Pinto Beans and Glycemic Control in Adults With Type 2 Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Pinto Beans as Part of a Normal Diet on Glycemic Control in Adults With Type 2 Diabetes: a Randomized Trial

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: Pinto Beans
* Other: Green Beans - control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Crossover Assignment Crossover design with 2-12 week intervention and comparator phases separated by a 4-week washout.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pinto beans<br>1/2 cup pinto beans eaten daily by free-living individuals for 12 consecutive weeks. | Other: Pinto Beans<br>* The intervention was 1/2 cup of pinto beans each day.<br>* Other names: Pinto Beans - intervention;|
| Active Comparator: Green beans<br>1/2 cup green beans eaten daily by free-living individuals for 12 consecutive weeks. | Other: Green Beans - control<br>* The control was 1/2 cup of green beans each day.<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glucose | Change in fasting blood glucose levels | 12 weeks pre and post | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial glucose | 1 time per week from week 1 of each intervention to week 12 of each intervention | 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 | 12 weeks pre and post | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulses, legumes, Phaseolus vulgaris L., glycemic response