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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

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

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

Learn more about this trial

Pinto Beans and Glycemic Control in Adults With Type 2 Diabetes

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