Pinto Beans and Glycemic Control in Adults With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04003194
• Other study ID #: UCCS09-028
• Status: Completed
• Phase: N/A
• Start date: March 1, 2009
• Est. completion date: December 31, 2010

Study information

• Verified date: June 2019
• Source: University of Colorado, Colorado Springs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 31, 2010
• Est. primary completion date: December 31, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• Pinto Beans
The intervention was 1/2 cup of pinto beans each day.
• Green Beans - control
The control was 1/2 cup of green beans each day.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Colorado Springs	Iowa State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glucose	Change in fasting blood glucose levels	12 weeks pre and post
Secondary	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
Secondary	Change in Hemoglobin A1c	Change in Blood hemoglobin A1c	12 weeks pre and post