Pinto Beans and Glycemic Control in Adults With Type 2 Diabetes

Not Applicable

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT04003194
• Lead Sponsor: University of Colorado, Colorado Springs

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.

Study Timeline

• Study Start: 2009-03-01
• Primary Completion: 2010-12-31
• Study Completion: 2010-12-31
• Status Verified: 2019-06
• Study First Submitted: 2019-06-24
• Study First Submitted QC: 2019-06-28
• Last Update Submitted: 2019-06-28
• Study First Posted: 2019-07-01
• Last Update Posted: 2019-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in Glucose	12 weeks pre and post	Change in fasting blood glucose levels

Secondary Outcome Measures

Name	Time	Method
Change in Hemoglobin A1c	12 weeks pre and post	Change in Blood hemoglobin A1c
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