ 720 ml of beer, 240 ml of wine, or 90 ml of hard liquor).
Exclusion Criteria:
Non compliance with above inclusion criteria.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pinto Beans and Glycemic Control in Adults With Type 2 Diabetes
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